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Title: Safety and hemostatic effect of recombinant activated factor VII in cirrhotic patients undergoing partial hepatectomy: A multicenter, randomized, double-blind, placebo-controlled trial
Authors: Yong Fu Shao
Jia Mei Yang
Gar Yang Chau
Yongyut Sirivatanauksorn
Shou Xian Zhong
Elisabeth Erhardtsen
Supanit Nivatvongs
Po Huang Lee
Chinese Academy of Medical Sciences
Second Military Medical University
Veterans General Hospital-Taipei
Mahidol University
Peking Union Medical College
Novo Nordisk AS
Chulalongkorn University
National Taiwan University Hospital
Keywords: Medicine
Issue Date: 1-Feb-2006
Citation: American Journal of Surgery. Vol.191, No.2 (2006), 245-249
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 hepatectomy. Methods: Patients were randomized to rFVIIa 50 or 100 μg/kg or placebo, administered intravenously 10 minutes before surgery and every second hour during surgery. The primary efficacy end points were the proportion of patients receiving red blood cell (RBC) transfusions and the amount of RBCs transfused. The RBC transfusion trigger was blood loss of 500 mL. Safety end points included thromboembolic and adverse events. Results: No statistically significant effect of rFVIIa treatment on efficacy end points was observed. Serious and thromboembolic adverse events occurred at similar incidences in the study groups. Conclusions: Using blood loss as a transfusion trigger, the efficacy of rFVIIa in reducing the requirement for RBC transfusion was not established in this study. No safety concerns were identified. © 2006 Excerpta Medica Inc. All rights reserved.
ISSN: 00029610
Appears in Collections:Scopus 2006-2010

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