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Can whole blood save more kids? major trial launches

NCT ID NCT06070350

Disease control Sponsor: Philip Spinella 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 7 times

Summary

This study tests two approaches for children under 18 with life-threatening bleeding from trauma. One compares whole blood to standard blood components; the other tests tranexamic acid against placebo. The goal is to see which reduces death within 24 hours. Up to 1,000 children will take part across multiple hospitals.

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) and Tranexamic Acid (TXA)
What this could lead to
If it works, this could establish better transfusion practices to save more children's lives after severe traumatic bleeding.
What could go wrong
This is a large Phase 3 trial, but results may not apply to all settings. Risks include transfusion reactions or unknown side effects of TXA in children.

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 1,000 people

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

Started

Nov 2024

Expected to finish

Oct 2028

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

Up to 17 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.

General Inclusion Criteria: 1. Children, defined as less than estimated18 years of age with traumatic injury 2. MTP activation for confirmed or suspected active life-threatening traumatic bleeding AND Confirmed or suspected active life-threatening traumatic bleeding with at least 2 of 3 of the following criteria: 1. Hypotension for age (\< 5% tile) 2. Tachycardia for age (\>95th % tile) 3. Traumatic injury with exam findings consistent with severe bleeding (e.g., penetrating injury, hemothorax, distended abdomen with bruising, amputation of limb). General Exclusion Criteria: 1. Patient with devastating traumatic brain injury not expected to survive due to magnitude of injury (example: Transhemispheric gunshot wound with signs of herniation, GCS score of 3 with fixed and dilated pupils) 2. MTP activated but no blood products given 3. Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products) 4. Patients who are known or suspected to be pregnant on clinical examination 5. Known prisoners as defined in protocol 6. Known ward of the state 7. Isolated hanging, drowning or burns 8. Previous enrollment in MATIC-2 9. Prior study opt-out with bracelet Exclusion Criteria for the TXA/Placebo Domain 1. Prehospital or pre-enrollment use of TXA 2. Greater than 3 hours since time of injury 3. History of seizure after the injury event 4. Known allergy or hypersensitivity reaction to TXA

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Conditions

The condition(s) this trial relates to.

Accidental Injuries injury Shock, Hemorrhagic

As listed by the trial registrant

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

Hemorrhagic shock Trauma injury

How to take part

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

  1. The places running it

    20 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

  • Arkansas Children's Hospital

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Children's Hospital of Pittsburgh of UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's Memorial Hermann Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Children's National Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Emory University-Arthur M. Blank Hospital

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Emory University-Scottish Rite Hospital

    TERMINATED

    Atlanta, Georgia, 30342, United States

  • LeBonheur Children's Hospital

    RECRUITING

    Memphis, Tennessee, 38103, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Primary Children's Hospital

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • The University of Texas Southwestern Medical Center

    TERMINATED

    Dallas, Texas, 75390, United States

  • Tulane School of Medicine

    WITHDRAWN

    New Orleans, Louisiana, 70118, United States

  • University of Arizona

    RECRUITING

    Tucson, Arizona, 84719, United States

  • University of California Davis

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • University of New Mexico

    RECRUITING

    Albuquerque, New Mexico, 87131, United States

  • University of Texas Health Science Center at San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Washington Harborview

    RECRUITING

    Seattle, Washington, 98195, United States

  • Vanderbilt University Medical Center

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37232, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Wake Forest, North Carolina, 27157, United States

  • Washington University of St. Louis

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.