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document
A prospective randomized trial of Duraflo II heparin-coated circuits in cardiac reoperations . BACKGROUND Heparin-coated circuits in cardiopulmonary bypass have been shown to decrease the systemic inflammatory responses associated with cardiopulmonary bypass . Previous clinical studies on low-risk patients who had coronary artery bypass grafting ( CABG ) and received full-dose systemic heparin did not have clearly improved clinical outcomes . We hypothesized that the beneficial effects of heparin-coated circuits might be seen in patients who had cardiac reoperations . METHODS Three hundred fifty patients who had reoperation with CABG only ( 58 % ) , or with valve operations ( 42 % ) were randomly assigned to receive either a heparin-coated ( Duraflo II ; study group ) or uncoated ( control group ) circuit . Clinical outcomes were compared and the variables were analyzed using the following three groups : entire populations of study group and control group , subgroup of patients who had CABG reoperation only , and a subgroup who had valve reoperation or combined valve and CABG reoperation . RESULTS Preoperative variables were the same in both groups . No difference in clinical outcomes could be demonstrated except that the percentage of patients with major bleeding episodes was significantly lower in the study group ( 1.2 % versus 5.4 % , p = 0.035 ) . In the subgroup analysis of patients who had valve reoperations , lower blood transfusion requirements in the intensive care unit ( p = 0.013 ) were found in the study group . When the subgroup of patients who had CABG reoperations was analyzed separately , there was a trend toward less reoperation for bleeding in the study group ( 0 % versus 4.0 % , p = 0.058 ) . CONCLUSIONS We conclude that the use of heparin-coated circuits was safe and imparted protection from reoperations for bleeding and major bleeding episodes . Material-independent blood activation ( eg , blood-air interface and cardiotomy suction ) blunted the total effect of the heparin-coated surface .
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Intervention_Pharmacological
Duraflo II heparin-coated circuits
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Intervention_Pharmacological
Heparin-coated circuits
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Intervention_Pharmacological
heparin
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Intervention_Pharmacological
heparin-coated circuits
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Intervention_Pharmacological
heparin-coated ( Duraflo II
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Intervention_Control
uncoated
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Outcome_Adverse-effects
percentage of patients with major bleeding episodes
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Outcome_Physical
valve reoperations
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Outcome_Physical
blood transfusion requirements
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Outcome_Physical
reoperation for bleeding
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Participant_Condition
cardiac reoperations .
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Participant_Condition
low-risk patients who had coronary artery bypass grafting ( CABG )
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Participant_Sample-size
Three hundred fifty
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Participant_Sample-size
subgroup
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Participant_Sample-size
study group