Efficacy of aprotinin in children undergoing craniofacial surgery

Object. This prospective, randomized, placebo-controlled, double-blind trial was undertaken to assess the efficacy of aprotinin in reducing the need for blood transfusions in 39 children undergoing reconstructive craniofacial surgery. Methods. Two demographically similar groups-a total of 39 patients with a mean age of 1.2 +/- 1.2 years-were studied. The efficacy of aprotinin (240 mg/m(2) administered intravenously over 20 minutes, followed by infusions of 56 mg/m(2)/hr) was compared with that of an equal infusion of 0.9% saline (placebo). Patients in the aprotinin group received less blood per kilogram of body weight than patients in the placebo group (32 +/- 25 ml/kg compared with 52 +/- 34 ml/kg, respectively; p = 0.04). Those patients in whom aprotinin was administered experienced less change in their hematocrit levels during surgery (aprotinin -33 +/- 13% compared with placebo -44 +/- 9%, p = 0.01). Each patient underwent a transfusion as per study protocol, and there was no significant change in hernatocrit levels from the beginning to the end of surgery. The surgical faculty judged blood loss in patients in the aprotinin group to be significantly less than usual (p = 0.03). The use of aprotinin was also associated with reduced blood transfusion requirements during the first 3 postoperative days (p = 0.03). There was no adverse event reported in either the aprotinin or placebo group. Conclusions. Aprotinin decreased blood transfusion requirements in pediatric patients undergoing cramofacial reconstruction, thereby reducing the risks associated with exposure to banked blood components.