Hemorrhage, Transfusions and the Use of rFVIIa; The Use of rFVIIa following TBI

Lead Investigator: M. Margaret Knudson MD

Brief Summary of the Project: After obtaining a grant from the Western Trauma Foundation (obtained initially from the Novo Nordisk Pharmaceutical Company), members of the San Francisco Injury Center initiated a multi-center observational study aimed at collecting data on how the pro-coagulant recombinant factor VIIa was being utilized in trauma centers in the United States. We designed a secure website for data collection, analyzed the data, and presented the trauma/transfusion data at the annual meeting of the American Association for the Surgery of Trauma and it was subsequently published in the Journal of the American College of Surgeons in January 2011. The analysis of the use of rFVIIa in patients with TBI was presented in February at the annual meeting of the Pacific Coast Surgical Association and has been submitted to the Journal of Trauma for publication.

Results: Trauma, Transfusions and the Use of Recombinant Factor VIIa: A Multicenter Case Registry Report of 380 Patients from the Western Trauma Association: 380 injured patients who received rFVIIa as an adjunct for hemorrhage control were included in this analysis. The means time from admission to administration of rFVIia was 4.6 hours, with an average transfusion of 18 U blood before administration. Death from hemorrhage rate was 30%. Predictors of a poor response to rFVIIa were a pH < 7.2 (p<0.0001), a platelet count < 100,000 (P-0.046), and blood pressure <90 mmHg (p<0.0001) at the time of administration. Based on this case registry review, the precise role of rFVIIa in traumatic hemorrhage is unclear. Surgeons choosing to use this drug as an adjunctive measure to reverse coagulopathy are advised to first correct shock, acidosis, and thrombocytopenia.