CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,604 enrolled
Drug / intervention
Cryoprecipitate +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04704869
NCT04704869Phase 3Completed

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

Bryan Cotton·interventional·Posted Jan 12, 2021·Updated Jan 14, 2025

In Brief

A Phase 3 clinical trial evaluating Cryoprecipitate, Red Blood Cells, and 3 other interventions for Trauma Injury. Completed, enrolled 1,604 participants across 25 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTrauma Injury
CountriesUnited Kingdom, United States

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 12, 2021
Enrollment StartJan 1, 2017
Primary CompletionDec 1, 2021
Study CompletionNov 1, 2022
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 5.5 years ago

Interventions

Cryoprecipitatebiological

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).

Red Blood Cellsbiological

RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.

Plasmabiological

Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.

Plateletsbiological

Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.

Whole Bloodbiological

Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.