Efficacy and Safety of Early Administration of 4-Factor Prothrombin Complex Concentrate in Patients With Trauma at Risk of Massive Transfusion: The PROCOAG Randomized Clinical Trial
The study investigated the efficacy and safety of administering 4F-PCC in patients at risk of massive transfusion. The study was conducted in 12 designated trauma centers in France, involving consecutive patients with trauma at risk of massive transfusion. The study was a double-blind, randomized, placebo-controlled superiority trial. The primary outcome was 24-hour all blood product consumption, and arterial or venous thromboembolic events were a secondary outcome. The results showed that there was no significant reduction in 24-hour blood product consumption after administering 4F-PCC, and thromboembolic events were more common. The study concluded that the findings did not support systematic use of 4F-PCC in patients at risk of massive transfusion.