Safety and efficacy of a single bolus administration of recombinant factor VIIa in liver transplantation due to chronic liver disease

Raymond M. Planinsic, Jan van der Meer, Giuliano Testa, Luis Grande, Angel Candela, Robert J. Porte, R. Mark Ghobrial, Helena Isoniemi, Peter Billeskov Schelde, Elisabeth Erhardtsen, Goran Klintmalm, Sukru Emre

Research output: Contribution to journalArticle

181 Scopus citations

Abstract

Orthotopic liver transplantation (OLT) can be associated with excessive blood loss. As a result, there may be increased risk of adverse outcomes. Activated recombinant factor VII (rFVIIa) has demonstrated the ability to improve hemostasis in a variety of disorders; however, there has been a limited amount of research into its use in OLT. The purpose of this dose-finding study was to examine the efficacy and safety of rFVIIa in the reduction of bleeding in patients undergoing OLT. In this double-blind trial, patients with end-stage liver disease scheduled for OLT were randomized to 1 of 4 parallel study groups. They received a single intravenous bolus of rFVIIa (20,40, or 80 μg/kg) or placebo prior to surgery. The primary assessment endpoint was the total number of red blood cell (RBC) units transfused perioperatively. Safety was evaluated by adverse events reported. Eighty-three comparable patients were randomized to receive study product, with 82 ultimately undergoing OLT. There were no significant differences in required RBC units between the placebo and rFVIIa study groups. The number of adverse events was comparable between study groups. In conclusion, rFVIIa has a good safety profile in patients undergoing OLT. However, the doses studied did not have any effect on the number of RBC transfusions required.

Original languageEnglish (US)
Pages (from-to)895-900
Number of pages6
JournalLiver Transplantation
Volume11
Issue number8
DOIs
StatePublished - Aug 1 2005

ASJC Scopus subject areas

  • Surgery
  • Hepatology
  • Transplantation

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