Aprotinin and transfusion requirements in orthotopic liver transplantation: a multicentre randomised double-blind study

Background Intraoperative hyperfibrinolysis contributes to bleeding during adult orthotopic liver transplantation. We aimed to find out whether aproti nin, a potent antifibrinolytic agent, reduces blood loss and transfusion re quirements. Methods We did a randomised, double-blind placebo-controlled trial in which six liver-transplant centres participated. Patients undergoing primary liv er transplantation were randomly assigned intraoperative high-dose aprotini n, regular-dose aprotinin, or placebo. Primary endpoints were intraoperativ e blood loss and transfusion requirements. Secondary endpoints were periope rative fluid requirements, postoperative blood transfusions, complications, and mortality. Findings 137 patients received high-dose aprotinin (n=46), regular-dose apr otinin (n=43), or placebo (n=48), Intraoperative blood loss was significant ly lower in the aprotinin-treated patients, with a reduction of 60% in the high-dose group and 44% in the regular-dose group, compared with the placeb o group (p=0.03). Total amount of red blood cell (homologous and autologous ) transfusion requirements was 37% lower in the high-dose group and 20% low er in the regular-dose group, than in the placebo group (p=0.02). Thromboem bolic events occurred in two patients in the high-dose group, none in the r egular-dose group, and in two patients in the placebo group (p=0.39). Morta lity at 30 days did not differ between the three groups (6.5%, 4.7%, and 8. 3%; p=0.79). Interpretation Intraoperative use of aprotinin in adult patients undergoing orthotopic liver transplantation significantly reduces blood-transfusion r equirements and should be routinely used in patients without contraindicati ons.