MedTrace Logo

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

NCT04704869 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1604

Last updated 2025-01-14

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • Queen Mary University of London

    collaborator OTHER

  • NHS Blood and Transplant

    collaborator OTHER_GOV

  • Bryan Cotton

    lead OTHER

Principal Investigators

  • Bryan A Cotton, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2021-12-01
Completion
2022-11-01
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04704869 on ClinicalTrials.gov