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Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial

NCT04684719 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1020

Last updated 2026-02-12

No results posted yet for this study

Summary

Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma centers designed to determine the efficacy and safety of low titer whole blood resuscitation as compared to standard of care resuscitation in patients at risk of hemorrhagic shock and to appropriately characterize the hemostatic competency of whole blood relative to its age.

Conditions

  • Hemorrhagic Shock
  • Traumatic Injury

Interventions

BIOLOGICAL

low titer whole blood

low titer whole blood, group O kept to either 21 days or 35 days based upon which preservation process is employed at each respective participating site

BIOLOGICAL

Standard Care

crystalloid infusion or blood component transfusion resuscitation

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Jason Sperry

    lead OTHER

Principal Investigators

  • Jason L Sperry, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2025-07-28
Completion
2025-08-12
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 NCT04684719 on ClinicalTrials.gov