Futility Assessment of Recombinant Factor VII Activated for the Treatment of Hemorrhagic Shock Requiring Massive Transfusion

Abstract

Objective Recombinant human factor VII activated (rFVIIa) is an adjuvant therapy in patients receiving massive transfusion for hemorrhagic shock. We compared patient characteristics and outcomes to determine futility criteria for the administration of rFVIIa in patients receiving massive transfusion for hemorrhagic shock. Methods This was a retrospective cohort analysis of patients who received both massive transfusion and rFVIIa. Consecutive trauma patients were allocated to 1 of 2 cohorts: survivors and nonsurvivors. Results Seventy-two subjects comprised the study: 27 were survivors and 45 were nonsurvivors. A univariate analysis revealed that nonsurvivors were older and had a more profound coagulopathy as measured by prothrombin time. A stepwise logistic regression revealed an increased odds of death in those patients who were older (odds ratio [OR], 1.048; 95% CI, 1.008 −1.091), had a higher admission prothrombin time (OR, 1.561; 95% CI, 1.152-2.116), and received more fresh frozen plasma (OR, 1.098; 95% CI 1.023-1.179). In addition we saw a protective effect with increased platelet administration (OR, 0.645; 95% CI, 0.446-0.932). Conclusion The use of rFVIIa for massive transfusion in middle-aged patients with moderate coagulopathy experiencing hemorrhagic shock may be considered futile. However, if rFVIIa is to be used as part of a massive transfusion protocol, adequate administration of platelets should be ensured.