Clinical experience with recombinant activated factor VII in a series of 45 trauma patients.

Aim: Haemorrhage control is a major priority in the care of trauma patients in military as in the civilian setting. About 50% of combat deaths are due to fatal bleeding. The aim of this analysis was to assess the efficacy and safety of recombinant activated factor VII (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsvaerd, Denmark) when used to treat trauma-related blood loss.

Patients And Methods: Forty-five patients aged 5-81 years (mean age 30.5 years) received rFVIIa (mean dose 73.6 microg/kg) for the management of trauma-related bleeding. Trauma was classified as blunt (n = 42) or penetrating (n = 3). The primary outcome measure was reduction of transfusion requirements; improvements in coagulation status post-rFVIIa were also noted.

Results: Haemostatic efficacy was achieved in 43/45 (95.6%) patients following rFVIIa administration, and transfusion requirements (defined as median units of packed red blood cells administered in the 24-hour period following rFVIIa administration) were reduced from 10 to 3 units (P < 0.001). Coagulation status also showed improvement (median values for activated partial thromboplastin time and prothrombin time decreased from 43 to 37 s [P < 0.001] and from 19 to 12 s [P = 0.026], respectively). No safety concerns were raised by the available data.

Conclusions: As this analysis has several limitations that are unavoidable when using global registries to collect and analyse data, our findings are not conclusive. However, these preliminary observations especially in those patients who underwent very early rFVIIa treatment offer further support for the use of rFVIIa in trauma.