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Pre-Hospital Use of Plasma for Traumatic Hemorrhage

NCT02303964 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2016-02-23

No results posted yet for this study

Summary

Type A Thawed Plasma (TP) will be compared in polytrauma patients who receive only Normal Saline (NS) (standard of care) before arrival at the hospital.

The purpose of this study is to determine if prehospital administration of thawed plasma can reduce mortality of patients who have lost a large amount of blood due to their injuries, compared to those receiving standard of care.

Conditions

  • Shock, Hemorrhagic

Interventions

BIOLOGICAL

Plasma

Type A thawed plasma (up to 2 units) will be administered to polytrauma subjects randomized to plasma arm of study

DRUG

Normal saline

Normal saline will be administered to polytrauma subjects randomized to normal saline arm of study

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Bruce D Spiess, MD, FAHA · VCU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-01-31
Completion
2016-01-31

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 NCT02303964 on ClinicalTrials.gov