Trauma & major bleeding

Early and Empirical High-Dose Cryoprecipitate for Hemorrhage After Traumatic Injury: The CRYOSTAT-2 Randomized Clinical Trial

JAMAPublished Randomised controlled trial

Primary result · All-cause mortalityResult — go to the resultOdds ratio 0.96 95% CI 0.75–1.23

Authors' 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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