Factors in the Initial Resuscitation of Patients With Severe Trauma: The FiiRST-2 Randomized Clinical Trial
An erratum to this article was published (JAMA Netw Open, 1 Dec 2025 ↗)
Authors' conclusion
In this randomized clinical trial, clotting factor concentrates were not superior to FP for initial resuscitation of patients with trauma.
Study context
- Population
- Trauma patients aged ≥16 years with massive hemorrhage protocol (MHP) activation on admission, 6 level I trauma centres in Canada, April 2021–February 2023137 in primary analysis
- Participants
- 217 patients
- Comparison
- FC 4 g + PCC 2000 IU vs 4 FP units in MHP packs 1 and 2
- FC-PCCn = 107
- FPn = 110reference
- Primary endpoint
- Number of allogeneic blood product (red blood cell (RBC), FP, and platelet) units administered
- Follow-up
- 24 hours
Methodological detailsmulticentre, parallel-control, superiority, modified intention-to-treat, terminated after interim analysis, Trial terminated after interim analysis showed conditional power of less than 25%
- Multicentre
- Parallel-control
- Superiority
- Modified intention-to-treat
- Terminated after interim analysis
- Trial terminated after interim analysis showed conditional power of less than 25%
Primary result
As reported in the abstract
Allogeneic blood product units (RBC, FP, platelets) within 24 hours
Secondary outcomes
24-hour and 28-day mortality
- No significant differences
Safety
Thromboembolic complications
- No significant differences
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Factors in the Initial Resuscitation of Patients With Severe Trauma: The FiiRST-2 Randomized Clinical Trial. JAMA Netw Open. Published 2 September 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →