RCT | 4F-PCC fails to reduce blood product consumption and raises thromboembolic events in trauma patients

Summary: The PROCOAG Randomized Clinical Trial aimed to investigate the efficacy and safety of 4-factor prothrombin complex concentrate (4F-PCC) in trauma patients at risk of massive transfusion. Conducted in 12 French trauma centers, this double-blind, randomized, placebo-controlled superiority trial involved 324 patients. All patients were treated according to European traumatic hemorrhage guidelines and received early ratio-based transfusion (packed red blood cells:fresh frozen plasma ratio of 1:1 to 2:1). The primary outcome measured was 24-hour blood product consumption (efficacy), while arterial or venous thromboembolic events were assessed as a secondary outcome (safety).

The trial revealed no significant difference in 24-hour blood product consumption between the 4F-PCC and placebo groups, with median consumption of 12 units and 11 units, respectively. However, the study identified a statistically significant higher risk of thromboembolic events in the 4F-PCC group, with 35% of patients experiencing at least one event compared to 24% in the placebo group.

In conclusion, the study found no beneficial effect of incorporating 4F-PCC into a ratio-based transfusion strategy for patients with severe trauma at risk of massive transfusion. Furthermore, the higher rate of thromboembolic events in the 4F-PCC group indicated potential harm. The findings do not support the routine use of 4F-PCC in patients experiencing trauma who are at risk for extensive transfusion.

Article: 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 – JAMA (free for a limited period)

See also: Visual Abstract