Safety and Hemostatic Effect of Recombinant Activated Factor Vii in Cirrhotic Patients Undergoing Partial Hepatectomy: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
Resource
AMERICAN JOURNAL OF SURGERY v.191 n.2 pp.245-249
Journal
AMERICAN JOURNAL OF SURGERY
Journal Volume
v.191
Journal Issue
n.2
Pages
245-249
Date Issued
2006
Date
2006
Author(s)
SHAO, YONG-FU
YANG, JIA-MEI
CHAU, GAY-YANG
LEE, PO-HUANG
Abstract
Background: Coagulopathy caused by cirrhosis may contribute to excessive bleeding during hepatectomy. We evaluated the hemostatic effect and safety of recombinant factor VIIa ( rFVlla) in cirrhotic patients undergoing partial hepatectomy . Methods: Patients were randomized to rFVIIa 50 or 100 mu g /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 cc 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. (c) 2006 Excerpta Medica Inc. All rights reserved.
Subjects
rFVIIa
cirrhosis
hepatectomy
hemostasis
Type
journal article