Patient Blood Management Guidelines: Module 1

Critical Bleeding Massive Transfusion

| Future directions |

5.1 Evidence gaps and areas of future research

5.1.6 Effect of recombinant activated factor VII on outcomes

Question 6 (interventional)

In patients with critical bleeding requiring massive transfusion, what is the effect of rFVIIa (prophylaxis or treatment) on morbidity, mortality and transfusion rate?

rFVIIa, recombinant activated factor VII

From the available Australian and New Zealand data, the median dose of rFVIIa used off license in critically bleeding patients is approximately 90μg/kg;94,96,97 however, lower doses (i.e. 45–60 μg/kg) have been used.

Further research is needed to determine, in patients with critical bleeding requiring massive transfusion, the efficacy, safety and dose of rFVIIa, through studies that:

  • clearly define the indication or trigger for the administration of the drug
  • include a placebo arm
  • take into account the indication for administration of component therapy, particularly platelets and cryoprecipitate (or fibrinogen concentrate), because the efficacy of rFVIIa depends on the availability of substrate fibrinogen and platelets.