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.
JC Supervisor: Dr. Jeff Perry
Dr. Newton is an FRCPC Emergency Medicine resident at the University of Ottawa.
Dr. Rosenberg is an emergency physician at the Ottawa Hospital, associate professor at the University of Ottawa, and Director of the Digital Scholarship and Knowledge Dissemination Program.
Dr. Perry is an Emergency Physician and full Professor in the department of Epidemiology and Community Medicine. He has a special research interest in subarachnoid hemorrhage, TIA and stroke.