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

Methodology: 4/5
Usefulness: 3.5/5

Bouzat P, et al. JAMA. 2023 Mar 21:e234080. doi: 10.1001/jama.2023.4080. 

Question and Methods:  This double-blind, randomized, placebo-controlled superiority trial aimed to assess whether 4F-PCC decreases 24hr blood product consumption for trauma patients at risk of massive transfusion.  
Findings:  There was no statistically significant difference in median total 24hr blood product consumption (12 [5-19]U in 4F-PCC group vs. 11 [6-19]U in the placebo group) and more thromboembolic events in the 4F-PCC group (56 pts [35%] in 4F-PCC group vs. 37 patients [24%] in placebo group).  
Limitations:  Primary outcome was a surrogate endpoint rather than a patient-centered and a combination of 4F-PCC + TXA was used with TXA and 4F-PCC having a potential interactions causing increased VTE.  

Interpretation:  Given no benefit in reducing transfusion requirements and higher risks of VTE, 4F-PCC should not be used empirically in the resuscitation of trauma patients at risk for massive transfusion.  

Dr. Hailey Newton

JC Supervisor: Dr. Jeff Perry