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

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