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Could whole blood in the ambulance save more trauma patients?

NCT ID NCT04684719

Disease control Sponsor: Jason Sperry Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving low-titer type O whole blood to injured patients at risk of severe bleeding, before they reach the hospital, works better than standard care (fluids or blood components). Over 1,000 patients from 10 trauma centers took part. The main goal was to see if whole blood reduces deaths within 30 days, and researchers also looked at how the age of the blood affects outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
low-titer group O whole blood
What this could lead to
If it works, this could show that giving whole blood early in the field saves more lives than standard fluids or blood components for trauma patients with severe bleeding.
What could go wrong
The trial is complete, but results may not apply to all trauma settings. Whole blood has limited supply and storage age could affect its effectiveness. There are also risks like transfusion reactions or infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,020 people

The number who actually took part.

Started

Apr 2022

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 89 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1.) Injured patients at risk of hemorrhagic shock being transported from scene or referral hospital to a participating TOWAR trial site that meet requirements for initiation of blood or blood component transfusion AND 2A.) Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital or during transport OR 2B.) Systolic blood pressure ≤ 70mmHg at scene, at outside hospital or during transport Exclusion Criteria: 1. Wearing NO TOWAR opt-out bracelet 2. Age \> 90 or \< 18 years of age 3. Isolated fall from standing injury mechanism 4. Known prisoner or known pregnancy 5. Traumatic arrest with \> 5 minutes of CPR without return of vital signs 6. Brain matter exposed or penetrating brain injury (GSW) 7. Isolated drowning or hanging victims 8. Objection to study voiced by subject or family member at the scene 9. Inability to obtain IV or intraosseous access 10. Isolated burns without evidence of traumatic injury

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Conditions

The condition(s) this trial relates to.

Hemorrhage injury Shock, Hemorrhagic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemorrhagic shock Traumatic injury

Contacts and locations

Locations

  • Metrohealth Systems

    Cleveland, Ohio, 44109, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Cincinatti

    Cincinnati, Ohio, 45267, United States

  • University of Louisville

    Louisville, Kentucky, 40292, United States

  • University of Mississippi Medical Center (UMMC)

    Jackson, Mississippi, 39216, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • University of Washington

    Seattle, Washington, 98104, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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