Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation

Phase 3 Completed 1604 enrolled Bryan Cotton NHS Blood and Transplant · collab Queen Mary University of London · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this trial is to compare standard of care (SOC) massive transfusion protocol to SOC massive transfusion protocol plus early use of cryoprecipitate (within 90 minutes of emergency department arrival).

Timeline

Start: 2017-01
Primary completion: 2021-12-01
Completion: 2022-11-01

Outcome

Missed primary endpoint

paper mortality in the intention-to-treat population was 26.1% in the standard care group vs 25.3% in the cryoprecipitate group (odds ratio, 0.96 [95% CI, 0.75-1.23]; P = .74). PMID 37824155 ↗

paper the addition of early and empirical high-dose cryoprecipitate to standard care did not improve all cause 28-day mortality. PMID 37824155 ↗

Publications

Results Davenport R, Curry N, Fox EE, Thomas H, Lucas J, Evans A, Shanmugaranjan S, Sharma R, Deary A, Edwards A, Green L, Wade CE, Benger JR, Cotton BA, Stanworth SJ, Brohi K; CRYOSTAT-2 Principal Investigators. 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. doi: 10.1001/jama.2023.21019.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cryoprecipitate	Protein / enzyme biologic	3 unknown	—
Background	BLOOD CELLS, RED	Unknown	—	—
Background	BLOOD, WHOLE	Other / unclassified	—	—
Background	Plasma	Other / unclassified	—	—
Background	Platelets	Other / unclassified	—	—

Indications

No indication recorded.