APROTININ REDUCES BLOOD LOSS AND TRANSFUSION REQUIREMENTS IN ORTHOTOPIC LIVER TRANSPLANTATION: A PLACEBO-CONTROLLED MULTICENTER STUDY.

Abstract

1015 Intraoperative activation of the fibrinolytic system has been shown to contribute to the bleeding tendency during orthotopic liver transplantation (OLT). Aprotinin is a serine anti-protease and a potent inhibitor of fibrinolysis. Although small, retrospective studies have suggested that aprotinin may reduce blood loss in OLT, its indication remains controversial. We initiated a prospective, double-blind, placebo-controlled multicenter study (EMSALT) to test the hypothesis that aprotinin reduces blood loss in OLT. Six European liver transplant centers (Leiden, Rotterdam, Bologna, Huddinge, Brussels, Helsinki) participated in this study. Perioperative patient management, including blood transfusion were standardized according to the study protocol. Patients were randomized to either high dose aprotinin (2×106 KIU loading dose, followed by 1×106 KIU/hr and an additional bolus of 1×106 KIU 20 min before reperfusion), regular dose (2×106 KIU loading dose, followed by 0.5×106 KIU/hr), or placebo. Randomization was performed per center. After obtaining informed consent, 137 adult patients, who underwent their first OLT and met the inclusion criteria, were randomized. There were no significant differences in demographic data or severity of disease between the three groups. Primary end-points are presented in the tableTableThrombo-embolic events were seen in 1 patient in the high dose group, none of the patients in the regular dose group, and in 3 patients in the placebo group (p=0.41). Mortality (30 days) was not different between the three groups (6.5%, 4.7% and 8.3%; p=0.79). Conclusions: This prospective study shows that aprotinin is an effective and safe drug to help reduce blood loss and transfusion requirements in patients undergoing OLT.