Early and Empirical High-Dose Cryoprecipitate for Hemorrhage After Traumatic Injury: The CRYOSTAT-2 Randomized Clinical Trial | Emergency Medicine | JAMA | JAMA Network

joi230124va_1697657864.73553.png

Title: Early and Empirical High-Dose Cryoprecipitate for Hemorrhage After Traumatic Injury
Objective: Assess if early and high-dose cryoprecipitate improves survival in trauma patients with bleeding.
Design & Setting: Phase 3, interventional randomized trial; 26 major trauma centers in UK and US, Aug 2017 - Nov 2021.
Participants: 1604 adult trauma patients with active hemorrhage, requiring major hemorrhage protocol (MHP) activation.
Intervention: Standard care vs. standard care plus early administration of 3 pools of cryoprecipitate (6-g fibrinogen equivalent) within 90 mins of randomization and 3 hours of injury.
Primary Outcome: All-cause mortality at 28 days.
Results:
- 25.3% mortality in cryoprecipitate group vs. 26.1% in standard care (OR 0.96; 95% CI 0.75-1.23; P = .74).
- No significant difference in safety outcomes or thrombotic events (12.7% vs. 12.9%).
- No observed differences in secondary outcomes like transfusion requirements, critical care, hospital stays, EQ-5D-5L score, or Glasgow Outcome Scale score.

Effectiveness of Cryoprecipitate: Early and high-dose cryoprecipitate did not significantly improve 28-day mortality in trauma patients requiring MHP activation.
Safety Profile: The safety profile (thrombotic events) was similar between the cryoprecipitate and standard care groups.
Implications for Practice: This study challenges the efficacy of early high-dose cryoprecipitate in trauma hemorrhage, indicating the need for further research to optimize bleeding management strategies in trauma care.