Prospective, Randomized, Double-Blind Study of High-Dose Aprotinin in Pediatric Cardiac Operations

Background. Perioperative aprotinin decreases postoperative blood loss in adults undergoing cardiac operations, but its role is less clear in children. Therefore, a trial of aprotinin in pediatric cardiac operations was conducted to study the efficacy of its use in children. Methods. Forty-two patients were randomly assigned to receive either high-dose aprotinin or placebo. Aprotinin efficacy was assessed using time from protamine administration to skin closure, postoperative blood loss and hemoglobin loss, and postoperative transfusion requirements. Measures of fibrinolysis (fibrin degradation product titers) and platelet preservation (β-thromboglobulin levels) were also assessed. Results. There were no statistically significant differ- ences between groups in any of the blood loss or transfusion parameters. Fibrin degradation product levels, measured 4 hours postoperatively, had increased significantly for control patients, but remained unchanged for the aprotinin group (p < 0.02). β-Thromboglobulin levels increased more rapidly during cardiopulmonary bypass in the control group (p = 0.03). Conclusions. Aprotinin appears to provide no clinical benefit in routine pediatric cardiac operations. A reduction in fibrinolysis, with perhaps an early preservation of platelet structure, is seen in the aprotinin group. (Ann Thorac Surg 1997;63:497–503)