A randomized controlled trial of cell salvage in routine cardiac surgery. Mechanical methods of reducing blood transfusion in cardiac surgery: randomised controlled trial. Reducing allogeneic transfusion in cardiac surgery: a randomized double-blind placebo-controlled trial of antifibrinolytic therapies used in addition to intra-operative cell salvage. Cell salvage auto transfusion in total knee replacement surgery. A randomized trial on the efficacy of an autologous blood drainage and transfusion device in patients undergoing elective knee arthroplasty. Quality of the blood sampled from surgical drainage after total hip arthroplasty. Efficacy of cell saver in reducing homologous blood transfusions during OPCAB surgery: a prospective randomized trial. Combination of acute preoperative plateletpheresis, cell salvage, and aprotinin minimizes blood loss and requirement during cardiac surgery. A randomized trial of tranexamic acid in combination with cell salvage plus a meta-analysis of randomized trials evaluating tranexamic acid in off-pump coronary artery bypass grafting. Safety, efficacy, and cost of intraoperative cell salvage and autotransfusion after off-pump coronary artery bypass surgery: a randomized trial. Autologous blood transfusion in total knee replacement surgery. Efficacy, safety and user-friendliness of two devices for postoperative autologous shed red blood cell re-infusion in elective orthopaedic surgery patients: A randomized pilot study. Blood salvage in cardiac surgery. Safety and efficacy of perioperative cell salvage and autotransfusion after coronary artery bypass grafting: a randomized trial. A prospective randomized trial of acute normovolemic hemodilution compared to standard intraoperative management in patients undergoing major hepatic resection. Autotransfusion with cell saver for off-pump coronary artery bypass surgery: a randomized trial. Efficacy of a simple intraoperative transfusion algorithm for nonerythrocyte component utilization after cardiopulmonary bypass. Blood conservation in small adults undergoing valve surgery. The effect of postoperative wound drainage reinfusion in reducing the need for blood transfusions in elective total joint arthroplasty: a prospective, randomized study. Autologous blood transfusion after primary unilateral total knee replacement surgery. Prospective randomized evaluation of blood salvage techniques for primary total hip arthroplasty. Autotransfusion after coronary artery bypass surgery: is there any benefit? The clinical study of autologous peripheral blood stem cell transplantation by intracoronary infusion in patients with acute myocardial infarction (AMI). Preoperative autologous blood donation reduces the need for allogeneic blood products: a prospective randomized study. Effect of epsilon aminocaproic acid on red-cell transfusion requirements in major spinal surgery. Should the Cell Saver Autotransfusion Device be used routinely in all infrarenal abdominal aortic bypass operations? Thromboelastography-based transfusion algorithm reduces blood product use after elective CABG: a prospective randomized study. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. Blood transfusion-modulated tumor recurrence: first results of a randomized study of autologous versus allogeneic blood transfusion in colorectal cancer surgery. A randomized trial of intraoperative autotransfusion during aortic surgery. Tranexamic acid and aprotinin reduce postoperative bleeding and transfusions during primary coronary revascularization. In adults with standard-risk acute lymphoblastic leukemia, the greatest benefit is achieved from a matched sibling allogeneic transplantation in first complete remission, and an autologous transplantation is less effective than conventional consolidation/maintenance chemotherapy in all patients: final results of the International ALL Trial (MRC UKALL XII/ECOG E2993). A pilot study of the effects of Vivostat patient-derived fibrin sealant in reducing blood loss in primary hip arthroplasty. A multicenter pilot-randomized controlled trial of the feasibility of an augmented red blood cell transfusion strategy for patients treated with induction chemotherapy for acute leukemia or stem cell transplantation. Evaluation of autologous shed blood for autotransfusion after orthopaedic surgery. Use of activated recombinant coagulation factor VII in patients undergoing reconstruction surgery for traumatic fracture of pelvis or pelvis and acetabulum: a double-blind, randomized, placebo-controlled trial. Safety and therapeutic effectiveness of reinfused shed blood after open heart surgery. Blood salvage after total hip arthroplasty. The reduction of the allogenic transfusion requirement in aortic surgery with a hemoglobin-based solution. The beneficial effect of human recombinant superoxide dismutase on acute and chronic rejection events in recipients of cadaveric renal transplants. Prospective, randomized trial of autotransfusion after routine cardiac operations. The impact of intraoperative autotransfusion on cardiac surgery. A prospective randomized double-blind study. The role of autologous blood transfusion in joint replacement surgery. Postoperative blood salvage in total hip and knee arthroplasty. A randomised controlled trial. Haemodilutional effect of standard fluid management limits the effectiveness of acute normovolaemic haemodilution in AAA surgery--results of a pilot trial. Allogeneic stem cell transplantation in acute lymphoblastic leukemia and non-Hodgkin's lymphoma for patients <or=50 years old in first complete remission: results of the EORTC ALL-3 trial. Allogeneic versus autologous blood during abdominal aortic aneurysm surgery. Tranexamic acid and aprotinin in primary cardiac operations: an analysis of 220 cardiac surgical patients treated with tranexamic acid or aprotinin. An evaluation of the efficacy of postoperative blood salvage after total joint arthroplasty. A prospective randomized trial. Randomized, placebo-controlled, double-blind study of an ultra-low-dose aprotinin regimen in reoperative and/or complex cardiac operations. A controlled trial of educational outreach to improve blood transfusion practice. Intraoperative plateletpheresis and autologous platelet gel do not reduce chest tube drainage or allogeneic blood transfusion after reoperative coronary artery bypass graft. Reduction of blood utilization during myocardial revascularization. A randomized comparison of transfusion triggers in elective orthopaedic surgery using leucocyte-depleted red blood cells. Tranexamic Acid reduces perioperative blood loss in adult patients having spinal fusion surgery. Preoperative use of recombinant human erythropoietin before total joint arthroplasty. Intraoperative blood salvage during liver resection: a randomized controlled trial. Thromboelastography-guided transfusion algorithm reduces transfusions in complex cardiac surgery. Myeloablative allogeneic versus autologous stem cell transplantation in adult patients with acute lymphoblastic leukemia in first remission: a prospective sibling donor versus no-donor comparison. Efficacy of autologous fresh whole blood or platelet-rich plasma in adult cardiac surgery. Blood transfusions and prognosis in colorectal cancer. Prophylactic tranexamic acid in elective, primary coronary artery bypass surgery using cardiopulmonary bypass. Effects of cell saver autologous blood transfusion on blood loss and homologous blood transfusion requirements in patients undergoing cardiac surgery on- versus off-cardiopulmonary bypass: a randomised trial. Impact of autotransfusion after coronary artery bypass grafting on oxygen transport. [Blood transfusion and survival of patients with neoplasms of the colon and rectum]. Randomised controlled trial comparing transfusion of leucocyte-depleted or buffy-coat-depleted blood in surgery for colorectal cancer. Storage time of transfused blood and disease recurrence after colorectal cancer surgery. The effectiveness of reinfusion after total knee replacement. A prospective randomised controlled study. Autologous transplantation of granulocyte colony-stimulating factor-mobilized peripheral blood mononuclear cells improves critical limb ischemia in diabetes. Tranexamic acid reduces blood loss and transfusion in reoperative cardiac surgery.
Previous trials have indicated that cell salvage may reduce allogeneic blood transfusion during cardiac surgery, but these studies have limitations, including inconsistent use of other blood transfusion-sparing strategies. We designed a randomized controlled trial to determine whether routine cell salvage for elective uncomplicated cardiac surgery reduces blood transfusion and is cost effective in the setting of a rigorous transfusion protocol and routine administration of antifibrinolytics.
                Two-hundred-thirteen patients presenting for first-time coronary artery bypass grafting and/or cardiac valve surgery were prospectively randomized to control or cell salvage groups. The latter group had blood aspirate during surgery and mediastinal drainage the first 6 h after surgery processed in a cell saver device and autotransfused. All patients received tranexamic acid and were subjected to an algorithm for red blood cell and hemostatic blood factor transfusion.
                There was no difference between the two groups in the proportion of patients exposed to allogeneic blood (32% in both groups, relative risk 1.0 P = 0.89). At current blood products and cell saver prices, the use of cell salvage increased the costs per patient by a minimum of $103. When patients who had mediastinal re-exploration for bleeding were excluded (as planned in the protocol), significantly fewer units of allogeneic red blood cells were transfused in the cell salvage compared with the control group (65 vs 100 U, relative risk 0.71 P = 0.04).
                In patients undergoing routine first-time cardiac surgery in an institution with a rigorous blood conservation program, the routine use of cell salvage does not further reduce the proportion of patients exposed to allogeneic blood transfusion. However, patients who do not have excessive bleeding after surgery receive significantly fewer units of blood with cell salvage. Although the use of cell savage may reduce the demand for blood products during cardiac surgery, this comes at an increased cost to the institution. To assess the effectiveness of two mechanical methods of blood conservation in reducing the need for allogeneic red blood cells or coagulation products during cardiac surgery.
                Randomised controlled trial.
                Regional cardiac centre in a teaching hospital in Southampton.
                263 adults aged 18-80 years undergoing elective coronary artery bypass surgery entered the study, of whom 252 completed the trial. All patients received routine perioperative care. Patients were allocated to one of three treatment groups: intraoperative cell salvage, intraoperative cell salvage with acute perioperative normovolaemic haemodilution, or no mechanical blood conservation. There were 84 patients in each group.
                Numbers of patients who received allogeneic blood or coagulation products, and the mean number of units of blood transfused per patient.
                Of the patients in the intraoperative cell salvage group, 26 were given a transfusion of allogeneic blood, compared with 43 in the control group (odds ratio 0.43 (95% confidence interval 0.23 to 0.80)). The mean number of units of allogeneic blood transfused per patient in the intraoperative cell salvage group was 0.68 units (SD=1.55), compared with 1.07 (1.56) units in the control group. 32 of the patients in the intraoperative cell salvage group were given any blood product, compared with 47 in the control group (odds ratio 0.47 (0.25 to 0.89); P=0.019). Combining acute perioperative normovolaemic haemodilution with intraoperative cell salvage conferred no additional benefits.
                An intraoperative cell salvage device should be used in elective coronary artery bypass grafting. Pharmacological strategies may achieve further reductions in blood transfusions. Yet further reductions in blood transfusions could be achieved if the lower safe limit of haemoglobin concentration in patients undergoing cardiac surgery were known. The transfusion of allogeneic red blood cells and allogeneic coagulation products is associated with risk to the patient and the depletion of an increasingly scarce resource. This prospective, randomized, double-blind, placebo-controlled trial investigated practices to avoid transfusion in patients undergoing first-time cardiac surgery.
                Patients were randomized to one of three treatment groups: an aprotinin group, a tranexamic acid group, and a control group receiving normal saline. Intra-operative cell salvage was used for all patients. The primary outcomes were the number of patients exposed to allogeneic red blood cells, allogeneic coagulation products or any allogeneic transfusion (allogeneic red blood cells and/or allogeneic coagulation products).
                Patients were 2.5 times more likely to receive any allogeneic transfusion in the tranexamic group than in the aprotinin group (21 patients out of 60 compared with nine out of 60, respectively). The relative risk of any allogeneic transfusion comparing aprotinin with tranexamic acid was 0.43 (95% confidence interval 0.21-0.86; P=0.019). Patients in the control group were four times more likely to receive any allogeneic transfusion when compared with the aprotinin group (37 patients out of 60 compared with nine out of 60, respectively). The relative risk of any allogeneic transfusion comparing aprotinin with control was 0.24 (95% confidence interval 0.13-0.46; P<0.001).
                When used in addition to intra-operative cell salvage, aprotinin is the most efficacious pharmacological therapy for reducing patient exposure to any allogeneic transfusion during first-time cardiac surgery. We conducted a prospective, randomized study to assess the impact of cell salvage, auto transfusion on the requirements for allogeneic blood for patients undergoing a total knee replacement (TKR). One hundred consecutive TKR patients were randomly allocated to receive either autologous blood (using cell salvage) or an allogeneic blood transfusion as necessary. Patients allocated to the autologous group were rescued with allogeneic blood if the postoperative haemoglobin fell below 9 g dL-1. Forty-two (84%) of 50 patients in the autologous group required no supplementary blood transfusion. Forty (80%) of 50 patients allocated to receive allogeneic blood required transfusion. There were no detrimental effects of autologous blood transfusion. We conclude that autologous blood transfusion, using the cell saver system, is a safe and effective method of reducing the need for allogeneic blood transfusion and, in doing so, reduces the risk of transmission of infections associated with allogeneic blood transfusion, whilst decreasing demand on precious allogeneic blood reserves. The purpose of the study reported here was the determination of the efficacy of a postoperative autologous blood drainage and transfusion device in reducing allogeneic red cell requirements in patients undergoing elective knee arthroplasty. The study was a randomized controlled trial with adult patients undergoing unilateral elective arthroplastic knee surgery. Patients underwent suction drainage, attached to an autologous blood drainage and transfusion device, or standard suction drainage. Allogeneic red cells were given according to strict transfusion guidelines based on blood loss and postoperative hemoglobin values. Outcome measures included the mean number of allogeneic red cell concentrates required and the number of patients in each group who required no transfusion. Patients assigned to standard suction drainage had a mean allogeneic red cell utilization of 1.2 units (SD 1.0), as compared to a mean of 0.4 units (SD 0.8) in the group undergoing drainage with the autologous blood drainage and transfusion device (p = 0.0007). The percentage of patients not requiring allogeneic red cells was significantly higher in the latter group (74.3% vs. 32.5%; p = 0.002). The postoperative drainage and transfusion device was efficacious in reducing the amount of allogeneic red cells required by patients undergoing knee arthroplasty, and its use resulted in a 42 percent reduction in the number of patients requiring allogeneic transfusion. Several methods have been found to be successful in reducing the need for allogeneic transfusion among the patients undergoing total hip replacement. The purpose of this prospective study was to analyse the quality and evaluate the effect of postoperative autotransfusion on the need for allogeneic transfusion following total hip replacement. The prospective study was performed in two groups of patients undergoing total hip replacement. Before the operative procedure all patients in both groups predonated two doses of autologous blood. In GROUP 1. the system for postoperative collection and transfusion of shed blood was used. In GROUP 2. the patients underwent total hip replacement without blood salvage system. Standard suction collection sets were used postoperatively. In this group shed blood was not transfused to the patients. The samples of preoperative donated autologus blood, allogeneic blood and postoperative collected autologous blood were analysed for number of red cells, hemoglobin, hematocrit, platelets, white blood cells, values of potassium, sodium, free hemoglobin and acid base status. The postoperatively blood salvage significantly reduced the use of allogeneic transfusion among patients managed with total hip replacement (allogeneic transfusion received 12% patients in Group 1 and 80% patients in Group 2; p<0.001). The values of red blood cells are significantly lower in postoperative collected autotransfusion blood compared with preoperative collected autologous blood and allogeneic blood (p<0.001). The values of potassium and acid base status were in normal range in postoperatively collected autotransfusion blood. These values in preoperatively collected autologous blood and allogeneic blood were out of normal range; (p<0.001). In addition to reducing the risk of complications that are associated with allogeneic transfusion, postoperative blood salvage may offer benefits including reducing the need for allogeneic blood. Our study confirmed that postoperative collection and transfusion of drainaged blood is simple and safe method that significantly reduce the need for allogeneic transfusion in patients underwent total hip replacement. The blood collected and transfused postoperatively has lower values of red blood cells and normal values of potassium and acid base balance. The transfusion of this blood caused no complications in our patients. Despite the refinements in surgical technique, rates of homologous blood transfusion (HBT) in cardiac surgery remain high. The adverse effects of blood transfusion are well documented. Retransfusion of shed mediastinal blood reduces the requirement for HBTs during conventional coronary artery bypass grafting. However, some studies have found that autotransfusion leads to bleeding diathesis and paradoxical increase in blood transfusions. Through this prospective randomized trial, we have studied the safety and efficacy of this modality in patients undergoing off-pump coronary artery bypass grafting (OPCAB). Fifty patients enrolled in the study and 49 fulfilled the study criteria. They were randomly divided into group C (cell saver) and group N (non-cell saver). Whereas the cell saver group received processed shed autologous blood and homologous blood if necessary, the non-saver group was transfused homologous blood only. The threshold for transfusion was haemoglobin of 9 g dL(-1) in both the groups. The cell saver group required significantly less number of HBTs (1.6 +/- 1.2 vs. 2.4 +/- 1.3 units). The incidence of re-exploration was zero in both the groups. The mean mediastinal drainage in both the groups was not significantly different (355 +/- 196 vs. 316 +/- 119.8 mL). The number of patients requiring any blood transfusion however was very high. All the patients in the non-saver group and 20 (83%) of the patients in the saver group received homologous blood. During OPCAB surgery, the use of cell saver reduced the requirement for HBT. Its use is not associated with any clinically significant bleeding diathesis. Acute preoperative plateletpheresis (APP), cell salvage (CS) technique, and the use of aprotinin have been individually reported to be effective in reducing blood loss and blood component transfusion while improving hematological profiles in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). In this prospective randomized clinical study, the efficacy of these combined approaches on reducing blood loss and transfusion requirements was evaluated. Seventy patients undergoing primary coronary artery bypass grafting (CABG) were randomly divided into four groups: a control group (group I, n = 10) did not receive any of the previously mentioned approaches. An APP and CS group (group II, n = 20) experienced APP in which preoperative platelet-rich plasma was collected and reinfused after reversal of heparin, along with the cell salvage technique throughout surgery. The third group (group III, n = 22) received aprotinin in which 5,000,000 KIU Trasylol was applied during surgery, and a combination group (group IV, n = 18) was treated with all three approaches, i.e., APP, CS, and aprotinin. Compared with group I (896+/-278 mL), the postoperative total blood loss was significantly reduced in groups II, III, and IV (468+/-136, 388+/-122, 202+/-81 mL, respectively, p < 0.05). The requirements of packed red blood cells in the three approached groups (153+/-63, 105+/-178, 0+/-0 mL, respectively) also were reduced when compared with group I (343+/-118 mL, p < 0.05). In group I, six patients (6/10) received fresh-frozen plasma and three patients (3/10) received platelet transfusion, whereas no patients in the other three groups required fresh-frozen plasma and platelet. In conclusion, both plateletpheresis concomitant with cell salvage and aprotinin contribute to the improvement of postoperative hemostasis, and the combination of these two approaches could minimize postoperative blood loss and requirement. We sought to evaluate the effectiveness of tranexamic acid in off-pump coronary artery bypass grafting surgery, either when used in combination with mechanical cell salvage or when used alone.
                One hundred patients were randomized to either 2 g of tranexamic acid as an intravenous bolus before sternotomy or to placebo. Intraoperative and postoperative cell salvage was used in all patients. The primary end point was early postoperative blood loss (within 4 hours). To evaluate the efficacy of tranexamic acid in isolation, we also performed a meta-analysis of 4 randomized trials identified from a systematic literature search. The primary end point of the meta-analysis was red cell transfusion.
                In our randomized trial patients in the tranexamic acid group had a significant reduction in early postoperative blood loss, (median difference, 50 mL; 95% confidence interval, 15-100 mL; P < .01); however, there was no reduction in the frequency of blood component transfusion. Patients in the placebo group received a significantly larger volume of autotransfused red cells (median difference, 120 mL; 95% confidence interval, 0-220 mL; P = .02). The meta-analysis demonstrated a significant reduction in red cell transfusions in patients receiving tranexamic acid compared with those receiving placebo (risk ratio, 0.48; 95% confidence interval, 0.24-0.97; P = .041). There was also a reduction in the frequency of any allogeneic blood component transfusion, as well as a highly significant reduction in postoperative blood loss, in patients receiving tranexamic acid (P < .001).
                Tranexamic acid reduces blood loss and transfusion requirements in off-pump coronary artery bypass grafting surgery. A reduction in allogeneic blood transfusion was not evident in the presence of perioperative cell salvage. These data support the routine use of tranexamic acid in off-pump coronary artery bypass grafting surgery. We evaluated, in a randomized controlled trial, the safety and effectiveness of intraoperative cell salvage and autotransfusion of washed salvaged red blood cells after first-time coronary artery bypass grafting performed on the beating heart.
                Sixty-one patients undergoing off-pump coronary artery bypass grafting surgery were prospectively randomized to autotransfusion (n = 30; receiving autotransfused washed blood from intraoperative cell salvage) or control (n = 31; receiving homologous blood only as blood-replacement therapy). Homologous blood was given according to unit protocols.
                The groups were well matched with respect to demographic and comorbid characteristics. Patients in the autotransfusion group had a significantly higher 24-hour postoperative hemoglobin concentration (11.9 g/dL; SD, 1.41 g/dL) than those in the control group (10.5 g/dL; SD, 1.37 g/dL) (mean difference, 1.02 g/dL; 95% confidence interval, 1.60-0.44 g/dL; P = .0007), as well as a 20% reduction in the frequency of homologous blood product use (11/31 vs 5/30; P = .095). Autotransfusion of washed red blood cells was not associated with any derangement of thromboelastograph values or laboratory measures of clotting pathway function (prothrombin time, activated partial thromboplastin time, and fibrinogen levels), increased postoperative bleeding, fluid requirements, or adverse clinical events. There was no statistical difference between groups in the total operation, hospitalization, and management costs per patient (median difference, USD 1015.90; 95% confidence interval, -USD 2260 to USD 206; P = .11). Conclusions Intraoperative cell salvage and autotransfusion was associated with higher postoperative hemoglobin concentrations, a modest reduction in transfusion requirements, no adverse clinical or coagulopathic effects, and no significant increase in cost compared with controls. This study supports its routine use in off-pump coronary artery bypass grafting surgery. We compared allogeneic blood usage for two groups of patients undergoing total knee replacement surgery (TKR). Patients were randomized to receive either their post-operative wound drainage as an autotransfusion (n=115) after processing or to have this wound drainage discarded (n=116). Allogeneic blood was transfused in patients of either group whose haemoglobin fell below 9 g dl(-1). Only 7% of patients in the autotransfusion group required an allogeneic transfusion compared with 28% in the control group (P<0.001). There was no hospital mortality and only 3% mortality from all causes at the study completion, which spanned 6 months to 3 yr. There was a higher incidence of infection requiring intervention in the allogeneic group (P<0.036). Total patient costs were Pound Sterling 113 greater in the autotransfusion group. We conclude that in this type of surgery post-operative cell salvage is a safe and effective method for reducing allogeneic blood use. To determine the safety, efficacy and user-friendliness of two different postoperative autologous blood re-infusion systems, an open, randomized, controlled study was performed. Eligible consecutive primary and revision total hip and knee replacement patients were randomized for one of the two systems or for a control group in which shed blood was not re-infused. The nursing staff scored user-friendliness. Patients were monitored after re-infusion. In all three patient groups, a restrictive transfusion trigger was used. Sixty-nine of 70 randomized patients were evaluated. Ease of use, efficacy and safety of both re-infusion systems were comparable. There was no difference in allogeneic blood use between the groups. Thirty per cent of the patients re-infused with autologous blood developed a mainly mild, febrile transfusion reaction. No other adverse reactions were seen. Signs of coagulopathy after re-infusion were not found. In multivariate analysis, autologous re-infusion was an independent factor associated with a shorter hospital stay. Both postoperative autologous blood re-infusion systems were of equal efficacy and safety. The contribution of autologous wound blood re-infusion to reduce allogeneic transfusions must be investigated in a larger study. The aim of this study was to evaluate blood salvage provided by an intraoperative blood recovery system (IBRS) and a mediastinal drainage blood recovery system (MBRS) during and after cardiac surgery. Sixty-six patients undergoing aortocoronary bypass surgery were randomly assigned to three groups of 22 patients each. In group I, patients received only homologous blood (HB). Group II and group III patients received the blood content of the oxygenator after concentration by an IBRS at the end of the operation. In group III, patients also received their own mediastinal drainage blood, shed for 6 hours after operation, after concentration and washing in a MBRS. The patients were transfused with homologous blood if needed, in order to obtain a hematocrit of 28% at the end of operation, 30% the following day, and a hemoglobin level over 10 g/dL while on the cardiac surgery ward (8 to 10 days). The three groups were comparable with respect to age, body surface, preoperative and postoperative hematocrits, number of grafts, bypass duration, and postoperative mediastinal blood loss. The amount of HB that was transfused during the operation was significantly lower in groups II and III than in group I (P less than 0.0001). After the operation it was significantly lower in group II than in group I (P less than 0.05), and in group III versus group I. Thus, 13.6% of patients in group II and 38% of patients in group III did not require HB transfusion. No infection, renal dysfunction, or coagulation disorders were observed. It is concluded that the use of an IBRS allows a significant saving of HB. However, because it does not avoid all HB requirements, it should be associated with other techniques to avoid blood transfusion such as the MBRS or predonation. The aim of this study was to ascertain whether cell salvage and autotransfusion after first time elective coronary artery bypass grafting is associated with a significant reduction in the use of homologous blood, a clinically significant derangement of postoperative clotting profiles, or an increased risk of postoperative bleeding.
                Patients were randomized to autotransfusion (n = 98) receiving autotransfused washed blood from intraoperative cell salvage and postoperative mediastinal fluid cell salvage after coronary artery bypass surgery or control (n = 102) receiving stored homologous blood only after coronary artery bypass surgery.
                There was no statistical difference between the groups in terms of demographics, comorbidity, risk stratification, or operative details. Mean volume of blood autotransfused was 367 +/- 113 mL. Patients in the autotransfusion group were significantly less likely to receive a homologous blood transfusion compared with controls (odds ratio 0.40, 95% confidence interval [CI] 0.22-0.71) and received significantly fewer units of blood per patient compared with controls (0.43 +/- 1.5 vs 0.90 +/- 2.0 U, p = 0.02). There was no difference between the groups in terms of postoperative blood loss, fluid requirements, blood product requirements, or in the incidence of adverse clinical events (p = NS chi(2)). Autotransfusion did not produce any significant derangement of thromboelastograph values or laboratory measures of clotting pathway function (prothrombin time, activated partial thromboplastin time, fibrinogen, and fibrinogen D-dimer levels) when compared with the effect of homologous blood transfusion (p = NS, repeated measures analysis of variance [MANOVA]).
                Autotransfusion is a safe and effective method of reducing the use of homologous bank blood after routine first time coronary artery bypass grafting. Hepatic resection is the most effective treatment for many malignant and benign conditions affecting the liver and biliary tree. Despite improvements, major partial hepatectomy can be associated with considerable blood loss and transfusion requirements. Transfusion of allogeneic blood products, although potentially life-saving, is associated with many potential complications. The primary aim of this study was to determine if acute normovolemic hemodilution (ANH), an established blood conservation technique, reduces the requirement for allogeneic red cell transfusions in patients undergoing major hepatic resection.
                One hundred thirty patients undergoing major hepatic resection (> or =3 segments) were prospectively randomized to undergo either ANH or standard anesthetic management (STD). In the ANH group, intraoperative blood collection was performed to a target hemoglobin of 8.0 g/dL. Low central venous pressure anesthetic technique was used intraoperatively for both groups. A standardized transfusion protocol was applied to all patients intraoperatively and throughout the hospital stay.
                From April 2004 to March 2007, 63 patients were randomized to ANH and 67 to STD. Demographics, diagnoses, liver function, extent of resection, intraoperative blood loss, operative time, incidence and grade of complications, and length of hospital stay were similar between the 2 groups. ANH reduced the overall allogeneic red cell transfusion rate by 50% compared with STD [12.7% (n = 8) vs. 25.4% (n = 17), respectively; P = 0.067. ANH patients were less often transfused intraoperatively (n = 1, 1.6%) compared with the STD group (n = 7, 10.4%) (P = 0.036), had higher postoperative hemoglobin levels (P = 0.01), and tended to require fewer red cell units overall (28 vs. 47 units). In patients with intraoperative blood loss > or =800 mL, ANH reduced not only the allogeneic red cell transfusion rate (18.2% vs. 42.4%, P = 0.045) but also the proportion of patients requiring fresh frozen plasma (21.1% vs. 48.3%, P = 0.025).
                For patients undergoing major liver resection, ANH is safe, effectively reduces the need for allogeneic transfusions, and should be considered for routine use. Given the modest transfusion rate in the STD arm, future efforts should attempt to target ANH use to patients most likely to benefit. Off-pump coronary surgery reduces transfusions, however, many patients still receive blood. This trial aims to clarify the effect of using a cell saver intraoperatively.
                In 60 patients shed blood was collected in the cell saver reservoir intraoperatively; randomization and processing or discharge were performed immediately after surgery. Primary outcome measures: proportion of patients receiving allogeneic blood, and average number of units per patient. Secondary outcome measures: blood loss, hemoglobin levels, complications, and costs.
                Cell saver group versus control group; received transfusions: 17/30 vs. 14/29 (p = 0.28), allogeneic units: median 1 (interquartile range 0 - 2) vs. 2 (IQR 0 - 7) (p = 0.06), intraoperative net blood loss: median 300 ml (IQR 193 - 403) vs. 610 ml (IQR 450 - 928) (p < 0.001). Control group patients had more complications leading to transfusion. Hemoglobin levels and costs were comparable between groups.
                Use of cell saver reduced intraoperative net blood loss and seemed to reduce transfusions by 1 unit per patient, however, this was probably attributable to more complications leading to transfusion in the control group. In the future larger trials are necessary. Abnormal bleeding after cardiopulmonary bypass (CPB) is a common complication of cardiac surgery, with important health and economic consequences. Coagulation test-based algorithms may reduce transfusion of non-erythrocyte allogeneic blood in patients with abnormal bleeding.
                The authors performed a randomized prospective trial comparing allogeneic transfusion practices in 92 adult patients with abnormal bleeding after CPB. Patients with abnormal bleeding were randomized to one of two groups: a control group following individual anesthesiologist's transfusion practices and a protocol group using a transfusion algorithm guided by coagulation tests.
                Among 836 eligible patients having all types of elective cardiac surgery requiring CPB, 92 patients developed abnormal bleeding after CPB (incidence, 11%). The transfusion algorithm group received less allogeneic fresh frozen plasma in the operating room after CPB (median, 0 units; range, 0-7 units) than the control group (median, 3 units; range, 0-10 units) (P = 0.0002). The median number of platelet units transfused in the operating room after CPB was 4 (range, 0-12) in the algorithm group compared with 6 (range, 0-18) in the control group (P = 0.0001). Intensive care unit (ICU) mediastinal blood loss was significantly less in the algorithm group. Multivariate analysis demonstrated that transfusion algorithm use resulted in reduced ICU blood loss. The control group also had a significantly greater incidence of surgical reoperation of the mediastinum for bleeding (11.8% vs. 0%; P = 0.032).
                Use of a coagulation test-based transfusion algorithm in cardiac surgery patients with abnormal bleeding after CPB reduced non-erythrocyte allogeneic transfusions in the operating room and ICU blood loss. A substantial reduction in transfusion requirements for cardiac surgical procedures has been reported. Many of these reports have been described in patients undergoing coronary artery bypass grafting. Patients suffering from rheumatic heart disease in India are usually small and also anemic. This study was conducted to assess blood conservation methods for cardiac valve surgery in this subset of patients.
                This was a prospective, randomized study.
                The study was performed in a New Delhi tertiary care hospital, and the patients were referred from the northern states of India.
                One hundred fifty consecutive patients undergoing elective valve surgery using cardiopulmonary bypass were included. The mean age was 27.7 years and mean weight was 45.2 kg.
                The patients were divided into three groups of 50 each. Group 1 received autologous fresh blood donated before bypass, and both a cell saver and membrane oxygenator were used. The oxygenator contents at the end of perfusion were processed by cell saver. Group 2 patients were reinfused with autologous blood only, and group 3 was a control group. In groups 2 and 3, the blood that remained in the oxygenator at the conclusion of cardiopulmonary bypass was reinfused. A hematocrit of less than 25% was considered an indication for transfusion in the postoperative period.
                The mean preoperative hematocrit was 35.5%. A mean of 361.1 mL of autologous blood was collected from group 1 and 303.3 mL from group 2. Group 1 required 15 units of bank blood, group 2, 90 units (p < 0.001), and group 3, 102 units (p < 0.001). Seventy-eight percent of group 1 patients did not receive any donor blood. There was no significant difference in chest tube drainage among the three groups.
                In this unique group of patients whose mean body weight was only 45 kg, autologous blood alone did not decrease blood bank requirements but when combined with a cell saver and membrane oxygenator greatly reduced the need for donor blood. A prospective, randomized study was conducted in 24 patients using the Solcotrans Orthopaedic Drainage Reinfusion System (Smith & Nephew Richards Inc, Memphis, Tenn) for postoperative blood salvage in total joint arthroplasty. The amount of postoperative autologous blood salvage averaged 946 mL. Only 25% of the study group required postoperative transfusions, compared to 83% of the control group (P = .016). In total knee arthroplasties, only 11% of the study group required transfusions, compared to 78% of the control group (P = .018). There were no transfusion reactions, infectious complications, or coagulopathies. Postoperative blood salvage is a safe, reliable, and effective source of autologous blood. A prospective study was undertaken to assess the efficacy and financial cost of the use of an autologous blood transfusion device in the reduction of allogeneic blood requirements of patients undergoing primary unilateral total knee arthroplasty. Forty-nine consecutive patients received either the CellTrans blood salvage device (group A of 32 patients) or the Redivac high vacuum drainage system (group B of 17 patients). The preoperative and postoperative haemoglobin levels were recorded at 72 or 96 hours. Nine percent of group A patients received an allogeneic blood transfusion compared to 59% in group B. There was an average saving of 1.1 unit of allogeneic blood per patient in group A (p<0.001). The total cost per patient was about Euro 111 less for the group A patients. Autologous re-infusion was found in this study to be an effective method of reducing allogeneic blood requirements and to afford significant cost savings in primary unilateral knee arthroplasty. A controlled, randomized, prospective study was performed evaluating the need for perioperative blood salvage for primary total hip arthroplasty patients who had donated autologous blood before surgery. One hundred fifty-three patients able to donate at least 2 units of autologous blood were divided into four groups. In group 1 (35 patients), intraoperative and postoperative Cell-Saver (Haemonetics, Braintree, MA) was employed. In group 2 (40 patients), a postoperative Solcotrans (Smith & Nephew Richards, Memphis, TN) reinfusion protocol was followed. In group 3 (40 patients), a closed-suction Hemovac drain (Zimmer, Warsaw, IN) was placed. In group 4, (38 patients), no drain was used. Decisions for transfusion were based on clinical and laboratory parameters and made in conjunction with medical consultation. All autologous blood was routinely reinfused. There was no statistically significant difference in transfusion requirements or wound complications among the four groups. Hemoglobin and hematocrit changes between groups also were not statistically significant, but a power test suggested insufficient patient numbers for absolute reliability of this observation. Only five patients (3.3%) in this study received homologous blood. Four of these patients were in the Solcotrans group and one was in the Cell-Saver group. Two reoperations were performed: one for hematoma (Solcotrans group) and one for a sewn-in drain. It is concluded that expensive perioperative blood salvage techniques are usually not needed in patients who have a primary total hip arthroplasty without cement and who have donated 2 units of blood before operation. Postoperative salvage autotransfusion of shed mediastinal blood, using the cardiotomy reservoir, is an inexpensive technique whose efficacy and safety are evaluated in this study. We randomized 75 consecutive patients into two groups. The autotransfusion group (n = 42) received autotransfusion after the completion of the coronary artery bypass grafting (CABG) until the drainage was < or = 50 mL per hour for 2 consecutive hours. The control group (n = 33) was treated with standard chest drainage. Both groups received homologous blood transfusion when the hematocrit fell below 30%. Packed red cells were required post-operatively in 84.8% of the control group and 80.9% of the autotransfusion group (p = NS). Postoperative colloid fluid replacement (excluding autotransfusion fluid) did not differ significantly between the groups. The prothrombin time was significantly higher in the autotransfusion group 24 hours postoperatively (p = 0.03). The fibrin degradation products were elevated only in the serum of the autotransfusion patients (p < 0.002). More febrile patients were seen in the autotransfusion group although not significantly more than the controls. The autotransfusion group received more red cells than the control group, but it lost more red cells in the mediastinal drains. In conclusion, the autotransfusion of shed mediastinal blood has not proved beneficial in reducing the postoperative requirements in homologous blood in patients undergoing coronary artery bypass grafting (CABG). To investigate the effects and safety of autologous peripheral blood stem cell (PBSCs) transplantation by intracoronary infusion in patients with acute myocardial infarction (AMI).
                70 patients with AMI were allocated to two groups, one was PBSCs transplantation group (n=35) that received optimal post-infarction medical treatment (standard drug and coronary artery intervention therapy) and intracoronary transplantation of PBSCs; the other was control group (n=35) that received optimum post-infarction medical treatment (standard drug and coronary artery intervention therapy). The PBSCs transplantation group received granulocyte colony-stimulating factor (G-CSF: Filgrastim, 300 microg) with the dose of 300-600 microg/day to mobilize the stem cell, and the duration of administration G-CSF was 5 days. On the sixth day, PBSCs were separated by Baxter CS 3000 blood cell separator into suspend liquid 57 ml. Then, the suspend liquid was transferred into the infarct-related artery (IRA) by occluding the over-the-wire balloon and infusing artery through balloon center lumen. In the process of the mobilization, separation and intracoronary infusion of PBSCs, the complications have been investigated. Changes in left ventricular function were assessed at 6-month follow-up.
                35 cases had finished follow-up in the treated group, while 23 cases in control group. After 6 months, within the treated group, there was a significant improvement in global left ventricular function ejection fraction (EF) from a baseline of 50.0+/-8.2% to 57.1+/-7.8% (P<0.0001), wall motion score index (WMSI) from 1.219+/-0.190 to 1.101+/-0.118 (P<0.0001), left end-systolic volume (ESV) from 63.8+/-23.9 ml to 52.6+/-20.3 ml (P=0.01) and left end-diastolic volume (EDV) from 134.2+/-36.7 ml to 119.2+/-30.3 ml (P=0.07); in the control group, there was no significant improvement in EF, WISM, EDV and ESV (P=0.490, 0.259, 0.117, 0.395). After 6-month follow-up, according to treatment group vs. control group, there was a significant improvement in EF from 57.1+/-7.8 to 52.6+/-5.7 (P=0.041) and WISM from 1.101+/-0.118 to 1.184+/-0.138 (P=0.034). There were a total of 25 cases with complications during the mobilization, separating and infusion of PBSC. The incidence of complications relating to mobilization was 37.1% (13/35), relating to separating was 14.3% (5/35) and relating to intracoronary infusion was 20.0% (7/35). No death was observed.
                Autologous PBSCs transplantation by intracoronary infusion is feasible and safe, and it can improve left ventricular function in the 6-month follow-up. We sought to assess the efficacy of preoperative autologous blood donation in reducing patient exposure to allogeneic blood products following elective cardiac surgery.
                We included 48 patients in a prospective study and randomly assigned them into the control or treatment group. We excluded patients with aortic stenosis, main trunk stenosis and unstable angina. Group A (n=23; coronary disease n=21 and valvular disease n=2) was the control group, and group B (n=25; coronary disease n=21, valvular disease n=4) received preoperative autologous blood donation. All patients had cardiopulmonary bypass surgery, and we processed mediastinal blood with a cell-saver device before reinfusion. All patients received aprotinin, and we reinfused blood shed from the mediastinum postoperatively.
                No major peri- or postoperative complications occurred. We interrupted preoperative blood donation in 2 patients (8%) because of worsened angina pectoris. The mean time between the first blood donation and surgery was 22.5 (standard deviation [SD] 9.4, range 12-50) days. In group A, 9 patients (39.1%) were exposed to allogeneic blood products. In group B, 11 patients (47.8%) were exposed to blood products (p=0.73), and 4 (16%) were exposed to allogeneic blood products (p=0.036).
                Preoperative blood donation was completed in 92% of the targeted low-risk population. The procedure significantly reduced exposure to perioperative allogeneic blood products. : Randomized, placebo-controlled trial.
                : To evaluate the efficacy of epsilon aminocaproic acid (EACA) to reduce the number of red-cell (RBC) transfusions in adult patients undergoing major spinal surgery.
                : Reconstructive spinal surgery is associated with significant blood loss. The number of studies evaluating the efficacy of EACA in adult patients undergoing spinal surgery remains scarce and limited.
                : EACA (100 mg/kg) or placebo was administered to 182 adult patients after the induction of anesthesia followed by an infusion that was continued for 8 hours after surgery. Primary end points included total allogeneic RBC transfusions through postoperative day 8 and postoperative allogeneic plus autologus RBC transfusions through postoperative day 8.
                : Mean total allogeneic RBC transfusions were not statistically different between the groups (5.9 units EACA vs. 6.9 units placebo; P = 0.17). Mean postoperative RBC transfusions in the EACA group was less (2.0 units vs. 2.8 units placebo; P = 0.03). There was no significantdifference in mean estimated intraoperative estimated-blood loss (2938 cc EACA vs. 3273 cc placebo; P = 0.32). Mean intensive care unit length of stay was decreased (EACA: 1.8 days vs. 2.8 days placebo; P = 0.04). The incidence of thromboembolic complications was similar (2.2% EACA vs. 6.6% placebo; P = 0.15).
                : The difference in total allogeneic RBC transfusions between the groups was not statistically significant. EACA was associated with a 30% (0.8 units) reduction in postoperative RBC transfusions and a 1-day reduction in ICU LOS, without an increased incidence of thromboembolic events. EACA may be considered for patients undergoing major spinal surgery. Larger studies are needed to evaluate the relationship between EACA and total RBC requirements. The purpose of this study was to attempt to identify a group of patients undergoing infrarenal aortic bypass in whom blood loss is consistently less than 2 units, making the routine use of autotransfusion devices unnecessary.
                Four groups of patients were prospectively studied as follows: abdominal aortic aneurysm (AAA) repair with tube graft (n = 21), AAA repair with bifemoral or biiliac bypass (n = 19), and aortobifemoral bypass (AFB) or biiliac bypass for occlusive disease either with Cell Saver Autotransfusion Device (Haemonetics Corp., Braintree, Mass.) (n = 18) or without Cell Saver (n = 18). The latter two groups were randomized on an alternating basis.
                The following parameters were obtained on all patients: preoperative hemoglobin values, estimated blood loss, Cell Saver return volumes, intraoperative and postoperative homologous blood transfused, postoperative hemoglobin values on the day of surgery and on postoperative days 1 and 4, complications, and length of hospital stay. In comparing the groups undergoing AFB with Cell Saver and AFB without Cell Saver by the above parameters, we found no statistically significant differences, except for a higher hemoglobin level on postoperative day 1 in the group undergoing AFB with Cell Saver (mean 11.86 vs 10.74, p = 0.02). The estimated blood loss and Cell Saver return volumes were less for those patients undergoing AFB for occlusive disease compared with those undergoing AFB for aneurysmal disease. Interestingly, estimated blood loss and Cell Saver return volumes for patients with AAA with tube graft and patients undergoing AFB with Cell Saver were similar.
                We conclude that routine setup and use of rapid autotransfusion devices may not be necessary in every patient undergoing routine aortofemoral bypass for occlusive disease. Furthermore, the possibility that some patients may undergo AAA repair with tube grafts without use of the Cell Saver may be deserving of further investigation. Bleeding and allogeneic transfusion remain constant problems in cardiac surgical procedures. In this study, we aimed to test the role of a routine thromboelastography (TEG)-based algorithm on bleeding and transfusions in patients undergoing elective coronary artery bypass grafting (CABG).
                Patients (n = 224) undergoing elective CABG with cardiopulmonary bypass were prospectively randomized into two groups according to transfusion strategy: in group 1 (clinician-directed transfusion, n = 110) need for blood transfusion was based on clinician's discretion and standard coagulation tests and in group 2 (TEG algorithm group, n = 114) kaolin-activated (k) TEG-based algorithm-guided perioperative transfusion management. Transfusion, blood loss, and outcome data were recorded.
                There were no differences in consumption of packed cell units, blood loss, re-exploration for bleeding, and early clinical outcome between the groups. Patients in the TEG group had significantly lower median units of fresh frozen plasma and platelets compared with the other group (p = 0.001). The median number of total allogeneic units transfused (packed cells and blood products) was significantly reduced in the TEG group compared with the other group (median 2, range 1-3 units vs. median 3, range 2-4 units, respectively, p = 0.001). The need for tranexamic acid was significantly diminished in the TEG group compared with the other group (10.3% vs. 19%, respectively, p = 0.007).
                Our results show that routine use of a kTEG-guided algorithm reduces the consumption of blood products in patients undergoing elective CABG. Adopting such an algorithm into routine management of these patients may help to improve clinical outcome and reduce the potential risks of transfusion-related complications and total costs after CABG. Perioperative red blood cell transfusion is commonly used to address anemia, an independent risk factor for morbidity and mortality after cardiac operations; however, evidence regarding optimal blood transfusion practice in patients undergoing cardiac surgery is lacking.
                To define whether a restrictive perioperative red blood cell transfusion strategy is as safe as a liberal strategy in patients undergoing elective cardiac surgery.
                The Transfusion Requirements After Cardiac Surgery (TRACS) study, a prospective, randomized, controlled clinical noninferiority trial conducted between February 2009 and February 2010 in an intensive care unit at a university hospital cardiac surgery referral center in Brazil. Consecutive adult patients (n = 502) who underwent cardiac surgery with cardiopulmonary bypass were eligible; analysis was by intention-to-treat.
                Patients were randomly assigned to a liberal strategy of blood transfusion (to maintain a hematocrit ≥30%) or to a restrictive strategy (hematocrit ≥24%).
                Composite end point of 30-day all-cause mortality and severe morbidity (cardiogenic shock, acute respiratory distress syndrome, or acute renal injury requiring dialysis or hemofiltration) occurring during the hospital stay. The noninferiority margin was predefined at -8% (ie, 8% minimal clinically important increase in occurrence of the composite end point).
                Hemoglobin concentrations were maintained at a mean of 10.5 g/dL (95% confidence interval [CI], 10.4-10.6) in the liberal-strategy group and 9.1 g/dL (95% CI, 9.0-9.2) in the restrictive-strategy group (P < .001). A total of 198 of 253 patients (78%) in the liberal-strategy group and 118 of 249 (47%) in the restrictive-strategy group received a blood transfusion (P < .001). Occurrence of the primary end point was similar between groups (10% liberal vs 11% restrictive; between-group difference, 1% [95% CI, -6% to 4%]; P = .85). Independent of transfusion strategy, the number of transfused red blood cell units was an independent risk factor for clinical complications or death at 30 days (hazard ratio for each additional unit transfused, 1.2 [95% CI, 1.1-1.4]; P = .002).
                Among patients undergoing cardiac surgery, the use of a restrictive perioperative transfusion strategy compared with a more liberal strategy resulted in noninferior rates of the combined outcome of 30-day all-cause mortality and severe morbidity.
                clinicaltrials.gov Identifier: NCT01021631. Allogeneic blood transfusions have reportedly been associated with a poor prognosis in patients with curatively resected cancer. To control for immunosuppression induced by a speculatively causal allogeneic blood transfusion, we designed a randomized study in which the control group received autologous blood transfusions not related to any condition of immunosuppression.
                One hundred twenty patients with potentially curative resectable colorectal cancer and the capability to predeposit autologous blood were randomly selected to receive either standard allogeneic blood transfusion or predeposited autologous blood.
                In curatively resected cancer patients, the number who needed allogeneic blood transfusions was reduced from 60% in the allogeneic blood group to 33% in the autologous blood group (P = .009). After a median follow-up duration of 22 months (range, 8 to 48) tumor recurrence was observed in 28.9% of the allogeneic blood group and 16.7% of the autologous blood group. Life-table analysis established a tendency toward a shorter tumor-free survival for the allogeneic blood group (log-rank P = .11). The problem with this analysis was the strong association of allogeneic blood transfusions with tumor recurrence, which interfered in 33% of patients in the autologous blood group who required additional allogeneic blood transfusions. Multivariate analysis of established risk factors for tumor recurrence and surgery-related variables reflecting potential immunosuppressive conditions showed that only pT stage (relative risk, 6.61; 95% confidence interval [CI], 1.82 to 23.99; P = .004), pN stage (relative risk, 8.39; 95% CI, 3.15 to 22.33; P < .001), and the need for allogeneic blood (relative risk, 6.18; 95% CI, 2.20 to 17.37; P < .001) were independent predictors of tumor recurrence. Subgroup analysis of patients who received a transfusion of < or = 2 U blood found a significantly higher risk of tumor recurrence in the allogeneic blood group (relative risk, 5.16; 95% CI, 1.13 to 23.62; P = .034), which was reduced to borderline significance (relative risk, 3.54; 95% CI, 0.76 to 16.51; P = .107) by adjustment for tumor (T) and node (N) stage.
                As indicated by these first results, the blood transfusion modality has a significant effect on tumor recurrence after surgical treatment of colorectal cancer. A change in the practice of blood transfusion might thus potentially surpass the impact of any recent adjuvant treatment strategies. The net benefit of routine intraoperative autotransfusion (IAT) in patients undergoing elective infrarenal aortic surgery was studied.
                One hundred patients undergoing abdominal aortic aneurysm (AAA) repair (n = 50) or aortofemoral bypass (AFB) for occlusive disease (n = 50) were randomized to IAT and control groups. This experience accounted for 58% of patients undergoing aortic surgery during the 16-month study period.
                IAT and control groups were balanced for preoperative demographics, disease (50:50 split of AFB:AAA in each group), and risk factors. There were no significant differences between patients randomized to IAT and control patients in estimated blood loss (EBL), allogeneic blood transfusion (units administered intraoperatively, postoperatively, and total), proportion of patients not receiving allogeneic blood (34% of patients randomized to IAT and 28% of control patients), postoperative hemoglobin/hematocrit levels, and complications. IAT did not reduce allogeneic blood transfusion among all patients undergoing aortic surgery nor in any subgroups that might be more likely to benefit, such as those undergoing AAA repair, those with 1000 mL or more EBL, and those receiving larger volumes of IAT-processed blood.
                We could find no net benefit of IAT in patients undergoing elective, infrarenal aortic surgery. We evaluated the blood conservation effects of tranexamic acid (TA) or aprotinin administered before and during cardiopulmonary bypass (CPB) in a prospective, randomized, double-blind study of 150 adult patients undergoing primary coronary artery bypass grafting surgery. Patients received either TA (2 g) or large-dose aprotinin (7 million KIU). Thirty additional untreated patients otherwise managed in a similar fashion were included from a recently completed study for comparison of outcomes. Demographic, medical, surgical, laboratory, mediastinal chest tube drainage (MCTD), transfusion, and outcome data were collected. Allogeneic blood product administration was tightly controlled. The demographic, medical, and surgical characteristics did not significantly differ between the two therapy groups. The median postoperative MCTD loss in the TA group did not significantly differ from that in the aprotinin-treated group (708 vs 600 mL). The percentage of patients that received no allogeneic blood products was 25% for the TA group and 27% for the aprotinin group (P = not significant). The median number of allogeneic blood products administered to the TA group (0 U) did not significantly differ from that administered to the aprotinin group (0 U). The percentage of patients with excessive MCTD (>1000 mL/24 h) did not significantly differ between groups (19% and 17%, respectively). In comparison, the control group had a significantly greater (P < 0.05) median MCTD (1020 mL), median allogeneic blood product exposure (4.5 U), and incidence of excessive MCTD (66%) and transfusion therapy (66%). These data help to support the use of pharmacologic methods to improve clinically relevant indicators of blood conservation for primary CPB procedures. Furthermore, the data show that TA is equivalent to aprotinin for blood conservation in patients at risk of excessive post-CPB bleeding and transfusion therapy. Implications: In a randomized, blind trial, we evaluated the effects of tranexamic acid or aprotinin on blood conservation after primary cardiopulmonary bypass surgery. Both drugs were equally effective in reducing blood loss, the incidence of transfusion, and the amount of blood products transfused compared with placebon. An international collaboration was set up to prospectively evaluate the role of allogeneic transplantation for adults with acute lymphoblastic leukemia (ALL) and compare autologous transplantation with standard chemotherapy. Patients received 2 phases of induction and, if in remission, were assigned to allogeneic transplantation if they had a compatible sibling donor. Other patients were randomized to chemotherapy for 2.5 years versus an autologous transplantation. A donor versus no-donor analysis showed that Philadelphia chromosome-negative patients with a donor had a 5-year improved overall survival (OS), 53% versus 45% (P = .01), and the relapse rate was significantly lower (P < or = .001). The survival difference was significant in standard-risk patients, but not in high-risk patients with a high nonrelapse mortality rate in the high-risk donor group. Patients randomized to chemotherapy had a higher 5-year OS (46%) than those randomized to autologous transplantation (37%; P = .03). Matched related allogeneic transplantations for ALL in first complete remission provide the most potent antileukemic therapy and considerable survival benefit for standard-risk patients. However, the transplantation-related mortality for high-risk older patients was unacceptably high and abrogated the reduction in relapse risk. There is no evidence that a single autologous transplantation can replace consolidation/maintenance in any risk group. This study is registered at http://clinicaltrials.gov as NCT00002514. A pilot study evaluated the effectiveness of Vivostat patient-derived fibrin sealant in reducing blood loss in patients who underwent primary hip arthroplasty. Eighty adult patients undergoing elective surgery were randomized to receive either Vivostat sealant or control (no additional hemostatic treatment). Patients allocated Vivostat sealant donated 120 mL of blood, which was then processed perioperatively to produce a fibrin sealant that was applied to the bleeding wound surfaces just before closure. Transfusion requirements, blood loss during surgery, drain volumes, and daily hematocrit and hemoglobin levels were measured. Hospitalization times, adverse events, and postoperative wound complications were also monitored. Blood loss during surgery and wound drainage volume was lower in the Vivostat group than in the control group, although the differences were not significantly different. Transfusion requirements (median, 270 mL of packed red blood cells) and hospitalization times (both median 7 days) were the same for both groups. No adverse events related to the use of Vivostat occurred. There were indications of a possible reduction in the incidence of postoperative wound oozing (15% vs 25%) and hematomas (6% vs 11%) with the use of Vivostat compared with the control group, although differences were not statistically significant. In conclusion, in this pilot study, use of Vivostat patient-derived fibrin in hip arthroplasty was not associated with a significant reduction in blood loss. Further studies, with larger numbers of patients, may be warranted to investigate a possible benefit of Vivostat in reducing postoperative wound complications. Anemia may be an important factor contributing to an increased risk of bleeding, particularly in patients with thrombocytopenia.
                A multicenter, single-blinded pilot randomized controlled trial (RCT) was performed to evaluate the feasibility of conducting a larger RCT to determine the effect of the hemoglobin (Hb) concentration on bleeding risk. Patients with acute leukemia receiving induction chemotherapy or those undergoing stem cell transplantation were assigned to one of two treatment groups: standard transfusion strategy (transfusion of 2 units of red blood cells [RBCs] when their Hb level was less than 80 g/L) or an augmented transfusion strategy (transfusion of 2 units of RBCs when their Hb level was less than 120 g/L).
                Sixty patients were enrolled: 29 in the control group and 31 in the experimental group. The proportions of patients experiencing clinically significant bleeding and the time to first bleed were not significantly different between the control and experimental groups. The experimental group received more RBC transfusions (transfusions/patient-day) than the control group (0.233 vs. 0.151; relative risk, 1.56; 95% confidence interval, 1.16-2.10; p = 0.003). The proportion of patient-days with platelet (PLT) transfusions was not different between the experimental and control groups. The mean number of donor exposures (PLT and RBC transfusions) was not different between experimental and control groups. Bleeding symptoms were systematically documented.
                This pilot study thus indicated that it would be feasible to enroll the required number of patients to enable the performance of a large RCT to investigate the effect of Hb on bleeding risk in thrombocytopenic patients. Autologous shed blood for autotransfusion was evaluated at four medical centers in a prospective randomized study. One hundred twenty-eight patients were studied after hip replacement, knee replacement, or spine fusion. The efficacy of autologous shed blood in reducing homologous transfusion was evaluated. The relative risk of transfusion with homologous blood was 0.4 in patients who received shed blood compared with patients who did not receive shed blood. The reinfusion of shed blood reduced the requirement for homologous blood by 60%. Two filter systems were evaluated in reinfusing autologous shed blood. The Pall RC100 filter appeared to be more effective than the Pall 40-mu screen filter in removing fat particles and white blood cells. No significant clinical abnormalities were discovered after autotransfusion with autologous shed blood. Evaluation of clotting studies showed no significant differences between patients who received shed blood and patients who received liquid-preserved red blood cells. These data indicate that unwashed autologous shed blood from orthopaedic wound drainage is a safe and effective substitute for transfusion of autologous predonated blood or homologous liquid-preserved red blood cells. Activated recombinant coagulation factor VII (rFVIIa) effectively prevents and controls bleeding in patients with coagulopathy. Data show that rFVIIa may reduce blood loss and eliminate the need for transfusion in patients with normal haemostasis undergoing major surgery. We assessed the efficacy of rFVIIa in patients with normal haemostasis undergoing repair surgery of major traumatic fracture of the pelvis or the pelvis and acetabulum, who were expected to have a large volume of blood loss.
                We performed a double-blind, randomized, placebo-controlled trial involving 48 patients undergoing major pelvic-acetabular surgery. Patients were randomized to receive an i.v. bolus injection of rFVIIa 90 microg kg(-1) or placebo as add-on therapy at the time of the first skin incision. All patients also received intraoperative salvaged red blood cells (RBC).
                There was no significant difference in the total volume of perioperative blood loss, the primary outcome variable, between the rFVIIa and placebo groups. In addition, there were no differences between the two groups in the total volume of blood components, including salvaged RBC transfused, number of patients requiring allogeneic blood components, total volume of fluids infused, total operating time, time taken after entry to the intensive care unit to reach normal body temperature and acid-base status, and time spent in hospital. No adverse events, in particular thromboembolic events, were reported in either group.
                In patients with normal haemostasis undergoing repair surgery of traumatic pelvic-acetabular fracture, the prophylactic use of rFVIIa does not decrease the volume of perioperative blood loss. This prospective study was designed to determine whether use of nonwashed shed mediastinal blood exacerbated platelet and related hematologic dysfunctions after cardiopulmonary bypass, compared with the alternative use of autologous and homologous standard liquid preserved blood for volume support. Thirty-two patients undergoing cardiopulmonary bypass for open heart operations were randomized to receive either nonwashed shed mediastinal blood (group 1; n = 16) or liquid preserved packed red blood cells (group 2; n = 16) for transfusion therapy in the management of postoperative bleeding. Patient blood samples and bleeding times were obtained preoperatively, after cardiopulmonary bypass but before transfusions, 2 and 24 hours after transfusion, and on postoperative days 2, 3, and 7. Group 1 patients received an average of 710 +/- 90 mL (range, 300 to 1,700 mL) of nonwashed shed mediastinal blood containing significantly greater (p < 0.0001) amounts of fibrin degradation products and D-dimer protein. Of the hematologic, microaggregate, and plasma protein measurements performed, only the protein C level was significantly greater in group 1 (p < 0.05) after transfusion. Patient bleeding times were not significantly different between the groups at any of the time points, and the total postoperative blood loss was not different between the groups. There was a trend toward less need for homologous transfusion in group 1 (p < 0.1). This study documents the safety and ease of using nonwashed shed mediastinal blood as a primary blood volume support after an open heart operation. We performed a prospective, randomized study to determine the effect of postoperative collection and reinfusion of unwashed, filtered, salvaged blood on the transfusion requirements of 232 patients managed with a total hip replacement. Patients who were scheduled to have a primary or revision procedure were advised to predeposit two or four units of autologous blood, respectively, before the operation. In addition, intraoperative blood salvage was performed for all patients who had a revision procedure. The patients were randomly assigned to one of two groups: the first group was managed with postoperative blood salvage with use of the Autovac Postoperative Orthopaedic Autotransfusion Canister and the second, with closed suction drainage with use of the Hemovac system. In the first group, blood was collected from wound drains for four hours postoperatively; if at least 300 milliliters of blood was collected, the unwashed blood was reinfused through a microaggregate filter during a two-hour period. A maximum of 1000 milliliters of salvaged blood was reinfused; any blood that had not been reinfused within six hours after the beginning of collection was discarded. No complications or episodes of hypotension, confusion, cardiac or pulmonary compromise, febrile reaction, or coagulopathy were observed during or after the reinfusion of the unwashed, filtered, salvaged blood. No reinfusions were interrupted or discontinued. We found that postoperative reinfusion of unwashed, filtered, salvaged blood was associated with a decreased prevalence of homologous transfusion after a total hip replacement among patients for whom preoperatively donated autologous blood was not available.(ABSTRACT TRUNCATED AT 250 WORDS) Because of allogenic red blood cell (RBC) availability and infection problems, novel alternatives, including hemoglobin-based oxygen-carrying solutions (HBOC), are being explored to minimize the perioperative requirement of RBC transfusions. This study evaluated HBOC-201, a room-temperature stable, polymerized, bovine-HBOC, as a substitute for allogenic RBC transfusion in patients undergoing elective infrarenal aortic operations.
                In a single blind, multicenter trial, 72 patients were prospectively randomized two-to-one to HBOC (n = 48) or allogenic RBC (n = 24) at the time of the first transfusion decision, either during or after elective infrarenal aortic reconstruction. Patients randomized to the HBOC group received 60 g of HBOC for the initial transfusion and had the option to receive three more doses (30 g each) within 96 hours. In this group, any further blood requirement was met with allogenic RBCs. Patients randomized to the allogenic RBC group received only standard RBC transfusions. The efficacy analysis was a means of assessing the ability of HBOC to eliminate the requirement for any allogenic RBC transfusions from the time of randomization through 28 days. Safety was evaluated by means of standard clinical trial methods.
                The two treatment groups were comparable for all baseline characteristics. Although all patients in the allogenic RBC group required at least one allogenic RBC transfusion, 13 of 48 patients (27%; 95% CI, 15% to 42%) in the HBOC group did not require any allogenic RBC transfusions. The only significant changes documented were a 15% increase in mean arterial pressure and a three-fold peak increase in serum urea nitrogen concentration after HBOC. The complications were similar in both groups, with no allergic reactions. There were two perioperative deaths (8%) in the allogenic RBC group and three perioperative deaths (6%) in the HBOC group (P = 1.0).
                HBOC significantly eliminated the need for any allogenic RBC transfusion in 27% of patients undergoing infrarenal aortic reconstruction, but did not reduce the median allogenic RBC requirement. HBOC transfusion was well tolerated and did not influence morbidity or mortality rates. In a prospective randomized double-blind placebo-controlled trial, the effect of rh-SOD, given in a dose of 200 mg intravenously during surgery to cyclosporine-treated recipients of cadaveric renal allografts, on both acute and chronic rejection events as well as patient and graft survival was investigated by analyzing the patients' charts retrospectively. The results obtained show that rh-SOD exerts a beneficial effect on acute rejection events as indicated by a significant reduction of (1) first acute rejection episodes from 33.3% in controls to 18.5%, as well as (2) early irreversible acute rejection from 12.5% in controls to 3.7%. With regard to long-term results, there was a significant improvement of the actual 4-year graft survival rate in rh-SOD-treated patients to 74% (with a projected half-life of 15 years) compared with 52% in controls (with an extrapolated half-life of 5 years). The beneficial effect of rh-SOD observed in this trial is not fully understood, although one can assume that the effect is related to its antioxidant action on ischemia/reperfusion injury of the renal allograft, thereby potentially reducing the immunogenicity of the graft. In addition and in accordance with the "response-to-injury hypothesis" in the pathogenesis of general atherosclerosis, rh-SOD has the potential to mitigate free radical-mediated reperfusion injury-induced acute endothelial cell damage that potentially may contribute to the process of chronic obliterative rejection arteriosclerosis. To study the effectiveness of autotransfusion of shed mediastinal blood in decreasing the need for homologous blood transfusion in the routine cardiac surgical patient, we prospectively randomized 35 consecutive patients into two groups. The experimental group (n = 18) received autotransfusion for 12 hours after completion of the operative procedure. The control group (n = 17) was treated with standard chest drainage and fluid replacement. Both groups received homologous blood transfusion when the hemoglobin level fell to less than 8.0 g/dL. Student's t test, chi 2 analysis, and multivariate logistic regression analysis were used where appropriate. Packed red blood cells were required postoperatively in 6 of the 17 control and 6 of the 18 autotransfusion patients (p = not significant). Postoperative colloid fluid replacement (excluding autotransfusion fluid) in the autotransfusion group (333 +/- 78 mL; 95% confidence bounds, 168 to 498 mL) was less than in the control group (615 +/- 114 mL; 95% confidence bounds, 372 to 857 mL; p = 0.048). Total homologous blood product exposure tended to be higher in autotransfusion patients (83%) than in control patients (47%) (p = 0.057). Fibrin split products were elevated only in the serum of the autotransfusion patients (p < 0.002). No transfusion-related complications were apparent in either group. Although the sample size is small, autotransfusion of shed mediastinal blood does not appear to decrease the need for homologous blood transfusion in the routine cardiac surgical patient. The effect of intraoperative autotransfusion during coronary artery bypass grafting was studied in a randomized double-blind trial involving 38 patients. Nineteen patients had the collected RBCs washed and autotransfused (autotransfusion group), while the remaining patients had their washed cells discarded (control group). Postoperative hemoglobin and hematocrit values were similar. Exposure to banked blood was markedly decreased in the autotransfusion group compared with the control group. In addition, the mean volume of banked packed RBCs transfused per patient was significantly less in the autotransfusion group compared with the control group. Platelet utilization also was markedly decreased in the autotransfusion group. Cryoprecipitate and fresh frozen plasma utilization also was less in the autotransfusion group than in the control group, but this did not reach statistical significance. We conclude that the intraoperative use of autotransfusion decreases the volume of homologous blood products transfused, which results in reduced exposure of the patients to banked blood products. The efficacy of predeposited autologous blood transfusion (PABT) with and without intra/postoperative blood salvage to reduce or eliminate the need for homologous blood transfusion (HBT) in primary total hip or knee replacement surgery was investigated by retrospective and prospective studies. Depending on the type of surgery, one to three units of PABT eliminated the need for HBT in 50 to 78% of patients, but, intra/postoperative blood salvage alone reduced the need only in 11 to 29%. In contrast, blood salvage, when combined with three units of PABT, eliminated the need for HBT in all patients undergoing primary joint replacement surgery. A cost comparison analysis showed that blood salvage was more expensive than PABT, and therefore it should be limited to patients who had predeposited fewer than three units of autologous blood. We undertook a prospective controlled clinical trial of 109 patients to determine whether postoperative blood salvage in patients undergoing total hip or knee arthroplasty decreased the need for transfusion with banked blood. The average amount of blood collected in our series was 493 ml, most of which was collected in the first four postoperative hours. In patients undergoing bilateral total knee arthroplasty, there was a 54% reduction in banked blood utilisation. None of our patients developed adverse effects from the reinfused material. The cost of collecting and processing wound drainage using the Haemolite cell washer was $175 per patient, regardless of the volume processed, compared to $125 for a unit of banked blood. By reducing the requirement for homologous transfusion, blood salvage diminishes the risks of transmission of HIV and hepatitis viruses. In those cases where the equivalent of two units of blood are reinfused, blood salvage saves money. However, due to the small amounts of blood collected in unilateral hip or knee arthroplasty, we do not recommend its routine application in these cases. To evaluate the impact of standard fluid management on the effectiveness of ANH as a blood conservation method in elective open AAA repair.
                Prospective randomised controlled study.
                Thirty-four patients undergoing elective AAA repair were randomised to have ANH (16) or act as controls (18). Intra-operative cell salvage was permitted in both groups. Haemoglobin (Hb) concentrations were determined at variable intervals peri-operatively. Blood loss and the use of heterologous blood were recorded.
                The pre- and post-operative Hb concentrations, surgical blood loss and the use of cell salvage were similar in both groups. Hb concentration (median, range) decreased significantly from pre-operative to aortic clamping (with blood loss <100 ml) in ANH patients from 8.8 (7.5-10.2) to 5.7 (4.2-6.6)mmol/l following ANH but also in controls from 8.6 (7.5-9.7) to 7.0 (4.5-9.0)mmol/l due to fluid infusion (P<0.01 for every comparison). Bank blood requirements were similar: median 2 units in ANH and 2.5 units in control patients (P=0.68).
                Large volumes of fluids infused during AAA repair already conserve blood by the mechanism of hypervolaemic haemodilution. When cell salvage is used with standard fluid management during AAA repair, additional ANH is ineffective in saving blood. In the EORTC ALL-3 trial, the efficacy of allogeneic transplantation was compared with that of autologous marrow transplantation and maintenance chemotherapy in patients <or= 50 years who reached CR.
                Among 340 patients who entered the study, 279 were <or=50 years old. Out of these, 220 reached CR, 184 patients started consolidation and were HLA typed; 68 had a donor and 116 had no sibling donor. The median follow-up was 9.5 years; 93 patients relapsed, 26 died in CR, and overall 116 patients died. Allogeneic transplantation was performed in 47 (68%) patients with a donor while autologous transplantation or maintenance chemotherapy was given to 84 (72%) patients without a sibling donor.
                The 6-year disease-free survival rate was similar in the groups with and without donor [38.2% (SE=5.9%) vs. 36.8% (SE=4.6%), hazard ratio 1.01, 95% CI 0.67-1.53]. Comparing the donor group with the no donor group, the former had a lower relapse incidence (38.2% vs. 56.3%, p=0.001), but a higher cumulative incidence of death in CR (23.5% vs. 6.9%, p=0.0004). The 6-year survival rates were similar [41.2% (SE=6.0%) vs. 38.8% (SE=4.6%)].
                This trial did not show that allogeneic transplantation, when a sibling donor is available, produces a better outcome than the policy of offering autotransplantation or chemotherapy in the absence of a donor. To determine if cell-salvaged autologous blood can serve as an alternative to homologous blood, and to examine the incidence of infected complications and length of postoperative stay.
                A prospective randomised study comprising autologous and homologous blood transfusions in patients undergoing elective infrarenal abdominal aortic surgery.
                Fifty patients undergoing AAA surgery were prospectively randomised to homologous blood (n = 27), or autologous blood transfusion (n = 23), using a cell salvage autotransfusion device.
                The haemoglobin at the time of hospital discharge was similar for both groups (11.0 vs. 10.8 g/dl) with no difference in perioperative mortality. The length of stay was reduced in those patients who received autologous blood (9 days vs. 12 days, p < 0.05 Mann-Whitney U test). There were four infected cases in the autologous group and 12 in the homologous group (p = n.s., Fisher's exact probability test). However, patients who received 3-4 units of homologous blood had an increased risk of infection compared to those who received a similar amount of autologous blood (50% vs. 0%).
                Cell salvage autologous blood can safely replace, or at least decrease, exposure to homologous blood transfusion, with a reduction in the mean hospital stay. Antifibrinolytics are widely used in cardiac surgery to reduce bleeding. Allogeneic blood transfusion, even in primary cardiac operations with low blood loss, is still high. In the present study we evaluated the impact of tranexamic acid compared to aprotinin on the transfusion incidence in cardiac surgical patients with low risk of bleeding.
                This prospective, randomized, double-blind study included 220 patients undergoing primary coronary artery revascularization (coronary artery bypass grafting [CABG]) or aortic valve replacement (AVR). Randomized in blocks of 20, patients received either tranexamic acid (approximately 6 g) or full-dose aprotinin (approximately 5-6 x 10(6) Kallikrein Inhibiting Units). Transfusion was guided by a strict transfusion algorithm. Molecular markers of hemostasis were determined to assess differences in the mode of action of the two drugs. Primary end-points were the incidence of allogeneic red cell transfusion and 24-h postoperative blood loss. Data were analyzed according to the intention-to-treat principle and compared using the chi(2) and Mann-Whitney U-test.
                Two-hundred-twenty patients were enrolled (CABG: 134, AVR: 86). In the aprotinin Group 47% of patients received allogeneic blood during the hospital stay as compared to 61% in the tranexamic acid group (P = 0.036). Aprotinin conferred a 23% reduction in allogeneic transfusion risk (RR 0.77, 95% CI 0.53-0.88). Overall, no significant difference in postoperative bleeding was observed, although 24-h blood loss was reduced in aprotinin-treated CABG patients (500, 350-750 mL vs 650, 475-875 mL (median, 25th-75th percentile); P = 0.039). Despite the lower transfusion rate, the hemoglobin concentration on the first postoperative day was higher in the aprotinin group (11.3, 9.9-12.1 vs 10.6, 9.9-11.6 mg/dL; P = 0.023). The fibrinolytic activity at the end of operation determined by D-Dimer was comparable in both groups. (0.15, 0.11-0.17 mg/L [aprotinin] versus 0.18, 0.12-0.24 mg/L [tranexamic acid]). The activated partial thromboplastin time was prolonged up to 4 h postoperatively in the aprotinin group, while the heparin requirement was reduced: 19% of the patients in the aprotinin group and 45% in the tranexamic acid group received at least one additional bolus heparin during cardiopulmonary bypass (P < 0.001). Troponin T levels postoperatively and on postoperative day 1 were significantly higher in the tranexamic acid group (P = 0.017). No differences in renal, cardiac, or mortality outcomes were observed.
                Considering the rate of transfusion of red blood cells, tranexamic acid was slightly inferior in patients undergoing CABG, but there was no difference in patients receiving AVR. Tranexamic acid seems to be less effective in operations with increased bleeding such as CABG. Clinical benefit depends on specific patient and institution characteristics (ClinicalTrials.gov NCT00396760). The efficacy of a postoperative blood salvage system was assessed in 239 consecutive patients undergoing total knee or total hip arthroplasty. Patients were randomly allocated to either a control group using a standard drainage system or to the study group using the Solcotrans blood salvage canister. The median amount of homologous blood required after operation by the study group was reduced by 74% from the amount required by the control group (mean, 67 ml vs 256 ml, respectively; P less than .0001). Thirteen percent (13%) of the study group required postoperative homologous blood transfusions, as compared to 39% of the control group (P less than .0001). Additionally, patients in the study group had higher hemoglobin levels beginning on the first postoperative day. This study indicates that a postoperative blood salvage system safely and effectively reduces the amount of homologous blood required and sustains higher hemoglobin levels after operation. High-dose aprotinin is an effective but costly method to reduce transfusions after cardiopulmonary bypass (CPB). Very low doses of aprotinin have been shown to be effective in primary cardiac surgery, but not in patients undergoing procedures associated with the greatest usage of allogeneic blood products after CPB. We evaluated the efficacy of ultra-low-dose aprotinin in this patient population.
                Aprotinin 1 million KIU or placebo was added to the priming solution of the CPB circuit of 52 patients undergoing a reoperation and/or a complex surgical procedure. Dryness of operative field, hemoglobin concentrations, coagulation parameters, chest drainage, and transfusion requirements were compared.
                Total chest drainage was not different between groups, but fewer patients in the aprotinin group required additional protamine postoperatively (35% vs 69% for controls, p = 0.03) and fewer received fresh frozen plasma (FFP; 19% vs 46% for controls, p = 0.04). Red cell transfusion was smaller in the aprotinin group compared to placebo (median 4 and 2 units, respectively, p = 0.04). Transfusion of FFP, platelets, cryoprecipitates was not different between groups. Total number of units transfused tended to be reduced in the aprotinin group compared to control (median 2 and 7 units, respectively, p = 0.06).
                Prophylactic administration of ultra-low-dose aprotinin reduced transfusions in patients undergoing repeat operations or complex procedures. Aprotinin could be used in a more economical manner, even in this patient population at high-risk of receiving allogeneic blood products. To determine whether brief, face-to-face educational outreach visits can improve the appropriateness of blood product utilization.
                Randomized, controlled multicenter trial with 6-month follow-up.
                Surgical and medical services of two pairs of matched community and teaching hospitals in Massachusetts.
                One hundred one transfusing staff surgeons and attending medical physicians.
                A professionally based transfusion specialist presented one surgical- or medical-service-wide lecture emphasizing appropriate indications, risks, and benefits of red blood cell transfusions; brief, graphic, printed educational guidelines; and one 30-minute visit with each transfusing physician. No data feedback was provided. Educational messages emphasized the lack of utility of the traditional threshold for red blood cell transfusions (hematocrit, 30%) and transfusion risks (eg, viral hepatitis).
                Proportion of red blood cell transfusions classified as compliant or noncompliant with blood transfusion guidelines, or indeterminate 6 months before and 6 months after an experimental educational intervention.
                Based on analyses of 1449 medical record audits of red blood cell transfusions that occurred 6 months before and 6 months after the educational intervention, the average proportion of transfusions not in compliance with criteria declined from 0.40 to 0.24 among study surgeons (-40%) compared with an increase from 0.40 to 0.44 (+9%) among control surgeons (P = .006). These effects were consistent across procedure type and specialty. On average, study surgeons in the postintervention period performed transfusions when hematocrits were 2.0 percentage points lower than before the intervention (28.3% preintervention vs 26.3% postintervention), and lower than in the control group (28.3% preintervention and postintervention; P = .04). Likely savings in blood use for surgical services probably exceeded program costs, even without considering reduced risks of infection. No effects were observed among transfusions occurring in medical services, possibly because of substantially lower transfusion rates and lower pretransfusion hematocrits.
                Brief, focused educational outreach visits by transfusion specialists can substantially improve the appropriateness and cost-effectiveness of blood product use in surgery. More data are needed regarding the durability of changes in practice patterns and the health and economic benefits of such interventions. Platelet-rich plasma (PRP) is postulated to decrease postoperative mediastinal chest tube drainage (MCTD) and allogeneic blood transfusions (ABT) after surgery with cardiopulmonary bypass. However, recent metaanalysis of the literature reveals that few good quality (therapeutic yield) trials that show a benefit have been published. The potential hemodynamic instability caused by plateletpheresis has not been emphasized. We studied the effect of plateletpheresis on MCTD, ABT, and hemodynamic stability in reoperative coronary artery bypass graft patients, a group perceived to be at high risk for ABT. Ninety patients were randomly assigned to Pheresis or Control groups. epsilon-Aminocaproic acid was given to all patients. Hemodynamic instability was assessed by degree of volume and inotrope resuscitation required. Part of the sequestered platelet volume was used to make autologous platelet gel, which was applied as a wound sealant. Mean pheresis yield was 30% +/- 7% of the circulating platelet mass or 6.4 +/- 2.2 allogeneic platelet unit equivalents. Total MCTD did not differ between the groups. There were no differences in mean packed red blood cell, platelet, and plasma transfusion rates. Overall, 52% of the Pheresis group received ABT, versus 55% of the Control group. Fifty-three percent of the Pheresis group patients exhibited significant hemodynamic instability, versus 27% of the Control group (P < 0.05). This study was unable to show any reduction in MCTD or ABT, although the plateletpheresis technique may offset platelet dysfunction caused by aspirin or increased blood exposure to nonbiologic surfaces, or it may compensate for lack of antifibrinolytic use. The significantly increased incidence of hemodynamic instability in the Pheresis group means that the risk/benefit ratio must be determined for individual cardiac surgical units. The efficacy of four different blood conservation techniques in decreasing the homologous blood requirement in cardiac operations was studied prospectively in 100 patients undergoing myocardial revascularization. The patients were randomly assigned to four groups of 25 each as follows: group I, retransfusion of oxygenator blood after termination of extracorporeal circulation; group II, processing of oxygenator content by means of a cell separator; group III, predonation of autologous blood and isovolumetric substitution of hydroxyethyl starch (10 ml/kg bodyweight) after the induction of anesthesia in addition to the use of a cell separator; and group IV, predonation and the use of a cell separator plus postoperative retransfusion of shed mediastinal blood. To form homologous groups, we accepted only male patients without impairment of left ventricular function for the study. In addition, patients with internal mammary artery grafts and a duration of extracorporeal circulation less than 45 minutes or more than 90 minutes were excluded. The bank blood requirement during hospitalization was 2132 +/- 824 ml in group I, 1371 +/- 928 ml in group II, 833 +/- 599 ml in group III, and 408 +/- 559 ml in group IV. The use of blood conservation techniques resulted in reductions of homologous blood requirements of 34%, 60%, and 80%, respectively, in groups II to IV as compared with the requirement in group I. There were no complications related to autologous blood transfusion. We conclude that the use of blood conservation techniques can considerably reduce the homologous blood requirement in cardiac operations and therefore decrease transfusion-related risks. In elective orthopaedic hip- and knee replacement surgery patients, we studied the effect of implementation of a uniform transfusion policy on RBC usage.
                A randomized, controlled study. A new uniform, restrictive transfusion policy was compared with standard care, which varied among the three participating hospitals. Only prestorage leucocyte-depleted RBC(s) were used. Primary end-point was RBC usage, related to length of hospital stay. Secondary end-points were Hb levels, mobilization delay and postoperative complications.
                Six hundred and three patients were evaluated. Adherence to the protocol was over 95%. Overall mean RBC usage was 0.78 U/patient in the new policy group and 0.86 U/patient in the standard care policy group (mean difference 0.08;95% CI [-0.3; 0.2]; P = 0.53). In two hospitals, the new transfusion policy resulted in a RBC reduction of 30% (0.58U RBC/patient) (P = 0.17) and 41% (0.29 U RBC/patient) (P = 0.05) respectively. In the third hospital, however, RBC usage increased by 39% (0.31 U RBC/patient) (P = 0.02) with the new policy, due to a more restrictive standard care policy in that hospital. Length of hospital stay was not influenced by either policy.
                Implementation of a uniform transfusion protocol for elective lower joint arthroplasty patients is feasible, but does not always lead to a RBC reduction. Length of hospital stay was not affected. Spinal reconstructive surgery in adults can be associated with significant blood loss, often requiring allogeneic blood transfusion. The objective of this randomized, prospective, double-blind, multicenter study was to evaluate the efficacy of tranexamic acid (TXA) in reducing perioperative blood loss and transfusion in adult patients having elective posterior thoracic/lumbar instrumented spinal fusion surgery.
                One hundred fifty-one adult patients were randomized to receive either a bolus of 10 mg/kg IV of TXA after induction followed by a maintenance infusion of 1 mg/kg/hr of TXA, or an equivalent volume of placebo (normal saline). The primary outcome was the total perioperative estimated and calculated blood loss intraoperatively and 24 h postoperatively. Secondary outcomes were incidence of allogeneic blood exposure, and duration of hospital stay.
                Four patients were withdrawn for identifiable surgical bleeding, therefore 147 patients were included in the analysis. The total estimated and calculated perioperative blood loss was approximately 25% and 30% lower in patients given TXA versus placebo (1592 +/- 1315 mL vs 2138 +/- 1607 mL, P = 0.026; 3079 +/- 2558 vs 4363 +/- 3030, P = 0.017), respectively. There was no difference in the amounts of blood products transfused, and length of stay between the two groups. TXA, surgical duration, and number of vertebrae fused were independent factors related to perioperative blood loss. Predictors for the need for allogeneic red blood cell transfusion were ASA classification, surgical duration and number of levels fused.
                TXA significantly reduced the estimated and calculated total amount of perioperative blood loss in adult patients having elective posterior thoracic/lumbar instrumented spinal fusion surgery. Previous reports have suggested that the use of recombinant human erythropoietin is effective for decreasing the need for perioperative allogeneic blood transfusion. The purpose of this study was to evaluate the efficacy of erythropoietin in combination with, and compared with, preoperative autologous donation for reducing allogeneic blood requirements for total joint arthroplasty.
                Two hundred and forty patients undergoing primary and revision total hip or knee arthroplasty were enrolled into three groups with different treatment regimens: (1) erythropoietin and preoperative autologous donation (Group 1), (2) erythropoietin alone (Group 2), and (3) preoperative autologous donation alone (Group 3). Patients were evaluated with regard to requirements for allogeneic transfusion, change from the baseline to the lowest postoperative hemoglobin value, postoperative complications, and adverse reactions.
                The rate of allogeneic transfusion was 11% in Group 1 (erythropoietin and preoperative autologous donation) compared with 28% in Group 2 (erythropoietin alone) and 33% in Group 3 (preoperative autologous donation alone). Within Group 1, patients who had a unilateral primary arthroplasty had an allogeneic transfusion rate of 4% and those who had a bilateral or revision arthroplasty had an allogeneic transfusion rate of 17%. In Groups 2 and 3, the allogeneic transfusion rates were 14% and 15%, respectively, for the patients who had a unilateral primary arthroplasty and 35% and 47%, respectively, for those who had a bilateral or revision arthroplasty.
                Preoperative use of erythropoietin in conjunction with preoperative autologous donation reduces the need for allogeneic blood transfusion associated with total joint arthroplasty more effectively than does either erythropoietin or preoperative autologous donation alone. A randomized controlled trial was conducted to clarify the effectiveness of intraoperative blood salvage in reducing blood loss.
                Although reduction of central venous pressure (CVP) is thought to decrease blood loss during liver resection, no consistently effective and safe method for obtaining the desired reduction of CVP has been established.
                Living liver donors scheduled to undergo liver graft procurement were randomly assigned to a blood salvage group, in which a blood volume equal to approximately 0.7% of the patient's body weight was collected before the liver transection, or a control group. The surgeons were blinded to the randomization results. The primary outcome measure was blood loss during liver parenchymal division. A multivariate analysis was also performed.
                Seventy-nine donors were allocated intraoperatively to the blood salvage group (n = 40) or the control group (n = 39). The amount of blood loss during liver transection was significantly smaller in the blood salvage group than in the control group (median loss during transection, 140 mL vs. 230 mL, P = 0.034). The CVP at the beginning of the liver parenchymal division was significantly lower in the blood salvage group than in the control group (median, 5 cm H2O vs. 6 cm H2O, P = 0.005). The results of a multivariate analysis revealed that intraoperative blood salvage offered the advantage of reduced blood loss during liver parenchymal division (adjusted OR, 0.31; 95% CI, 0.11-0.85, P = 0.025).
                Modest intraoperative blood salvage significantly and safely reduced blood loss during hepatic parenchymal transection. Transfusion therapy after cardiac surgery is empirically guided, partly due to a lack of specific point-of-care hemostasis monitors. In a randomized, blinded, prospective trial, we studied cardiac surgical patients at moderate to high risk of transfusion. Patients were randomly assigned to either a thromboelastography (TEG)-guided transfusion algorithm (n = 53) or routine transfusion therapy (n = 52) for intervention after cardiopulmonary bypass. Coagulation tests, TEG variables, mediastinal tube drainage, and transfusions were compared at multiple time points. There were no demographic or hemostatic test result differences between groups, and all patients were given prophylactic antifibrinolytic therapy. Intraoperative transfusion rates did not differ, but there were significantly fewer postoperative and total transfusions in the TEG group. The proportion of patients receiving fresh-frozen plasma (FFP) was 4 of 53 in the TEG group compared with 16 of 52 in the control group (P < 0.002). Patients receiving platelets were 7 of 53 in the TEG group compared with 15 of 52 in the control group (P < 0.05). Patients in the TEG group also received less volume of FFP (36 +/- 142 vs 217 +/- 463 mL; P < 0.04). Mediastinal tube drainage was not statistically different 6, 12, or 24 h postoperatively. Point-of-care coagulation monitoring using TEG resulted in fewer transfusions in the postoperative period. We conclude that the reduction in transfusions may have been due to improved hemostasis in these patients who had earlier and specific identification of the hemostasis abnormality and thus received more appropriate intraoperative transfusion therapy. These data support the use of TEG in an algorithm to guide transfusion therapy in complex cardiac surgery. Implications: Transfusion of allogeneic blood products is common during complex cardiac surgical procedures. In a prospective, randomized trial, we compared a transfusion algorithm using point-of-care coagulation testing with routine laboratory testing, and found the algorithm to be effective in reducing transfusion requirements. While commonly accepted in poor-risk acute lymphoblastic leukemia (ALL), the role of allogeneic hematopoietic stem cell transplantation (allo-SCT) is still disputed in adult patients with standard-risk ALL. We evaluated outcome of patients with ALL in first complete remission (CR1), according to a sibling donor versus no-donor comparison. Eligible patients (433) were entered in 2 consecutive, prospective studies, of whom 288 (67%) were younger than 55 years, in CR1, and eligible to receive consolidation by either an autologous SCT or an allo-SCT. Allo-SCT was performed in 91 of 96 patients with a compatible sibling donor. Cumulative incidences of relapse at 5 years were, respectively, 24 and 55% for patients with a donor versus those without a donor (hazard ratio [HR], 0.37; 0.23-0.60; P < .001). Nonrelapse mortality estimated 16% (+/- 4) at 5 years after allo-SCT. As a result, disease-free survival (DFS) at 5 years was significantly better in the donor group: 60 versus 42% in the no-donor group (HR: 0.60; 0.41-0.89; P = .01). After risk-group analysis, improved outcome was more pronounced in standard-risk patients with a donor, who experienced an overall survival of 69% at 5 years (P = .05). In conclusion, standard-risk ALL patients with a sibling donor may show favorable survival following SCT, due to both a strong reduction of relapse and a modest nonrelapse mortality. This trial is registered with http://www.trialregister.nl under trial ID NTR228. Transfusing fresh autologous blood during cardiac surgery may improve hemostasis and decrease the need for transfusion.
                A prospective randomized study was performed with fresh whole blood (WB) obtained by intraoperative hemodilution (IH) and with platelet-rich plasma (PRP) obtained by perioperative apheresis from adult cardiac surgery patients.
                Seventy patients were randomly assigned to three arms: 24 to the PRP arm, 18 to the IH arm, and 28 to serve as controls. A mean of 924 +/- 130 mL of WB was collected from the IH group, and a mean of 650 +/- 124 mL of PRP was collected from the PRP group (mean, 1.42 +/- 0.74 x 10(11) platelets); these components were transfused after bypass. Preoperative measures were similar among groups. Intraoperatively, the groups did not differ in bypass time, estimated blood loss, number of transfusions, or proportion receiving transfusion(s). Postoperatively, control patients had more mediastinal drainage (736 mL vs. 476 mL [IH] and 463 mL [PRP]; p = 0.014), but there was no difference in the proportion of patients requiring red cell transfusion (p = 0.87), the hemoglobin at discharge (p = 0.20), or the length of hospitalization (p = 0.57).
                Although a hemostatic benefit manifested as reduced postoperative bleeding was observed, this study does not support the use of fresh blood components obtained by IH or PRP collection during low-risk cardiac surgery. Additional studies are needed to assess whether more aggressive component collection or the use of these techniques in high-risk cases may have a greater impact on clinical outcome variables, including transfusion. Blood transfusions may adversely affect the prognosis of patients treated surgically for cancer, although definite proof of this adverse effect has not been reported.
                We carried out a randomized trial to investigate whether the prognosis in patients with colorectal cancer would be improved by a program of autologous blood transfusion as compared with the current practice of allogeneic transfusion. Patients in the autologous-transfusion group were required to donate two units of blood before surgery.
                A total of 475 patients were evaluated. We found no significant difference in prognosis between the allogeneic-transfusion group (236 patients) and the autologous-transfusion group (239 patients); colorectal cancer-specific survival rates at four years were 67 percent and 62 percent, respectively (P = 0.39). Among the 423 patients who underwent curative surgery, 66 percent of those in the allogeneic-transfusion group and 63 percent of those in the autologous-transfusion group had no recurrence of colorectal cancer at four years (P = 0.93). We also found that the risk of recurrence was significantly increased in patients who received blood transfusions, either allogeneic or autologous, as compared with patients who did not require transfusions; the relative rates of recurrence were 2.1 (P = 0.01) and 1.8 (P = 0.04), respectively; these rates did not differ significantly from each other.
                The use of autologous blood as compared with allogeneic blood for transfusion does not improve the prognosis in patients with colorectal cancer. Regardless of their type, transfusions are associated with poor prognosis, probably because of the circumstances that necessitate them. Perioperative use of tranexamic acid (TA), a synthetic antifibrinolytic drug, decreases perioperative blood loss, and the proportion of patients receiving blood transfusion in cardiac surgery, but the results may vary in different clinical settings. The primary objective of the present study was to determine the efficacy of TA to decrease chest tube drainage and the proportion of patients requiring perioperative allogeneic transfusions following primary, elective, on-pump coronary artery bypass grafting (CABG) in patients with a low baseline risk of postoperative bleeding.
                In a double-blinded, prospective, placebo-controlled study, 46 patients were randomized into two groups. One group received TA 1.5 g as a bolus, followed by a constant infusion of 200 mg/h until 1.5 g. The other group received placebo (0.9% saline). Among exclusion criteria were treatment with acetylsalicylic acid, non-steroidal anti-inflammatory drugs or other platelet inhibitors within 7 days before surgery.
                Preoperative demographics, biochemical and surgical characteristics were comparable between groups. At 6 h postoperatively, there was a trend towards a greater blood loss (median and interquartile range) in the placebo group (710 and 460-950 ml) compared to the TA group (400 and 350-550 ml), but the difference did not reach statistical significance. Neither were transfusion rates and the amount of autotransfused shed mediastinal blood different between the groups postoperatively. Postoperative d-dimer concentrations were significantly higher in the placebo group compared to the TA group (P < 0.001) This difference could not be explained by differences in the amount of autotransfused shed mediastinal blood alone. Plasma concentrations of beta-thromboglobulin and platelet factor 4 were significantly increased postoperatively in both groups, but without any intergroup differences. Seven patients (15%), one in the TA group and six in the placebo group, were reoperated due to excessive bleeding. Surgical correctable bleeding was found in all except two patients from the placebo group.
                An antifibrinolytic effect following prophylactic use of TA in elective, primary CABG among patients with a low risk of postoperative bleeding, did not result in any significant decrease in postoperative bleeding compared to a placebo group. Off-pump CABG is potentially associated with reduced intraoperative blood loss and homologous blood transfusion in comparison to on-pump CABG. In this randomised controlled study we investigated the effects of autologous cell saver blood transfusion on blood loss and homologous blood transfusion requirements in patients undergoing CABG on- versus off-CPB.
                Eighty patients were randomised into one of four groups: (A) on-CPB with cell saver blood transfusion (CSBT), (B) on-CPB without CSBT, (C) off-pump with CSBT and (D) off-pump without CSBT. Volume of intraoperative autologous blood transfusion, postoperative mediastinal blood loss and homologous blood transfusion requirements were measured. Homologous blood was transfused when haemoglobin concentration fell below 8 g/dl postoperatively. Pre- and postoperatively prothrombin time and partial thromboplastin time were measured.
                Preoperative patient characteristics were well matched among the four groups. The amount of salvaged mediastinal blood available for autologous transfusion was significantly higher in the on-pump group (A) compared to the off-CPB group (C) (433+/-155 ml vs 271+/-144 ml, P=0.001). Volume of homologous blood transfusion was significantly higher in group B vs groups A, C and D (595+/-438 ml vs 179+/-214, 141+/-183 and 230+/-240 ml, respectively, P<0.005). The cell saver groups (A and C) received significantly less homologous blood than the groups without cell saver (160+/-197 ml vs 413+/-394 ml, respectively, P<0.005). Patients undergoing off-CPB surgery received significantly less homologous blood than those undergoing on-CPB CABG irrespective of cell saver blood transfusion (184+/-214 ml vs 382+/-397 ml, P<0.05). Postoperative blood loss was similar in the four groups (842+/-276, 1023+/-291, 869+/-286 and 903+/-315 ml in groups A to D, respectively, P>0.05). Clotting test results revealed no significant difference between the groups. There was no significant difference in postoperative morbidity between groups.
                Off-pump CABG is associated with significant reduction in intraoperative mediastinal blood loss and homologous transfusion requirements. Autologous transfusion of salvaged washed mediastinal blood reduced homologous transfusion significantly in the on-CPB group. Cell saver caused no significant adverse impact on coagulation parameters in on- or off-CPB CABG. Postoperative morbidity and blood loss were not affected by the use of CPB or autologous blood transfusion. We recommend the use of autologous blood transfusion in both on- and off-pump CABG surgery. Autotransfusion of shed mediastinal blood after coronary artery bypass grafting (CABG) has been shown to reduce the requirement for allogeneic blood. We have previously demonstrated in non-randomized studies that the oxygen capacity of shed mediastinal blood is similar to the patient's circulating blood and better than stored allogeneic blood. Therefore, we wanted to examine the influence of autotransfusion of shed mediastinal blood on oxygen transport capacity in patients undergoing CABG.
                A prospective, randomized, controlled study involving 120 patients having elective, uncomplicated CABG was performed. The autotransfusion group received transfusion of shed mediastinal blood for 18 h. Both groups received allogeneic red cells if their hemoglobin concentration decreased below 5 mmol/L. Red blood cell 2,3-diphosphoglycerate (2,3-DPG) was measured preoperatively and at intervals up to the hospital discharged. Hemodynamic measurements as well as blood gas and hemoglobin measurements from samples of arterial and mixed venous blood were used for calculation of oxygen transport capacity.
                During the autotransfusion period only 2 patients (4%) in the autotransfusion group required allogeneic blood compared to 11 patients (20%) in the control group. The 2,3-DPG levels in the autotransfusion group were unchanged before and after autotransfusion (4.4 vs. 4.3 mumol/ml erythrocyte). In the control group, 2,3-DPG levels decreased from 4.3 to 3.9 mumol/ml erythrocyte during the same period. There were no differences in the other measured parameters for oxygen transport capacity between the groups.
                Autotransfusion of shed mediastinal blood conserves the 2,3-DPG level of the red blood cells, while transfusion of stored blood leads to a decrease in 2,3-DPG levels. Autotransfusion had no effect on hemodynamic parameters, oxygen delivery or oxygen extraction. The fate of 248 patients diagnosed of colorectal malignancies between 1973 and 1982 and subjected to radical surgery with curative purposes was analysed. The effect of peroperative whole blood and packed red cells transfusions, along with other co-variants, on the survival of the patients was studied. It was found, by means of the Cox analysis, that whole blood and the Duke's staging system had the most important correlation (p = 0.003 and p = 0.02, respectively) on the patients' prognosis and survival, no such relationship being found with packed red cells transfusion (p = 0.25). Dose-related association between the relapse index and the number of whole blood units transfused was shown by the Mantel's global trend test (p = 0.015). The different effect of the transfusion products would confirm the hypothesis that the relationship between transfusion and poorer prognosis, thought to be due to patient's immunosuppression and hence higher relapse index, could be determined by any ill-defined plasmatic factor. In retrospective studies, perioperative blood transfusions were associated with poor prognosis after surgery for cancer and were a major independent risk factor for postoperative bacterial infection. Leucocyte-depleted, in contrast to buffy-coat-depleted, blood has no immunosuppressive effects in transplantation and so might lack detrimental effects on cancer prognosis and postoperative infections. We studied this hypothesis in a controlled trial by randomly allocating patients to receive either leucocyte-depleted red cells or packed cells without buffy coat when blood was needed. Between 1987 and 1990, 871 eligible patients with colorectal cancer, including 697 patients operated upon with curative intent, were randomised in the 16 participating hospitals. Neither the eligible group nor the curative group showed significant differences between the two trial transfusions in survival, disease-free survival, cancer recurrence rates, or overall infection rates after an average follow-up of 36 months. Patients who had a curative resection and who received blood of any sort had a lower 3-year survival than non-transfused patients (69% vs 81%, p = 0.001) and a higher infection rate (39% vs 24%, p < 0.001). Colorectal cancer recurrence rates, however, were not influenced by blood transfusion (30% vs 26%, p = 0.22). These combined observations confirm the association between blood transfusion and poor patient survival but indicate that the relation is not due to promotion of cancer. Perioperative blood transfusion and subsequent development of postoperative infectious complications may lead to poor prognosis of patients with colorectal cancer. It has been suggested that the development of postoperative infectious complications may be related to the storage time of the transfused blood. Therefore, we studied the relationship between blood storage time and the development of disease recurrence and long-term survival after colorectal cancer surgery.
                Preoperative and postoperative data were prospectively recorded in 740 patients undergoing elective resection for primary colorectal cancer. None of the patients received preoperative or postoperative chemotherapy or radiation therapy. Endpoints were overall survival and disease recurrence in the subgroup of patients operated on with curative intention who also survived the first 30 days after operation. Storage of buffy-coat-depleted red cells suspended in saline, adenine, glucose, and mannitol blood for 21 days was used as cut-off point.
                Median follow-up was 6.8 years (range, 5.4 years to 7.9 years), and median overall survival was 4.6 years for 288 nontransfused patients and 3.0 years for 452 transfused patients (P = 0.004). The survival of patients receiving blood exclusively stored < 21 days was 2.5 years. For patients receiving any blood stored > or = 21 days, survival was 3.7 years (P = 0.12). Among patients with curative resection (n = 532), the hazard ratio of disease recurrence was 1.5 (95 percent CI; 1.1 to 2.2) and 1.0 (95 percent CI; 0.7 to 1.4) in the two transfused groups, respectively, compared with the nontransfused group after multivariable correction for patient age, gender, colonic/rectal tumor localization, Dukes classification, blood loss, and postoperative infectious complications.
                Transfusion of buffy-coat-depleted red cells suspended in saline, adenine, glucose, and mannitol blood stored for < 21 days may be an independent risk factor for development of recurrence after elective colorectal cancer surgery. The purpose of our study was to determine the effectiveness of a postoperative autologous blood reinfusion system as an alternative to homologous, banked blood transfusions in total knee arthroplasty. We carried out a prospective randomised controlled study on 60 patients having unilateral total knee replacements. In all these patients, the same surgical team applied the same surgical technique, and all patients followed the same rehabilitation program. In 30 of these patients (group A), a reinfusion system of unwashed salvaged blood was applied, and they were supplemented postoperatively with banked blood transfusions when required. A control group of 30 patients (group B), in whom standard suction drains were used, received one unit of homologous banked blood transfusion intraoperatively and additional blood transfusions postoperatively when required. The administration of banked blood transfusion was determined by the haemoglobin value (<9 mg/dl) and/or clinical signs (blood pressure, pulse, etc.). The values of haemoglobin, haematocrit and platelets were recorded preoperatively and the first, fifth and 15th postoperative days, respectively. Five patients of group A required nine units of homologous blood (0.3 units/patient) postoperatively. Ten patients of group B required an additional 15 banked blood units postoperatively (in total 45 banked blood units for group B; 1.5 units/patient). In the study group, the total homologous blood requirements were reduced by 80%, while the postoperative blood requirements were reduced by 50%. There was no significant difference in the postoperative haematocrit and haemoglobin values between the two groups. The cost of the blood management in the study group was reduced by 36%. The use of an autologous blood reinfusion system reduces highly effectively the demands of homologous banked blood transfusion in total knee arthroplasty. To assess the application of autologous transplantation of granulocyte colony-stimulating factor (G-CSF)-mobilized peripheral blood mononuclear cells (PBMNCs) in the treatment of critical limb ischemia (CLI) of diabetic patients and to evaluate the safety, efficacy, and feasibility of this novel therapeutic approach.
                Twenty-eight diabetic patients with CLI were enrolled and randomized to either the transplant group or the control group. In the transplant group, the patients received subcutaneous injections of recombinant human G-CSF (600 microg/day) for 5 days to mobilize stem/progenitor cells, and their PBMNCs were collected and transplanted by multiple intramuscular injections into ischemic limbs. All of the patients were followed up after at least 3 months.
                At the end of the 3-month follow-up, the main manifestations, including lower limb pain and ulcers, were significantly improved in the patients of the transplant group. Their laser Doppler blood perfusion of lower limbs increased from 0.44 +/- 0.11 to 0.57 +/- 0.14 perfusion units (P < 0.001). Mean ankle-brachial pressure index increased from 0.50 +/- 0.21 to 0.63 +/- 0.25 (P < 0.001). A total of 14 of 18 limb ulcers (77.8%) of transplanted patients were completely healed after cell transplantation, whereas only 38.9% of limb ulcers (7 of 18) were healed in the control patients (P = 0.016 vs. the transplant group). No adverse effects specifically due to cell transplantation were observed, and no lower limb amputation occurred in the transplanted patients. In contrast, five control patients had to receive a lower limb amputation (P = 0.007, transplant vs. control group). Angiographic scores were significantly improved in the transplant group when compared with the control group (P = 0.003).
                These results provide pilot evidence indicating that the autologous transplantation of G-CSF-mobilized PBMNCs represents a simple, safe, effective, and novel therapeutic approach for diabetic CLI. The objective of this study was to assess the effect of tranexamic acid (TA), a synthetic antifibrinolytic, on blood loss and the need for transfusion of blood products following repeat cardiac valve surgery.
                After ethics committee approval, 41 patients scheduled for reoperative valve replacement were enrolled in this randomized, double blind, placebo controlled study. Patients were randomized to receive TA (10 g in 500 ml NSaline) or placebo (NSaline) as an iv bolus over 30 min, after anaesthesia induction and prior to skin incision. Intraoperative blood loss was assessed by estimating blood volume on drapes, weighing surgical sponges, and measuring suction bottle returns. Postoperative blood loss was measured from mediastinal chest tube drainage following surgery. Blood products were transfused according to a standardized protocol.
                Patient demographics were similar for age, sex, cardiopulmonary bypass pump time, cross clamp time, surgical time, preoperative haemoglobin, coagulation profile, and the number of valves replaced during surgery. Tranexamic acid administration reduced intraoperative blood loss [median (range)] from 1656 (575-6270) to 720 ml (355-5616) (P < 0.01) and postoperative blood loss from 1170 (180-4025) to 538 ml (135-1465) (Intent to Treat n = 41, P < 0.01). The total red blood cells transfused (median, range) was reduced from 1500 (0-9300) ml to 480 (0-2850) ml (P < 0.01) in the TA group. In hospital complications and mortality rates were not reduced in the TA group.
                Tranexamic acid reduced blood loss and the need for blood product transfusion and appears to be an effective treatment for patients undergoing reoperative cardiac valvular surgery.
The results suggest cell salvage is efficacious in reducing the need for allogeneic red cell transfusion in adult elective cardiac and orthopaedic surgery. The use of cell salvage did not appear to impact adversely on clinical outcomes. However, the methodological quality of trials was poor. As the trials were unblinded and lacked adequate concealment of treatment allocation, transfusion practices may have been influenced by knowledge of the patients' treatment status potentially biasing the results in favour of cell salvage.