title: Safety and efficacy of a single bolus administration of recombinant factor VIIa in liver transplantation due to chronic liver disease.
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 microg/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.
authors: University of Pittsburgh Medical Center, Department of Anesthesiology, Pittsburgh, PA, USA.
authors: Raymond M
authors: RM
authors: Planinsic
authors: Jan
authors: J
authors: van der Meer
authors: Giuliano
authors: G
authors: Testa
authors: Luis
authors: L
authors: Grande
authors: Angel
authors: A
authors: Candela
authors: Robert J
authors: RJ
authors: Porte
authors: R Mark
authors: RM
authors: Ghobrial
authors: Helena
authors: H
authors: Isoniemi
authors: Peter Billeskov
authors: PB
authors: Schelde
authors: Elisabeth
authors: E
authors: Erhardtsen
authors: Goran
authors: G
authors: Klintmalm
authors: Sukru
authors: S
authors: Emre
mesh_terms: D000328:Adult; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D017707:Erythrocyte Transfusion / Q000706:statistics & numerical data; D005167:Factor VII / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D015942:Factor VIIa; D005260:Female; D006470:Hemorrhage / Q000517:prevention & control*; D006801:Humans; D017093:Liver Failure / Q000601:surgery*; D016031:Liver Transplantation / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D011300:Preoperative Care; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa