[Recombinant factor VIIa for the treatment of exsanguinating trauma patients: a matched-pair analysis from the Trauma Registry of the German Society for Trauma Surgery]. / Rekombinanter Faktor VIIa in der Hämorrhagiebehandlung des Schwerstverletzten: Eine Matched-pair-Analyse anhand des TraumaRegisters der Deutschen Gesellschaft für Unfallchirurgie.

ABSTRACT

BACKGROUND: The aim of the study was to assess whether the use of recombinant factor VIIa (rFVIIa) in trauma patients was associated with improved outcome. PATIENTS AND METHODS: Patients documented in the TraumaRegistry of the German Society for Trauma Surgery (primary admissions; Injury Severity Score, ISS ≥ 9) who received rFVIIa in the first 6 hours upon admission (rFVIIa +) were matched with patients that had not received rFVIIa (rFVIIa-). RESULTS: The matching comparison yielded two identical groups with 100 patients each (rFVIIa+ average age 40.6 ± 18.5 years, ISS 47.1 ± 16.7 versus rFVIIa- 40.1 ± 19.1 years, ISS 45.1 ± 15.6). Patients were administered an average of 18.3 ± 13.1 (rFVIIa+) versus 19.5 ± 14.0 (rFVIIa-) red blood cell units (p = 0.55) and 15.2 ± 13.7 (rFVIIa+) versus 15.0 ± 13.1 (rFVIIa-) units of fresh frozen plasma (p = 0.92). Thromboembolisms occurred in 5% (rFVIIa+) versus 2% (rFVIIa-) (p = 0.44), multiple organ failure (MOF) in 82% versus 62% (p = 0.003) and hospital mortality was 48% versus 43% (p = 0.57), respectively. CONCLUSION: The early use of rFVIIa in severely injured patients was not associated with either lower transfusion requirements or with mortality reduction but with increased MOF.