Safety and hemostatic effect of recombinant activated factor VII in cirrhotic patients undergoing partial hepatectomy: a multicenter, randomized, double-blind, placebo-controlled trial

摘要: Abstract Background Coagulopathy caused by cirrhosis may contribute to excessive bleeding during hepatectomy. We evaluated the hemostatic effect and safety of recombinant factor VIIa (rFVIIa) in cirrhotic patients undergoing partial Methods Patients were randomized rFVIIa 50 or 100 μg/kg placebo, administered intravenously 10 minutes before surgery every second hour surgery. The primary efficacy end points proportion receiving red blood cell (RBC) transfusions amount RBCs transfused. RBC transfusion trigger was loss 500 mL. Safety included thromboembolic adverse events. Results No statistically significant treatment on observed. Serious events occurred at similar incidences study groups. Conclusions Using as a trigger, reducing requirement for not established this study. concerns identified.