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Pragmatic Prehospital Group O Whole Blood Early Resuscitation Trial

NCT03477006 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2021-10-06

Study results available
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Summary

Despite advances in trauma resuscitation, a paucity of therapeutic interventions are available early enough to reduce the downstream morbidity and mortality attributable to hemorrhage, shock and coagulopathy. Due to the time sensitive nature of the treatment of hemorrhage, the ideal resuscitation intervention would entail use of a blood product containing all essential hemostatic components, closest to time of injury, where prevention or reversal of the devastating downstream consequences of shock and coagulopathy can occur. This proposal will characterized the efficacy of whole blood resuscitation initiated in the prehospital setting to patients in hemorrhagic shock which represents this ideal intervention post-injury. These results will have great potential to dramatically change the way trauma resuscitation occurs today.

Conditions

  • Hemorrhagic Shock

Interventions

BIOLOGICAL

Whole blood

Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Jason Sperry

    lead OTHER

Principal Investigators

  • Jason Sperry, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2020-10-30
Completion
2020-10-30
FDA Drug
Yes

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 NCT03477006 on ClinicalTrials.gov