Use of Recombinant Activated Factor VII (Novoseven) in Trauma and Surgery: Analysis of Outcomes Reported to an International Registry

Abstract

The objective was to evaluate the efficacy and safety of recombinant activated factor VII in patients with massive bleeding. Forty-five patients with severe massive hemorrhage requiring>or= 14 transfusion units of packed red blood cells received recombinant activated factor VII. Postdrug blood loss and transfusion requirements were assessed, and mortality was compared with predicted outcomes. Blood loss was markedly reduced in 40 of 43 (93.0%) patients, and transfusion requirements decreased after recombinant activated factor VII administration. Mortality rate in trauma patients who had massive hemorrhage was significantly reduced compared with predictions using scoring systems. This may be associated with the use of recombinant activated factor VII. This study failed to demonstrate an improvement in surgical patients. The absence of concurrent controls prevents definitive conclusions regarding actual safety or efficacy of recombinant activated factor VII.

Off-label Reports of New Biologics: Exciting New Therapy or Dubious Research? Examples From Recombinant Activated Factor VII

“…Moreover, after repeated off-label experience it is very common for academic physicians to analyze and publish their findings as "new clinical studies" in the form of anecdotal uncontrolled results, small case series, or clinical reviews. Numerous examples of this pattern of reporting are seen with rFVIIa (reviewed in reference 3) including the report in this issue of the Journal of Intensive Care Medicine [4]. Small case series seeking to demonstrate early promising effects may then be used as "evidence" for the legitimacy of repeated and continuing off-label use, even though the rate of adverse events from off-label rFVIIa use is noteworthy [5].…”

Recombinant activated factor VII (rFVIIa/NovoSeven®) in the management of severe postpartum haemorrhage: initial report of a multicentre case series in Japan

“…Early control of bleeding and correction of the complications are essential to achieve a better patient outcome. As a haemostatic agent, rFVIIa is widely used to manage massive haemorrhage in non-haemophiliac patients as an off-label use [16][17][18][19]. Since the action of rFVIIa is limited to the site of tissue injury and tissue factor exposure, administration of rFVIIa is considered to be particularly useful in an obstetric setting where there is often bleeding from a large raw area of exposed tissue [20].…”

7 Procoagulators

“…Transfusion requirements of RBC concentrates decreased significantly, and the frequency of massive transfusions as well as the rate of acute respiratory distress syndrome (ARDS) compared to placebo were significantly reduced. In open trials on the use of rFVIIa in case of massive bleeding [28,47,63] 71 trauma patients received mean rFVIIa doses of 90-140 µg/kg body weight per patient using an average of 1.6 bolus injections.…”