Safety and efficacy of a single bolus administration of recombinant factor VIIa in liver transplantation due to chronic liver disease.
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.
Planinsic
Raymond M
RM
University of Pittsburgh Medical Center, Department of Anesthesiology, Pittsburgh, PA, USA.
van der Meer
Jan
J
Testa
Giuliano
G
Grande
Luis
L
Candela
Angel
A
Porte
Robert J
RJ
Ghobrial
R Mark
RM
Isoniemi
Helena
H
Schelde
Peter Billeskov
PB
Erhardtsen
Elisabeth
E
Klintmalm
Goran
G
Emre
Sukru
S
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
D011994:Recombinant Proteins; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa