rFVIIa is not recommended as a first line treatment for bleeding associated with trauma. It will be effective only when sources of major bleeding have been controlled. A recent multi centre randomised placebo controlled study demonstrated safety of rFVIIa in trauma patients with active bleeding1. It should be noted that recombinant factor VIIa is not licensed for the treatment of massive blood loss and its use is associated with a theoretical increased risk of thromboembolic complications. The decision to administer rFVIIa should be made by the duty consultant haematologist.

Indications for use of rFVIIa

• Patients with haemorrhage secondary to trauma who continue to bleed despite conventional management strategies and treatment with tranexamic acid and adequate blood product replacement according to the massive haemorrhage protocol should be considered for treatment with rFVIIa.
• Ideally platelets should be >50,000 x109/l and fibrinogen >1.5g/l prior to use.
• The decision to use rFVIIa should be made by two consultants (a consultant haematologist and the trauma consultant treating the patient).
• Treatment dose is 90μg/kg as a slow IV bolus over 2–5 minutes.
• A second dose of 90μg/kg may be given after 2 hours if required.
• Caution required if patient has a history of thromboembolic disease.
• For this off-license use, consent should be obtained from the patient if possible prior to use.