Early and Empirical High-Dose Cryoprecipitate for Hemorrhage After Traumatic Injury: The CRYOSTAT-2 Randomized Clinical Trial
Primary result · All-cause mortalityResult — go to the resultOdds ratio 0.96 95% CI 0.75–1.23Authors' conclusion
Among patients with trauma and bleeding who required activation of a major hemorrhage protocol, the addition of early and empirical high-dose cryoprecipitate to standard care did not improve all cause 28-day mortality.
Study context
- Population
- Injured adults requiring activation of a major hemorrhage protocol with active hemorrhage, SBP <90 mm Hg at any time and ≥1 U blood component transfusion; 26 UK and US major trauma centres, 2017–20211,531 (95%) analysed
- Participants
- 1,604 adults
- Comparison
- Cryoprecipitate vs Standard care
- Cryoprecipitaten = 799
- Standard caren = 805reference
- Primary endpoint
- All-cause mortality (ITT population)
- Follow-up
- 28 days
Methodological detailsopen-label, parallel-group, international, multicentre
- Open-label
- Parallel-group
- International
- Multicentre
Primary result
All-cause mortality
Odds ratio
0.96
95% CI 0.75–1.23
P = 0.74
By group
Cryoprecipitate vs Standard care
OR 0.96 (95% CI 0.75–1.23); P = 0.74
As reported in the abstract
Safety
Thrombotic events
Thrombotic events
- No difference in safety outcomes or incidence of thrombotic events
Original publication
Early and Empirical High-Dose Cryoprecipitate for Hemorrhage After Traumatic Injury: The CRYOSTAT-2 Randomized Clinical Trial. JAMA. Published 21 November 2023. doi:10. 1001/ jama. 2023. 21019
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