[The influence of transportation mode on mortality in polytraumatized patients. An analysis based on the German Trauma Registry]. Effects of 2 patterns of prehospital care on the outcome of patients with severe head injury. Impact of helicopter transport and hospital level on mortality of polytrauma patients. Influence of prehospital treatment on the outcome of patients with severe blunt traumatic brain injury: a single-centre study. A multicenter trial for resuscitation of injured patients with 7.5% sodium chloride. The effect of added dextran 70. The Multicenter Group for the Study of Hypertonic Saline in Trauma Patients. Association of direct helicopter versus ground transport and in-hospital mortality in trauma patients: a propensity score analysis. Controlled trials of charcoal hemoperfusion and prognostic factors in fulminant hepatic failure. A randomized trial of comprehensive geriatric assessment in the care of hospitalized patients. Reduced mortality in injured adults transported by helicopter emergency medical services. Efficacy of hetastarch in the resuscitation of patients with multisystem trauma and shock. A randomized trial on the effect of a multimodal intervention on physical capacity, functional performance and quality of life in adult patients undergoing allogeneic SCT. Too little, too late: does tirilazad mesylate reduce fatigue after subarachnoid hemorrhage? Long-term quality of life and hospital mortality in patients treated with intermittent or continuous hemodialysis for acute renal and respiratory failure. Sample size review in a head injury trial with ordered categorical responses. Results of the CONTROL trial: efficacy and safety of recombinant activated Factor VII in the management of refractory traumatic hemorrhage. Prognostic factors to predict outcome following the administration of hypertonic/hyperoncotic solution in hypovolemic patients. A possible association between aprotinin and improved survival after radical surgery for mesothelioma. Plasma infusion for hemolytic-uremic syndrome in children: results of a multicenter controlled trial. Safety and therapeutical benefit of hemicraniectomy combined with mild hypothermia in comparison with hemicraniectomy alone in patients with malignant ischemic stroke. Factors improving survival in multisystem trauma patients. Impact of stereotactic hematoma evacuation on activities of daily living during the chronic period following spontaneous putaminal hemorrhage: a randomized study. Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: The CRYSTMAS study. Air versus ground transport of the major trauma patient: a natural experiment. Pilot-controlled trial of the extracorporeal liver assist device in acute liver failure. Volume therapy in the critically ill: is there a difference?
Thirty years after its introduction in Germany, the benefits of the helicopter emergency medical service (HEMS) compared to ground ambulances (GA) still remain unclear. The aim of this study was to evaluate the influence of helicopter transport on rescue time and mortality based on the data of the German Trauma Registry.
                Data from patients with multiple injuries were documented prospectively between 1993 and 2003 in different trauma centers in Germany, Switzerland, Austria and The Netherlands. From these data, patients with an injury severity score (ISS)<16 were excluded. Patients who were transported to the hospital without a physician were also excluded. The data from included patients were evaluated for time to hospital and influence of transportation service on mortality.
                A total of 7,534 patients with multiple injuries were included. Of these, 3,870 patients were transported by HEMS and 3,664 reached the hospital by GA. There were 74.9% male patients in the HEMS group, and 71.3% male patients in the GA group. The mean ISS was higher in the HEMS group (31.4 vs 30.7; P<0.01); patients transported by GA were older (HEMS: 39.2; NEF:41.3; P<0.01). The GA arrived on the scene after 14.33 min, the HEMS after 18.18 min (P<0.01). Time at the scene was longer in the HEMS group (HEMS: 26:26 min; NEF: 22:29 min; P<0.01). Intubation rate in the HEMS group was about 80%, while patients transported by GA were intubated in 60% of cases. The overall mortality was 30.9%. Evaluation of the TRISS prediction of survival showed a benefit for patients transported with HEMS. In a multivariate analysis, intubated patients with ISS<or=60 had a lower mortality rate if transported with HEMS (NEF: 40.1%; HEMS 34.9%; P<0.01).
                Only minor differences in age and ISS were found between the groups. The time between the accident and arrival of the physician was longer in the HEMS group. The HEMS group also remained on the scene for longer, but had a higher rate of intervention. According to our analysis of the German Trauma Registry, patients with multiple injuries benefit from HEMS transportation. A pattern of prehospital care combining advanced life support, physician staffing, and helicopter transport improves the outcome of patients with severe brain injuries, compared with combined expanded basic life support, nurse staffing, and ground transport.
                Inception cohort from the data set of a population-based, prospective study on major trauma.
                Prehospital and hospital trauma systems of an Italian region.
                All patients with major trauma (Injury Severity Score, >or=16) and severe head injury (Abbreviated Injury Scale score for the head, >or=4) rescued alive from March 1, 1998, to February 28, 1999, who received either form of care. Patients with self-inflicted injuries were excluded. The 184 patients who met the entry criteria were divided equally between care groups.
                None.
                Mortality at 30 days and Glasgow Outcome Scale score of survivors.
                After verifying the comparability of the cohorts, no survival or disability benefit could be demonstrated (95% confidence interval [CI] of the odds ratio for mortality [helicopter/ambulance] [95% CI 1], 0.72 to 2.67; 95% CI of the difference in Glasgow Outcome Scale score medians between helicopter and ambulance groups [95% CI 2], 0.0 to 0.0). Similar results were derived from analyses restricted to the subgroups identified by low (<or=90 mm Hg) roadside systolic blood pressure (95% CI 1, 0.58 to 7.17; 95% CI 2, -1 to 2) and by need for urgent neurosurgical intervention (95% CI 1, 0.16 to 2.60; 95% CI 2, 0 to 2). Exclusion from the ambulance group of victims rescued in urban areas did not change the results (95% CI 1, 0.80 to 3.24; 95% CI 2, 0.0 to 0.0). Stratification by age, Injury Severity Score, and Glasgow Coma Scale score demonstrated a small survival benefit (95% CI 1, 1.12 to 2.12) in the ambulance subgroup with Glasgow Coma Scale score from 10 to 12. Multiple logistic regression analysis confirmed that the group did not affect mortality.
                This study was conceived to emphasize the supposed advantages of the combined helicopter, physician, and advanced life-support rescue. No increased benefit compared with the simpler rescue group could be demonstrated. Despite numerous studies analyzing this topic, specific advantages of helicopter transport of blunt polytrauma patients as compared with ground ambulances have not yet been identified unequivocally.
                Four possible pathways in 403 polytrauma patients (Injury Severity Score [ISS] > 16) who were in reach of the helicopter emergency medical service (HEMS) Dresden were analyzed as follows: HEMS-UNI group (n = 140), transfer by HEMS into a university hospital; AMB-REG group (n = 102), transfer by ground ambulance into a regional (Level II or III) hospital; AMB-UNI group (n = 70), transfer by ground ambulance into the university hospital; and INTER group (n = 91), transfer by ground ambulance into a regional hospital, followed by transfer to the university hospital. Scores used were the ISS and the TRISS. Tests used for statistical analysis included chi2 and Fisher's tests. Statistical significance was set at p > 0.05.
                Age, gender, and mean ISS (range, 33.3-35.6) revealed extensive homogeneity of the groups. Mortality of the AMB-REG group was almost doubled (41.2%) compared with HEMS-UNI (22.1%) patients (p = 0.002). The AMB-UNI group displayed the lowest mortality (15.7%, p = not significant). TRISS analysis (PRE-Chart) revealed identical outcome for AMB-UNI and HEMS-UNI patients. Rescue time averaged 90 +/- 29 minutes for HEMS-UNI patients, 68 +/- 25 minutes for AMB-UNI patients, and 69 +/- 26 minutes for the AMB-REG group.
                Primary transfer by HEMS into a Level I trauma center reduces mortality markedly. In principle, this benefit can be attributed to superior preclinical therapy, primary admission to a Level I trauma center, or both. However, the identical probability of survival of the AMB-UNI and HEMS-UNI groups in this and comparable studies does not confirm generally better survival rates on account of a more aggressive on-site approach. AIM, PATIENTS, AND METHODS: To compare retrospectively the outcomes of patients with severe traumatic brain injury (Injury Severity Score, ISS total >or=15; the Abbreviated ISS-head, aISS(head) >or=9) admitted to our Intensive Care Unit by helicopter (helicopter emergency medical service, HEMS group = 89) with those transported by ambulance (GROUND group = 105) from January 2002 to December 2007.
                The groups were comparable for age, Glasgow Coma Scale, ISS total, and aISS(head). The preadmission time of the HEMS group was significantly longer as compared with the GROUND group, but the interval from admission to definitive care was significantly shorter. In the prehospital phase, HEMS patients were more aggressively treated, as indicated by a significantly greater number of procedures performed (i.e. tracheal intubation and positioning of intravenous lines) and larger volumes of fluids infused. The overall mortality was lower in the HEMS than in the GROUND patients (21 vs. 25% respectively, P<0.05). The survival with or without only minor neurological disabilities was higher in the HEMS than in the GROUND group (54 vs. 44% respectively, P<0.05); among the survivors, the rate of severe neurological disabilities was lower in the HEMS than in the GROUND group (25 vs. 31%, P<0.05).
                In our experience, aggressive early treatment of patients with severe traumatic brain injury was associated with a better outcome likely because of the prevention of secondary brain injury and a shorter interval elapsing from the trauma to definitive care despite more time spent on the scene by the intervening team. To evaluate the use of 250 mL of a 7.5% sodium chloride solution, both with and without added dextran 70, for the prehospital resuscitation of hypotensive trauma patients.
                Double-blind randomized trial.
                Six trauma systems served by helicopter transport.
                Injured patients with systolic blood pressures less than 90 mm Hg at any time in the field or during helicopter transport.
                Infusion of study solution, in the field or during transport, followed by conventional isotonic solutions as needed. Solutions studied in four cohorts were as follows: (1) lactated Ringer's; (2) 7.5% sodium chloride (hypertonic saline); (3) 7.5% sodium chloride combined with 6% dextran 70; and (4) 7.5% sodium chloride combined with 12% dextran 70.
                Blood pressure response; survival to time of hospital discharge among the treatment groups; and survival compared with that predicted by norms from the Major Trauma Outcome Study (MTOS).
                The mean (+/- SD) change in systolic blood pressure on arrival in the emergency department was significantly higher in the hypertonic saline solution group than that in the lactated Ringer's solution group (34 +/- 46 vs 11 +/- 49 mm Hg, P < .03). Overall survival in the four treatment groups was 49%, 60%, 56%, and 45% (not statistically significant). Survival in the hypertonic saline solution group, however, was significantly higher than that predicted by the MTOS norms (60% vs 48%, P < .001). Survival to hospital discharge in patients with baseline Glasgow Coma Scale scores of 8 or less was correlated with treatment group (P < .05 by logistic regression and P < .01 by Cox proportional-hazards analysis; with survival in the hypertonic saline solution group [34%] vs lactated Ringer's solution group [12%]).
                Prehospital infusion of 250 mL of 7.5% sodium chloride is associated with an increase in blood pressure and an increase in survival to hospital discharge compared with survival predicted by the MTOS norms. Patients with low baseline Glasgow Coma Scale scores seem to benefit the most from 7.5% sodium chloride resuscitation. Hypertonic saline solution without added dextran 70 is as effective as the more expensive solutions that contain dextran 70. Helicopter emergency medical services (HEMS) transport of trauma patients has been used for decades. Its use, however, is still a subject of debate, including issues such as high costs, increasing numbers of crashes, and conflicting results regarding effectiveness in reducing mortality. The aim of this study was to examine whether mode of transport (HEMS vs. ground EMS) is independently associated with mortality among trauma patients transported directly from the scene of injury to definitive care.
                All trauma patients transported directly to a Level I or Level II trauma center by either air or ground EMS over a 4-year period were selected from the Oklahoma State Trauma Registry. Multivariable logistic regression was used to develop propensity scores based on variables measured at the scene of injury. The propensity scores represented the predicted probabilities of a patient being transported by HEMS given a specific set of characteristics and were used as a composite confounding variable in subsequent models of the association of mortality and mode of transport. Along with the propensity scores, Injury Severity Scores (ISS), initial Revised Trauma Score (RTS), and distance from the trauma center were included in a Cox proportional hazards model of the association of mode of transport and 24-hour and 2-week mortality.
                Overall, the hazard ratio (HR) for 2-week mortality in patients transported by HEMS was 33% lower (HR = 0.67, 95% confidence interval [CI] = 0.54 to 0.84) than in patients transported by ground EMS from the scene of injury, after adjustment for the propensity score and other covariates. In subanalyses, the apparent association of a reduction in the hazard of early mortality among patients transported by HEMS was most evident for patients with an RTS based on injury scene vital signs of 3 to 7 (HR = 0.61, 95% CI = 0.46 to 0.82). The point estimate of the HR was similar (HR = 0.65 95% CI = 0.34 to 1.2) in the 75% of cases who had normal vital signs at the scene of injury, although it was no longer statistically significant because crude mortality was very low (1.7%) in this group. Among those with a RTS of 3 or less at the scene, crude mortality was 58%, and mode of transport was not associated with mortality (HR = 1.02, 95% CI = 0.68 to 1.6).
                Helicopter EMS transport was associated with a decreased hazard of mortality among certain patients transported from the scene of injury directly to definitive care. Refinements in scene triage and transport guidelines are needed to more effectively select patients that may benefit from HEMS transport from those unlikely to benefit.
                © 2011 by the Society for Academic Emergency Medicine. One hundred thirty-seven patients with fulminant hepatic failure were entered into two controlled trials of charcoal hemoperfusion carried out concurrently. In trial A, 75 patients with grade 3 encephalopathy were randomized to receive 5 or 10 h of hemoperfusion daily. Overall survival rates for the two groups were similar (51.3% vs. 50.0%) as was the frequency of major complications including cerebral edema and renal failure. In trial B, in which 62 patients with established grade 4 encephalopathy on admission were randomized to a no-perfusion group or to have 10 h of hemoperfusion daily, overall survival rates for the two groups were again similar (39.3% and 34.5%, respectively). There was in both trials a significant relationship between survival and etiology quite independent of the use or duration of hemoperfusion. Thus, percentage survival for the acetaminophen-overdose cases was 52.9%, for hepatitis A 66.7%, for hepatitis B 38.9%, for presumed non-A, non-B hepatitis 20%, and for halothane or drug reaction 12.5%. Within the etiologic subgroups survival was also influenced by the three major complications that developed, being inversely related to their frequency and combination, except in the non-A, non-B hepatitis and halothane or drug reaction subgroups, which had a high mortality throughout. In the latter cases particularly, orthotopic liver transplantation merits early consideration and in the group with better "intrinsic" survival (acetaminophen, hepatitis A and B) intensive management of complications (rather than charcoal hemoperfusion) would appear to be of major importance. Although many studies describe benefits from the comprehensive assessment of elderly patients by an interdisciplinary team (comprehensive geriatric assessment), the most supportive evidence for the process has come from programs that rely on specialized inpatient units and long hospital stays. We examined whether an inpatient geriatric consultation service might also be beneficial in a trial involving four medical centers of a group-practice health maintenance organization (HMO).
                We conducted a randomized clinical trial with 2353 hospitalized patients 65 years of age or older in whom at least 1 of 13 screening criteria were present: stroke, immobility, impairment in any basic activity of daily living, malnutrition, incontinence, confusion or dementia, prolonged bed rest, recent falls, depression, social or family problems, an unplanned readmission to the hospital within three months of a previous hospital stay, a new fracture, and age of 80 years or older. Of the 1337 patients assigned to the experimental group, 1261 (94 percent) received a comprehensive geriatric assessment in the form of a consultation, with limited follow-up; the 1016 patients assigned to the control group received usual care. The functional and health status of the patients was measured at base line and 3 and 12 months later; survival was assessed at 12 months. Subgroups of patients who might be presumed to benefit from comprehensive assessment were also studied.
                The survival rate at 12 months was 74 percent in the experimental group and 75 percent in the control group. At base line, 3 months, and 12 months the scores of the two groups on measures of functional and health status were similar. The analysis of 16 subgroups did not identify any with either clearly improved functional status or improved survival.
                In this HMO, comprehensive geriatric assessment by a consultation team, with limited follow-up, did not improve the health or survival of hospitalized patients selected on the basis of screening criteria. Some studies have shown improved outcomes with helicopter emergency medical services (HEMS) transport, while others have not. Safety concerns and cost have prompted reevaluation of the widespread use of HEMS.
                To determine whether the mode of transport of trauma patients affects mortality.
                Data for 56,744 injured adults aged ≥ 18 years transported to 62 U.S. trauma centers by helicopter or ground ambulance were obtained from the National Sample Program of the 2007 National Trauma Data Bank. In-hospital mortality was calculated for different demographic and injury severity groups. Adjusted odds ratios (AOR) were produced by utilizing a logistic regression model measuring the association of mortality and type of transport, controlling for age, gender, and injury severity (Injury Severity Score [ISS] and Revised Trauma Score [RTS]).
                The odds of death were 39% lower in those transported by HEMS compared with those transported by ground ambulance (AOR = 0.61, 95% confidence interval [CI] = 0.54-0.69). Among those aged ≥ 55 years, the odds of death were not significantly different (AOR = 0.92, 95% CI = 0.74-1.13). Among all transports, male patients had a higher odds of death (AOR = 1.23, 95% CI = 1.10-1.38) than female patients. The odds of death increased with each year of age (AOR = 1.040, 95% CI = 1.037-1.043) and each unit of ISS (AOR = 1.080, 95% CI = 1.075-1.084), and decreased with each unit of RTS (AOR = 0.46, 95% CI = 0.45-0.48).
                The use of HEMS for the transport of adult trauma patients was associated with reduced mortality for patients aged 18-54 years. In this study, HEMS did not improve mortality in adults aged ≥ 55 years. Identification of additional variables in the selection of those patients who will benefit from HEMS transport is expected to enhance this reduction in mortality. A prospective trial of 6% hetastarch (HES) v 5% plasma protein fraction (PPF) as the colloid component of intravenous (IV) fluid resuscitation was conducted in 32 patients with multisystem trauma and/or hemorrhagic shock. Patient age, mechanism and pattern of injury, and IV fluid requirements were similar in both groups. No intergroup differences were noted in indexes of hepatic, pulmonary, or renal function or in the incidence of infection. The frequency of other complications, including bleeding diatheses, and mortality were identical in the two groups. Although this investigation should be viewed as a pilot study, our results suggest that, compared with PPF, HES in large volumes is a safe, effective colloid solution in the resuscitation of patients with multisystem trauma and/or hemorrhagic shock. Further study of HES in a larger number of patients is warranted by these findings. The aim of this randomized controlled trial was to investigate the effect of a 4- to 6-week multimodal program of exercise, relaxation and psychoeducation on physical capacity, functional performance and quality of life (QOL) in allogeneic hematopoietic cell transplantation (allo-HSCT) adult recipients. In all, 42 patients were randomized to a supervised multimodal intervention or to a control group receiving usual care. The primary end point was on aerobic capacity measured in VO(2) max. Secondary end points were muscle strength, functional performance, physical activity level, QOL, fatigue, psychological well-being and clinical outcomes. The multimodal intervention had a significant effect on physical capacity: VO(2) max (P<0.0001) and muscle strength: chest press (P<0.0001), leg extension (P=0.0003), right elbow flexor (P=0.0009), right knee extensor (P<0.0001) and functional performance (stair test) (0.0008). Moreover, the intervention group showed significantly better results for the severity of diarrhea (P=0.014) and fewer days of total parenteral nutrition (P=0.019). Longitudinal changes in QOL, fatigue and psychological well-being favored the intervention group, but did not reach statistical significance. Assignment of a multimodal intervention during allo-HSCT did not cause untoward events, sustained aerobic capacity and muscle strength and reduced loss of functional performance during hospitalization. Trials assessing drug effectiveness for treatment of subarachnoid hemorrhage (SAH) often use mortality rates and Glasgow Outcome Scale scores as outcome measures. Neuropsychological and psychosocial measures might be more sensitive to outcomes, especially for patients of better-grade status.
                Eighteen of a total of 31 patients enrolled in the New Zealand arm of the Upjohn international, double-blind, therapeutic trial of tirilazad mesylate for women with SAH were assessed neuropsychologically and psychosocially 3 months after SAH. The 13 not assessed either had died or remained vegetative (9 patients), did not speak English (1 patient), or did not consent (3 patients). The drug code was broken after all assessments had been scored.
                Sixteen of the 31 patients had received the drug and 15 the vehicle. There were no differences between the two groups with respect to age, grades assessed at admission and 14 weeks after SAH, Glasgow Outcome Scale scores assessed at 3 months, or mortality rates. In the subgroup assessed neuropsychologically, nine patients were in each of the drug- and vehicle-treated groups. No differences were found with respect to grades, Glasgow Outcome Scale scores, or values for an index that measured cognitive impairment in all tests, but vehicle-treated patients were more impaired with respect to measures of concentration, sustained attention, and psychomotor speed (P < 0.02), as well as debilitating fatigue (P < 0.01).
                The finding that the patients in the drug-treated group exhibited fewer impairments typical of diffuse cortical damage could be viewed as being consistent with the hypothesis that tirilazad mesylate protects neurons. Given the small size of this study, these results require confirmation with larger patient groups. Future drug trials should consider including neuropsychological tests in assessments of outcomes after SAH. If this is too costly, questions regarding fatigue levels might prove worthwhile. To describe long-term quality of life, intensive care, and hospital mortality in patients with acute renal and respiratory failure treated with one of two methods of renal replacement therapy (RRT).
                Cross-sectional survey of long-term survivors from a prospective observational study of two methods of RRT.
                A combined surgical and medical intensive care unit in a university hospital.
                One hundred and twenty-six patients with acute renal and respiratory failure who required treatment with RRT and mechanical ventilation. Interventions. (1) RRT for acute renal failure was with either continuous hemodialysis with ultrafiltration using biocompatible membranes and prostacyclin and heparin anticoagulation (CHDF) or intermittent hemodialysis using cuprophane membranes and heparin anticoagulation (IHD); (2) Health-related quality of life in long-term survivors was assessed with the SF-36 (HRQL) questionnaire.
                (1) There was no difference in ICU mortality (73.5% [39/53] IHD vs. 71.8% [46/64] CHDF, P = NS) or hospital mortality (83% [44/53] IHD vs. 76.5% [49/64] CHDF, P = NS) between the two RRT treatment groups. By 1999, there were 16 surviving patients; (2) Twelve of these survivors completed SF-36 forms (10 CHDF vs. 2 IHD). The overall physical health summary score and scores for seven of the health domains were significantly reduced. The mental health summary score and the domain mental health score did not differ from the general population.
                (1) The method of RRT used in ICU patients with ARF had no influence on survival; (2) The long-term survivors of multi-organ failure have poor physical health. Between 1993 and 1996, a total of 452 patients were entered into a randomized trial evaluating eliprodil (a non-competitive NMDA receptor antagonist) in patients suffering from severe head injury. The primary efficacy analysis concerned the Glasgow Outcome Score (GOS), six months after randomization. This outcome was classified into three ordered categories: good recovery; moderate disability, and the worst category made up by combining severe disability, vegetative state and dead. A sample size calculation was performed prior to the commencement of the study, using a formula which depends on the anticipated proportions of patients in the three different outcome categories, the proportional odds assumption and on the relationship between outcome and prognostic factors such as Glasgow Coma Score at entry. Owing to uncertainty about the influence of prognostic factors, and about the proportion of patients in the three GOS categories, a blinded sample size review was planned. This review was performed on the basis of the first 93 patients to respond, and this led to an increase in the sample size from 400 to 450. In this paper the pre-trial simulations showing that the type I error rate would be influenced and the power would be preserved will be presented, and the implementation of the procedure will be described. Traumatic coagulopathy contributes to early death by exsanguination and late death in multiple organ failure. Recombinant Factor VIIa (rFVIIa, NovoSeven) is a procoagulant that might limit bleeding and improve trauma outcomes.
                We performed a phase 3 randomized clinical trial evaluating efficacy and safety of rFVIIa as an adjunct to direct hemostasis in major trauma. We studied 573 patients (481 blunt and 92 penetrating) who bled 4 to 8 red blood cell (RBC) units within 12 hours of injury and were still bleeding despite strict damage control resuscitation and operative management. Patients were assigned to rFVIIa (200 μg/kg initially; 100 μg/kg at 1 hour and 3 hours) or placebo. Intensive care unit management was standardized using evidence-based trauma "bundles" with formal oversight of compliance. Primary outcome was 30-day mortality. Predefined secondary outcomes included blood products used. Safety was assessed through 90 days. Study powering was based on prior randomized controlled trials and large trauma center databases.
                Enrollment was terminated at 573 of 1502 planned patients because of unexpected low mortality prompted by futility analysis (10.8% vs. 27.5% planned/predicted) and difficulties consenting and enrolling sicker patients. Mortality was 11.0% (rFVIIa) versus 10.7% (placebo) (p = 0.93, blunt) and 18.2% (rFVIIa) versus 13.2% (placebo) (p = 0.40, penetrating). Blunt trauma rFVIIa patients received (mean ± SD) 7.8 ± 10.6 RBC units and 19.0 ± 27.1 total allogeneic units through 48 hours, and placebo patients received 9.1 ± 11.3 RBC units (p = 0.04) and 23.5 ± 28.0 total allogeneic units (p = 0.04). Thrombotic adverse events were similar across study cohorts.
                rFVIIa reduced blood product use but did not affect mortality compared with placebo. Modern evidence-based trauma lowers mortality, paradoxically making outcomes studies increasingly difficult. Hypertonic solutions effectively improve hemodynamic parameters in patients admitted to the emergency room. However, no significant differences in outcome were observed compared with standard isotonic treatment in most previously published studies. This study evaluates pretreatment prognostic factors that predict a beneficial effect of hypertonic solution in patients admitted to the emergency room with hemorrhagic hypovolemia in a prospective double-blind fashion. The patients (n = 212) were randomized upon admission to receive 250 mL intravenous (i.v.) bolus of hypertonic 7.5% NaCl + 6% dextran (HSD, n = 101), or isotonic 0.9% NaCl solutions (IS, n = 111) as the first treatment, followed by standard resuscitation. Pretreatment factors assessed were sex, age, cause of hypovolemia, revised trauma score (RTS), Glasgow index, and mean arterial pressure (MAP) on admission. Both groups were compared for survival at 24 h and 30 days postadmission. Infused volumes were registered. HSD administration significantly increased MAP and reduced i.v. crystalloid infusions to maintain hemodynamic parameters, compared with IS. There was no difference between groups in the number of blood transfusions administered. Overall complication rates in both groups were similar (24%). There was a significant difference (p < .03) in overall (30 days) survival rate between HSD (73%) and IS (64%) groups. The 24 h survival rate was significantly lower in IS (72%) compared with HSD (87%); p < .01. Multivariate analyses showed that RTS and MAP were identified as independent predictors for 24 h survival in the group that received HSD. When evaluated for overall survival rate, hypertonic infusion benefited significantly only patients with MAP < 70 mmHg (p < .01). Aprotinin has been used to decrease blood loss with complicated cardiac surgery but has not been investigated in extrapleural pneumonectomy, an operation that does not use cardiopulmonary bypass. In this prospective, randomized, placebo-controlled, double-blind trial, the authors investigated whether aprotinin decreased blood loss in patients who underwent this operation.
                After appropriate statistical design and institutional review board approval, eligible patients who were scheduled for extrapleural pneumonectomy were randomized to receive either aprotinin or placebo during the operation. Blood loss and survival data were obtained from electronic medical records and surgical databases.
                Of 20 patients who were enrolled, 16 patients met criteria for blood loss analysis. Four patients were excluded from the blood loss analysis: Three patients were inoperable because of tumor spread and underwent limited surgery, and 1 patient died intraoperatively because of acute, massive hemorrhage. The mean blood loss was 769 mL with aprotinin versus 1832 mL with placebo (P = .05; Wilcoxon test). All 20 patients were included in survival analyses. All 9 patients who received placebo died. In contrast, 7 of 11 patients who received aprotinin remained alive at the time of the current report. Kaplan-Meier survival curves differed significantly between the 2 groups (P = .0004). A Bayesian multivariate survival analysis of 18 patients who had complete data available on 8 prognostic variables indicated a posterior probability of .99 that aprotinin was beneficial.
                Aprotinin decreased blood loss. After accounting for covariate effects, there was a significant comparative benefit with aprotinin in postoperative survival. This finding was unexpected and could not be considered conclusive because of the small size of the current study. A confirmatory study may be warranted.
                (c) 2009 American Cancer Society. The results of a controlled trial to ascertain the usefulness of plasma infusion for the treatment of hemolytic-uremic syndrome (HUS) are reported. Criteria for admission were (1) observation within 8 days from first symptoms, (2) dialysis treatment required, and (3) no special treatments and no more than 25 ml blood/kg previously received. Children were subdivided according to age (less than or more than 3 years) and then randomly assigned to treatment with plasma or symptomatic therapy. Thirty-two children ranging in age from 4 months to 6 years entered this study; 17 received plasma (P+ group) and 15 only symptomatic therapy (P- group). The mean follow-up period was 16 months in both groups. Surgical renal biopsy was performed 29 to 49 days after onset in 11 P+ and 11 P- children, and 33 histologic findings were semiquantitatively evaluated. No death occurred in either group. No differences were found in blood pressure, proteinuria, or hematuria at the end of the follow-up period; in no case were severe arteriolar lesions found. There were no significant differences for the scores of the individual histologic measurements; on electron microscopy, no vascular changes were observed in seven children of the P+ group, whereas in five of seven of the P- group, thickening of the lamina rara interna and arteriolar damage were present. The ability of plasma to stimulate prostacyclin (PGI2) production, measured as its stable derivative 6-keto-PGF1 alpha, was within the normal range for all patients. In our patients with predominant glomerular involvement who were treated in a very early phase of HUS, infusions of plasma did not significantly influence the short- and medium-term clinical outcome and were not effective in severe HUS when given later in the course of the disease. A longer follow-up is needed to ascertain whether the presence of endothelial damage, demonstrated by electron microscopy in children who were not given plasma, is of clinical relevance. Both for hemicraniectomy and for hypothermia, several reports describe a beneficial effect in patients with malignant supratentorial cerebral ischemia. We compared the safety and the clinical outcome in patients with a malignant supratentorial infarction who were treated with hemicraniectomy alone (HA) or received a combination therapy with hemicraniectomy and hypothermia of 35 degrees C (HH), respectively.
                In a prospective and randomized study, 25 consecutive patients were treated after an ischemic infarction of more than two thirds of one hemisphere by HA (n=13 patients) or the HH combination therapy (n=12 patients). Safety parameters were compared between both treatment groups, the clinical outcome was assessed during treatment and after 6 months.
                Age, cranial CT or MRI findings, initial National institutes of Health Stroke Scale Score (NIHSSS) and level of consciousness were not significantly different between both groups. Hemicraniectomy was performed within 15+/- 6 h after the ischemic event. Hypothermia was induced immediately after surgery. Overall mortality was 12% (2/13 vs. 1/12 in the two groups), but none of these 3 patients died due to treatment-related complications. There were no severe side effects of hypothermia. Duration of need for intensive care or for mechanical ventilation and infectious status did not differ significantly between both groups, but the need for catecholamine application was increased in the HH group. The clinical outcome showed a tendency for a better outcome in the HH compared with the HA group with respect to status after 6 months, as assessed by the NIHSSS (10+/-1 vs. 11+/-3, p<0.08).
                The present study suggests that a combined therapy of mild hypothermia and hemicraniectomy in malignant brain infarction does not imply additional risks by side effects and improves functional outcome as compared with hemicraniectomy alone.
                Copyright (c) 2006 S. Karger AG, Basel. This report analyzes the effect of air versus ground interhospital transport on survival following multisystem injury. There were 136 air-transported patients versus 194 ground-transported patients. The groups were similar in trauma scores, ages, mechanism of injury, and organ systems injured. There was a statistically significant survival advantage for air-transported patients with trauma scores between 10 and 5 (82.8% survival vs. 53.5%, p = less than 0.001). The time interval between accident and admission to the authors' institution was similar for both groups. Important therapeutic interventions contributing to better survival by the air-transported group included higher incidences of endotracheal intubation (50% vs. 25%), blood transfusions (32% vs. 10%), larger volumes of electrolyte fluid (3.3 L per patient vs. 2.1 L per patient) as well as the use of MAST trousers (60.3% vs. 34.9%). Transport charges for both ground and air services were similar. However, helicopter charges met only 15% of the operational budget of the aeromedical service. The remainder of the costs were generated from hospital patient revenues. Overall, total hospital charges were similar for both groups and were influenced by the variability of length of stay, particularly for orthopedic patients. Stereotactic evacuation of hematoma has been reported to reduce the incidence of mortality and to improve functional outcome in patients with spontaneous putaminal hemorrhage. Stereotactic evacuation of hematoma has not been widely accepted as a standard therapy, however, because its effect on functional outcome has been regarded as marginal and there have been no randomized trials with sufficient statistical power to quantify the benefits of this procedure. The authors reassessed the value of stereotactic evacuation of hematoma by analyzing its impact on activities of living during the chronic period following spontaneous putaminal hemorrhage in a randomized study.
                Four hundred ninety patients were entered into the study. The severity of their hemorrhages was graded neurologically on admission (neurological grades: 1, eyes are open; 2, eyes are closed but open to weak stimuli; 3, eyes are closed but open to strong stimuli; 4, eyes do not open but extremities move to stimuli; and 5, eyes do not open and extremities do not move to stimuli). Patients with Grade 2 and those with Grade 3 were randomized into two groups with different treatment protocols (Group I, stereotactic evacuation of the hematoma; and Group II, conservative treatment). Patients assigned neurological Grade 4 or 5 were excluded from the study because a large-scale retrospective study in Japan revealed that surgical treatment in patients assigned to these neurological grades does not improve functional outcome. Among the 490 patients, 242 were randomized strictly. This patient population comprised 148 men and 94 women ranging in age from 38 to 80 years (mean 60.5 years). Compared with Group II, Group I treatment resulted in a lower mortality rate and better recovery to functional independence in patients with neurological Grade 3. In patients with Grade 2, Group I treatment contributed to a better recovery of functional outcome and a lower mortality rate, but the difference was not significant. Multivariate analysis confirmed that stereotactic evacuation of the hematoma was contributory to a better recovery in functional outcome.
                Stereotactic evacuation of hematoma is clearly of value in selected patients with spontaneous putuminal hemorrhage, whose eyes are closed but will open in response to strong stimuli (neurological Grade 3) on admission. ABSTRACT: INTRODUCTION: Inadequate initial treatment and delayed hemodynamic stabilization (HDS) may be associated with increased risk of death in severe sepsis patients. METHODS: In order to compare the hemodynamic efficacy and safety of 6% HES 130/0.4 and NaCl 0.9% for HDS in patients with severe sepsis, we designed a prospective, multicenter, active-controlled, double-blind, randomized study in intensive care units. RESULTS: 174 out of 196 patients reached HDS (88 and 86 patients for HES and NaCl, respectively). Significantly less HES was used to reach HDS vs. NaCl (1,379 ±886 ml in the HES group and 1,709 ±1,164 ml in the NaCl group (mean difference = -331± 1,033, 95% CI -640 to -21, P = 0.0185). Time to reach HDS was 11.8 10.1 hours vs. 14.3 ±11.1 hours for HES and NaCl, respectively. Total quantity of study drug infused over four consecutive days, ICU and hospital LOS, and area under the curve of SOFA score were comparable. Acute renal failure occurred in 24 (24.5%) and 19 (20%) patients for HES and NaCl, respectively (P = 0.454). There was no difference between AKIN and RIFLE criteria among groups and no difference in mortality, coagulation, or pruritus up to 90 days after treatment initiation. CONCLUSION: Significantly less volume was required to achieve HDS for HES vs. NaCl in the initial phase of fluid resuscitation in severe sepsis patients without any difference for adverse events in both groups. CLINICALTRIALS.GOV: NCT00464204. 1) To compare the outcomes of adult trauma patients transported to a level I trauma center by helicopter vs. ground ambulance. 2) To determine whether using a unique "natural experiment" design to obtain the ground comparison group will reduce potential confounders.
                Outcomes in adult trauma patients transported to a tertiary care trauma center by air were compared with outcomes in a group of patients who were accepted by the online medical control physician for air transport, but whose air missions were aborted for aviation reasons (weather, maintenance, out on a mission); these patients were subsequently transported by ground ambulance instead. Outcomes were also analyzed for a third ground control group composed of all other adult trauma patients transported by ground during this time period. Data were collected by retrospective database review of trauma patients transferred between July 1, 1997, and June 30, 2003. Outcomes were measured by Trauma Injury Severity Score (TRISS) analysis. Z and W scores were calculated.
                Three hundred ninety-seven missions were flown by LifeFlight during the study period vs. 57 in the clinical accept-aviation abort ground transport group. The mean ages, gender distributions, mechanisms of injury, and Injury Severity Scores (ISSs) were similar in the two groups. Per 100 patients transported, 5.61 more lives were saved in the air group vs. the clinical accept-aviation abort ground transport group (Z = 3.37). As per TRISS analysis, this is relative to the expected mortality seen with a similar group in the Major Trauma Outcomes Study (MTOS). The Z score for the clinical accept-aviation abort ground transport group was 0.4. The 1,195 patients in the third all-other ground control group had a higher mean age, lower mean ISS, and worse outcomes according to TRISS analysis (W = -2.02).
                This unique natural experiment led to better matched air vs. ground cohorts for comparison. As per TRISS analysis, air transport of the adult major trauma patient is associated with significantly improved survival as compared with ground transport. The objective of this pilot controlled study was to evaluate the extracorporeal liver assist device (ELAD) in patients with acute liver failure who were judged to still have a significant chance of survival (approximately 50%) and in those who had already fulfilled criteria for transplantation. Twenty-four patients were divided into two groups, 17 with a potentially recoverable lesion (group I) and 7 listed for transplantation (group II), and then randomly allocated to ELAD haemoperfusion or control. The median period of ELAD haemoperfusion was 72 hours (range 3-168 h). Biocompatibility of the device was good, with no acceleration in platelet consumption, and haemodynamic stability was maintained. Two patients were withdrawn from the study because of worsening of preexisting disseminated intravascular coagulation in one case and a hypersensitivity reaction in the other. Deterioration with respect to encephalopathy grade was more frequent in the control patients, 7 of 12 (58%), than in the ELAD-treated patients, 3 of 12 (25%). In group I where survival for the ELAD cases was 7 of 9 (78%), there was a higher than expected survival in the controls, 6 of 8 (75%). For group II cases, survival was 1 of 3 (33%) for the ELAD-treated patients, and 1 of 4 (25%) for the controls. Both of the survivors underwent transplantation. Assessment of additive function for the device revealed an improvement in galactose elimination capacity after 6 hours of haemoperfusion. Based on the results of this pilot-controlled trial, better indices of prognosis will be required, in addition to those used to select for transplantation, if patients at an earlier stage of clinical deterioration are to be included in future studies. There are still several concerns about the extensive and prolonged use of hydroxyethylstarch solution (HES) in critically ill patients. The effects of volume replacement with HES over 5 days on hemodynamics, laboratory data, and organ function were compared with volume therapy using human albumin (HA).
                Prospective, randomized study.
                Clinical investigations on a surgical intensive care unit (ICU) of a university hospital.
                150 traumatized patients (injury severity score > 15) and 150 postoperative patients with sepsis were analyzed.
                Either 10% low-molecular weight HES (HES-trauma, n = 75; HES-sepsis, n = 75) or 20% HA (HA-trauma, n = 75; HA-sepsis, n = 75) was given for 5 days to maintain the pulmonary capillary wedge pressure (PCWP) between 12 and 15 torr. The entire management of therapy of the patients was performed by physicians who were not involved in the study and blinded to the infusion regimen.
                In addition to extensive cardiorespiratory monitoring, several routine laboratory parameters for assessing pulmonary, renal, hepatic, and coagulation function were analyzed from arterial blood samples on the day of admission to the ICU and on the day of sepsis diagnosis, respectively ("baseline" value) and daily over the following 5 days. Mortality during and after the study did not differ significantly between the infusion groups. There were also no differences between the incidence of pulmonary, renal, or hepatic failure in the two subgroups. Mean arterial pressure, heart rate, and PCWP were similar in both subgroups, whereas cardiac index, oxygen delivery index, oxygen consumption index, and the ratio between the partial pressure of oxygen in arterial blood and fractional inspired oxygen were higher in the HES- than in the HA-treated groups. Standard coagulation parameters did not differ, albumin concentration increased significantly in both HA groups, and lactate concentrations decreased only in the HES-sepsis patients (from 2.8 +/- 0.5 to 1.5 +/- 0.4 mg/dl). Volume replacement using albumin was significantly (p < 0.001) more costly than therapy with HES.
                Volume therapy with 10% HES for 5 days in the ICU patient showed no disadvantages compared with an infusion regimen using 20% albumin. Volume replacement using HES may even be associated with improved hemodynamics. HES appears to be a valuable and significantly cheaper alternative to albumin--even for prolonged volume therapy in the critically ill patient.
Due to the methodological weakness of the available literature, and the considerable heterogeneity of effects and study methodologies, an accurate composite estimate of the benefit of HEMS could not be determined. Although five of the nine multivariate regression studies indicated improved survival associated with HEMS, the remainder did not. All were subject to a low quality of evidence as assessed by the GRADE Working Group criteria due to their non-randomised design. Similarly, TRISS-based studies, which all demonstrated improved survival, cannot be considered strong evidence because of their methodology, which did not randomize the use of HEMS. The question of which elements of HEMS may be beneficial for patients has not been fully answered. The results from this review provide motivation for future work in this area. This includes an ongoing need for diligent reporting of research methods, which is imperative for transparency and to maximise the potential utility of results. Large, multicentre studies are warranted as these will help produce more robust estimates of treatment effects. Future work in this area should also examine the costs and safety of HEMS, since multiple contextual determinants must be considered when evaluating the effects of HEMS for adults with major trauma.