Effect of recombinant activated factor VII on perioperative blood loss in patients undergoing retropubic prostatectomy: a double-blind placebo-controlled randomised trial.
BACKGROUND
Recombinant activated factor VII (factor VIIa) has prohaemostatic effects in bleeding patients with coagulation abnormalities. We aimed to test the hypothesis that recombinant factor VIIa could reduce perioperative blood loss in patients with normal coagulation systems. Therefore, we assessed safety and efficacy of this drug in patients undergoing retropubic prostatectomy, which is often associated with major blood loss and need for transfusion.


METHODS
In a double-blind, randomised placebo-controlled trial, we recorded blood loss and transfusion requirements in 36 patients undergoing retropubic prostatectomy, who were randomised to receive an intravenous bolus of recombinant factor VIIa (20 microg/kg or 40 microg/kg) or placebo in the early operative phase.


RESULTS
Median perioperative blood loss was 1235 mL (IQR 1025-1407) and 1089 mL (928-1320) in groups given recombinant factor VIIa 20 microg/kg and 40 microg/kg, respectively, compared with 2688 mL (1707-3565) in the placebo group (p=0.001). Seven of twelve placebo-treated patients were transfused, whereas no patients who received 40 microg/kg recombinant factor VIIa needed transfusion. The odds ratio for receiving any blood product in patients treated with recombinant factor VIIa compared with control patients was 0 (95% CI 0.00-0.33) No adverse events arose.


CONCLUSIONS
An injection of recombinant factor VIIa can reduce perioperative blood loss and eliminate the need for transfusion in patients undergoing major surgery.
Friederich
Philip W
PW
Department of Vascular Medicine/Internal Medicine, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands.
Henny
Christiaan P
CP
Messelink
Embert J
EJ
Geerdink
Mark G
MG
Keller
Tymen
T
Kurth
Karl-Heinz
KH
Büller
Harry R
HR
Levi
Marcel
M
D000368:Aged; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D004311:Double-Blind Method; D005167:Factor VII / Q000627:therapeutic use*; D015942:Factor VIIa; D006801:Humans; D007431:Intraoperative Complications; D008297:Male; D008875:Middle Aged; D011468:Prostatectomy / Q000379:methods*; D011994:Recombinant Proteins / Q000627:therapeutic use*
D011994:Recombinant Proteins; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa