Table 1

Randomised controlled trials investigating the use of rFVIIa in trauma

Author, YearPatient groupInterventionStudy typeOutcomesKey resultsComments
Boffard, 200517 143 blunt trauma patients requiring >6 units of bloodThree doses of intravenous rFVIIa or placebo, 200 μg/kg, 100 μg/kg, 100 μg/kg at time zero, 1 h and 3 hRandomised, blinded placebo-controlled trialNumber of units RBCs transfused over next 48 h. Also survival and adverse eventsNo difference in survival. Reduction in RBC transfusion in rFVIIa group (reduced by 2.6 units)
Boffard, 200517 134 penetrating trauma patients requiring >6 units of bloodThree doses of intravenous rFVIIa or placebo, 200 μg/kg, 100 μg/kg, 100 μg/kg at time zero, 1 h and 3 hRandomised, blinded placebo-controlled trial.Number of units RBCs transfused over next 48 h. Also survival and adverse eventsNo difference in survival or any other measured outcome
Hauser, 201018 573 trauma patients requiring between 4 and 8 units RBCs in the first 12 h following injuryThree doses of intravenous rFVIIa or placebo, 200 μg/kg, 100 μg/kg, 100 μg/kg at time zero, 1 h and 3 hRandomised, blinded placebo-controlled trial30-day mortalityNo difference in mortality between groups. No difference in adverse eventsTrial stopped due to lower mortality than predicted in trial study group