CRYOSTAT-2
Trial question
What is the role of early empirical high-dose cryoprecipitate in patients with traumatic hemorrhage requiring activation of a major hemorrhage protocol?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
21.0% female
79.0% male
N = 1581
1581 patients (330 female, 1251 male).
Inclusion criteria: adult patients with active traumatic hemorrhage, an SBP < 90 mmHg, requiring activation of a major hemorrhage protocol, and receiving at least 1 U of a blood component transfusion.
Key exclusion criteria: transfer of a patient from another hospital; injuries compatible with life as assessed by trauma team leader; > 3 hours elapsed from the time of injury.
Interventions
N=785 cryoprecipitate (standard treatment with an additional 3 pools of 6-g fibrinogen as early as possible).
N=796 standard care (treatment according to the local medical professional with a balanced ratio of RBCs and FFP).
Primary outcome
All-cause mortality at day 28
25.3%
26.1%
26.1 %
19.6 %
13.1 %
6.5 %
0.0 %
Cryoprecipitate
Standard
care
No significant
difference ↔
No significant difference in all-cause mortality at day 28 (25.3% vs. 26.1%; OR 0.96, 96% CI 0.75 to 1.23).
Secondary outcomes
No significant difference in death at 6 hours from admission (7.1% vs. 8.6%; OR 0.82, 95% CI 0.58 to 1.17).
No significant difference in death at 24 hours from admission (11.2% vs. 12.2%; OR 0.91, 95% CI 0.63 to 1.31).
No significant difference in estimated death at 6 months from admission (26.1% vs. 27.7%; HR 0.96, 96% CI 0.79 to 1.17).
Safety outcomes
No significant difference in all thrombotic events at day 28.
Conclusion
In adult patients with active traumatic hemorrhage, an SBP < 90 mmHg, requiring activation of a major hemorrhage protocol, and receiving at least 1 U of a blood component transfusion, cryoprecipitate was not superior to standard care with respect to all-cause mortality at day 28.
Reference
Ross Davenport, Nicola Curry, Erin E Fox et al. Early and Empirical High-Dose Cryoprecipitate for Hemorrhage After Traumatic Injury: The CRYOSTAT-2 Randomized Clinical Trial. JAMA. 2023 Nov 21;330(19):1882-1891.
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