Background Management of trauma patients with severe bleeding has led to criteria before considering use of recombinant activated factor VII (rFVIIa), including haemoglobin >8 g dl−1, serum fibrinogen ≥1.0 g l−1, platelets >50,000 × 109l−1, arterial pH ≥ 7.20, and body temperature ≥34 °C. We hypothesized that meeting these criteria is associated with improved outcomes. Methods In this prospective cohort study of 26 French trauma centres, subjects were included if they received rFVIIa for persistent massive bleeding despite appropriate care after severe blunt and/or penetrating trauma. Results After surgery and/or embolization as haemostatic interventions, 112 subjects received a first dose of 103 μg kg−1rFVIIa (82-200) (median, 25th-75thpercentile) at 420 min (285-647) post-trauma. Of these, 71 (63%) “responders” were still alive at 24h post-trauma and had their transfusion requirements reduced by > 2 packed red blood cell units after rFVIIa treatment. Mortality was 54% on day 30 post-trauma. There were 21%, 44% and 35% subjects who fulfilled 0-1, 2-3 or 4-5, respectively, of the guidelines before receiving rFVIIa. Survival at day 30 was 13%, 49% and 64% and the proportion of responders was 39%, 64% and 82%, when subjects fulfilled 0-1, 2-3 or 4-5 conditions, respectively (both P Conclusions In actively bleeding trauma patients, meeting guideline criteria before considering rFVIIa was associated with lower mortality and a higher proportion of responders to the rFVIIa.
