Reduced mortality by meeting guideline criteria before using recombinant activated factor VII in severe trauma patients with massive bleeding

Br J Anaesth. 2016 Oct;117(4):470-476. doi: 10.1093/bja/aew276.


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 x 109 l-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-1 rFVIIa (82-200) (median, 25th-75th percentile) 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 <0.01).

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.

Keywords: factor VIIa; haemorrhage; shock, traumatic.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Factor VIIa / adverse effects
  • Factor VIIa / therapeutic use*
  • Female
  • Guideline Adherence*
  • Hemorrhage / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Practice Guidelines as Topic
  • Prospective Studies
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / therapeutic use
  • Wounds and Injuries / mortality*


  • Recombinant Proteins
  • recombinant FVIIa
  • Factor VIIa