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document
A phase III , double-blind , placebo-controlled , multicenter study on the efficacy of recombinant human antithrombin in heparin-resistant patients scheduled to undergo cardiac surgery necessitating cardiopulmonary bypass . BACKGROUND The study evaluated the efficacy of recombinant human antithrombin ( rhAT ) for restoring heparin responsiveness in heparin resistant patients undergoing cardiac surgery . METHODS This was a multicenter , randomized , double-blind , placebo-controlled study in heparin-resistant patients undergoing cardiac surgery with cardiopulmonary bypass . Heparin resistance was diagnosed when the activated clotting time was less than 480 s after 400 U/kg heparin . Fifty-four heparin-resistant patients were randomized . One cohort received 75 U/kg rhAT , and the other received normal saline . If the activated clotting time remained less than 480 s , this was considered treatment failure , and 2 units fresh frozen plasma was transfused . Patients were monitored for adverse events . RESULTS Only 19 % of patients in the rhAT group received fresh frozen plasma , compared with 81 % of patients in the placebo group ( P < 0.001 ) . During their hospitalization , 48 % of patients in the rhAT group received fresh frozen plasma , compared with 85 % of patients in the placebo group ( P = 0.009 ) . Patients in the placebo group required higher heparin doses ( P < 0.005 ) for anticoagulation . There was no increase in serious adverse events associated with rhAT . There was increased blood loss 12 h postoperatively ( P = 0.05 ) with a trend toward increased 24-h bleeding in the rhAT group ( P = 0.06 ) . There was no difference between the groups in blood and platelet transfusions . CONCLUSION Treatment with 75 U/kg rhAT is effective in restoring heparin responsiveness and promoting therapeutic anticoagulation in the majority of heparin-resistant patients . Treating heparin-resistant patients with rhAT may decrease the requirement for heparin and fresh frozen plasma .
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
recombinant human antithrombin
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Intervention_Pharmacological
recombinant human antithrombin ( rhAT )
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Intervention_Pharmacological
Heparin
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Intervention_Pharmacological
heparin
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Intervention_Pharmacological
received 75 U/kg rhAT
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Intervention_Pharmacological
received normal saline
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Intervention_Pharmacological
rhAT
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Intervention_Control
placebo
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Intervention_Pharmacological
rhAT
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Intervention_Control
placebo
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Intervention_Pharmacological
heparin
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Intervention_Pharmacological
rhAT
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Intervention_Pharmacological
rhAT
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Intervention_Pharmacological
rhAT
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Intervention_Pharmacological
rhAT
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Outcome_Physical
heparin responsiveness
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Outcome_Adverse-effects
no increase in serious adverse events
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Outcome_Adverse-effects
increased blood loss
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Outcome_Adverse-effects
24-h bleeding
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Outcome_Physical
effective in restoring heparin responsiveness
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Outcome_Physical
therapeutic anticoagulation
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Outcome_Physical
decrease the requirement for heparin
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Participant_Condition
scheduled to undergo cardiac surgery necessitating cardiopulmonary bypass
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Participant_Condition
cardiac surgery
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Participant_Sample-size
Fifty-four