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Early Whole Blood in Patients Requiring Transfusion After Major Trauma

NCT01227005 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2018-06-04

Study results available
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Summary

The proposal will assess if patients who require massive transfusion can be accurately predicted early after emergency department arrival and assess if the use of stored whole blood during initial resuscitation will reduce transfusion needs compared to transfusion with component therapy and thus improve outcome.

Conditions

  • Trauma/Injury Problem

Interventions

BIOLOGICAL

Transfusion of blood products

The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).

Sponsors & Collaborators

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-08-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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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 NCT01227005 on ClinicalTrials.gov