NCT04704869

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

A Multi-center, Randomized, Controlled Trial Evaluating the Effects of Early High-Dose Cryoprecipitate in Adult Patients With Major Trauma Hemorrhage Requiring Major Hemorrhage Protocol (MHP) Activation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,604 (actual)
• Sponsor: Bryan Cotton · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Trauma Injury

Interventions

Type	Name	Description
BIOLOGICAL	Cryoprecipitate	Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
BIOLOGICAL	Red Blood Cells	RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
BIOLOGICAL	Plasma	Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
BIOLOGICAL	Platelets	Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
BIOLOGICAL	Whole Blood	Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.

Timeline

• Start date: 2017-01-01
• Primary completion: 2021-12-01
• Completion: 2022-11-01
• First posted: 2021-01-12
• Last updated: 2025-01-14
• Results posted: 2023-02-21

Locations

25 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study