The effect of the administration of recombinant activated factor VII (NovoSeven (R)) on perioperative blood loss in patients undergoing transabdominal retropubic prostatectomy: the PROSE study

Transabdominal retropubic prostatectomy is associated with significant peri operative blood loss, often requiring blood transfusion. However, the admin istration of allogeneic blood and blood products may induce serious immunol ogical or infectious complications. Several studies show that recombinant a ctivated factor VII (rFVIIa; NovoSeven(R), Novo Nordisk A/S, Bagsvaerd, Den mark) induces short-term local hemostasis. This ongoing study will evaluate the safety and efficacy of rFVIIa on blood loss in patients with normal co agulation undergoing retropubic prostatectomy. Thirty-six patients will be randomized to three different dose levels and receive either rFVIIa as a si ngle intravenous bolus dose or saline. Perioperative blood loss will be ass essed from blood-volume suction containers and drains. Blood sample analysi s, physical examination and electrocardiography will be performed postopera tively. Eighteen patients have enrolled in the study Blood loss was 630-445 5 ml (mean = 1698 ml), while the number of red cell. transfusions varied be tween 0 and 4 units (mean = 0.9 units). None of the patients developed veno us 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, defin ite conclusions must await study completion. Blood Coagul Fibrinolysis 11 ( suppl 1):S129-S132 (C) 2000 Lippincott Williams & Wilkins.