Four-factor prothrombin complex concentrate (4F-PCC) is a lyophilized concentrate of coagulation factors that is commonly used for urgent reversal of warfarin and other vitamin K antagonists. 4F-PCC has been used to treat coagulopathy and bleeding in cardiac surgery patients. Recent observational studies suggest that 4F-PCC may also reduce blood product consumption for trauma patients. In order to test this hypothesis, researchers in France randomized 327 severe trauma patients (median age, 39 years; 73% men; median Injury Severity Score, 36) to receive either 4F-PCC (N=164) or a saline placebo (N=160) immediately after admission. In this multi-center, double-blinded superiority trial, no differences were found for blood product consumption (red blood cells, frosh frozen plasma, and platelets) during the first 24 hours after admission (12 units in the 4F-PCC arm compared to 11 units in the placebo arm, p=0.72). Furthermore, no differences were observed in 24-hour and 28-day mortality by treatment arm. However, patients in the 4F-PCC arm were more likely to have a thromboembolic event compared to those in the placebo arm (35% vs. 24%; relative risk, 1.48; 95% C.I., 1.04-2.10; p=0.03). Further research is needed to better understand trauma induced coagulopahty and the best treatments for these patients.
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