A Double-Blind, Placebo-Controlled Trial of Epsilon-Aminocaproic Acid for Reducing Blood Loss in Coronary Artery Bypass Grafting Surgery

Background

Epsilon-aminocaproic acid is a plasmin inhibitor that potentially reduces perioperative bleeding when administered prophylactically to cardiac surgery patients. To evaluate the efficacy of ε-aminocaproic acid, a prospective placebo-controlled trial was conducted in patients undergoing primary coronary artery bypass grafting surgery.

Study design

One hundred patients were randomly assigned to receive either ε-aminocaproic acid (100 mg/kg before skin incision followed by 1 g/hour continuous infusion until chest closure, 10 g in cardiopulmonary bypass circuit) or placebo, and the efficacy of ε-aminocaproic acid was evaluated by the reduction in postoperative thoracic-drainage volume and in donor-blood transfusion up to postoperative day 12.

Results

Postoperative thoracic-drainage volume was significantly lower in the ε-aminocaproic acid group compared with the placebo group (ε-aminocaproic acid, 649 ± 261mL; versus placebo, 940 ± 626mL; p=0.003). There were no significant differences between the ε-aminocaproic acid and placebo groups in the percentage of patients requiring donor red blood cell transfusions (ε-aminocaproic acid, 24%; versus placebo, 18%; p=0.62) or in the number of units of donor red blood cells transfused (ε-aminocaproic acid, 2.2 ± 0.8 U; versus placebo, 1.9 ± 0.8 U; p=0.29). Epsilon-aminocaproic acid did not reduce the risk of donor red blood cell transfusions compared with placebo (odds ratio: 1.2, 95% confidence interval; 0.4 to 3.2, p=0.63).

Conclusions

Prophylactic administration of ε-aminocaproic acid reduces postoperative thoracic-drainage volume by 30%, but it may not be potent enough to reduce the requirement and the risk for donor blood transfusion in cardiac surgery patients. This information is useful for deciding on a therapy for hemostasis in cardiac surgery.