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. FINDINGS 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. INTERPRETATION An injection of recombinant factor VIIa can reduce perioperative blood loss and eliminate the need for transfusion in patients undergoing major surgery.
The effect of the administration of recombinant activated factor VII (NovoSeven) on perioperative blood loss in patients undergoing transabdominal retropubic prostatectomy: the PROSE study
Blood Coagulation & Fibrinolysis. 2000;11((Suppl 1):):S129-32.
Transabdominal retropubic prostatectomy is associated with significant perioperative blood loss, often requiring blood transfusion. However, the administration of allogeneic blood and blood products may induce serious immunological or infectious complications. Several studies show that recombinant activated factor VII (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsvaerd, Denmark) induces short-term local hemostasis. This ongoing study will evaluate the safety and efficacy of rFVIIa on blood loss in patients with normal coagulation undergoing retropubic prostatectomy. Thirty-six patients will be randomized to three different dose levels and receive either rFVIIa as a single intravenous bolus dose or saline. Perioperative blood loss will be assessed from blood-volume suction containers and drains. Blood sample analysis, physical examination and electrocardiography will be performed postoperatively. Eighteen patients have enrolled in the study. Blood loss was 630-4455 ml (mean = 1698 ml), while the number of red cell transfusions varied between 0 and 4 units (mean = 0.9 units). None of the patients developed venous thromboembolism. An independent committee performed an interim analysis after patient 12 and identified a positive trend between treatment groups (not statistically significant). Although a single bolus injection of rFVIIa appears to decrease perioperative blood loss safely and effectively, definite conclusions must await study completion.