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Can whole blood beat component transfusions in trauma?

NCT ID NCT05638581

Disease control Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial asks whether giving severely injured patients whole blood (Low-Titer Group O) is better than giving them separate blood components (red cells, plasma, platelets, and cryoprecipitate) during emergency transfusions. It enrolls about 1,100 adults with major traumatic bleeding who need large-volume transfusions. The main goal is to see if whole blood improves survival within the first 6 hours after transfusion begins.

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 (LTOWB) compared with standard blood components (red cells, plasma, platelets, cryoprecipitate)
What this could lead to
If whole blood proves better, it could become the standard emergency transfusion for trauma, potentially saving more lives in the critical first hours.
What could go wrong
The trial is large but results may not apply to all settings, and whole blood may not always be available or superior for every patient.

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

About 1,100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

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

15 years and older

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. Adult trauma patient (estimated age \> 15 or weight \> 50 kg, if age unknown) 2. Patient taken to trauma center directly from scene 3. Commencement of blood transfusion (PRBC, plasma or LTOWB), in pre-hospital or in-hospital setting 4. Activation of site-specific Massive Hemorrhage Protocol or Massive Transfusion Protocol 5. Traumatic injury with at least one of the following: 1. Confirmed or suspected acute major bleeding 2. Assessment of Blood Consumption (ABC) Score ≥2 Exclusion Criteria: 1. Patients who have received, prehospital or in-hospital more than two units of LTOWB; the equivalent in components (two units of packed red blood cells and two units of plasma); or a combination of the two (more than one unit of LTOWB, one unit of packed cells, and one unit of plasma). Most trauma centers hold two units of either packed red blood cells (with two units of plasma) or two units of LTOWB in the emergency department. This stock is used to initiate transfusion, while the massive hemorrhage protocol is activated from the blood bank. 2. Patients transferred from another hospital 3. Children \<15 years (in most communities, patients aged 15-18 years are treated at adult trauma centers, and patients in this age group frequently suffer life-threatening injuries, and will therefore be included) 4. Known prisoners, defined as individuals involuntarily confined or detained in a penal institution (including juvenile detention, involuntary psychiatric commitment, or court-ordered residential substance abuse treatment) 5. Moribund patients expected to die within 1 hour 6. Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products) 7. Patients with known "do not resuscitate" orders prior to randomization 8. Patients who refuse the administration of blood products 9. Individuals with a research "opt out" bracelet. 10. Greater than 20% total body surface area (TBSA) burns 11. Suspected inhalation injury victims 12. Patients who are obviously pregnant on clinical examination or known to be pregnant as provided by the subject or legally authorized representative

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Conditions

The condition(s) this trial relates to.

Hemorrhage injury Shock Shock, Hemorrhagic

As listed by the trial registrant

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

Shock, hemorrhagic Wounds and injuries

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atrium Health Wake Forest Baptist

    NOT_YET_RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Froedtert Hospital

    NOT_YET_RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Harborview Medical Center

    RECRUITING

    Seattle, Washington, 98104, United States

  • Los Angeles County + University of Southern California (LAC + USC) Medical Center

    NOT_YET_RECRUITING

    Los Angeles, California, 90033, United States

  • Oregon Health and Sciences University Hospital

    NOT_YET_RECRUITING

    Portland, Oregon, 97239, United States

  • Penn Presbyterian Medical Center

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University Medical Center New Orleans LCMC Health

    NOT_YET_RECRUITING

    New Orleans, Louisiana, 70112, United States

  • University of Alabama at Birmingham, UAB Hospital

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Maryland Medical Center

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Texas Health San Antonio and University Health System

    NOT_YET_RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Texas Health Science Center Houston

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Washington University School of Medicine

    NOT_YET_RECRUITING

    St Louis, Missouri, 63110, United States

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