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Examining blood transfusion methods for children with severe bleeding

Massive Transfusion in Children: a Platform RCT of Whole Blood Compared to Component Therapy and Tranexamic Acid to Placebo in Life-threatening Traumatic Bleeding

Phase 3 Interventional University of Pittsburgh · NCT06070350

This study is testing whether using a specific type of blood and a medication can help children with severe bleeding from injuries survive better than standard treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1000 (estimated)
AgesN/A to 17 Years
SexAll
SponsorUniversity of Pittsburgh Academic / other
Locations23 sites (Tucson, Arizona and 22 other locations)
Trial IDNCT06070350 on ClinicalTrials.gov

What this trial studies

The MATIC-2 trial is a multicenter, phase III clinical trial focused on children under 18 years old who are experiencing hemorrhagic shock due to traumatic injuries. It aims to compare the effectiveness of Low Titer Group O Whole Blood (LTOWB) against component therapy (CT) and Tranexamic Acid (TXA) against a placebo in reducing 24-hour all-cause mortality. Participants will be randomized to receive either LTOWB or CT, and TXA or placebo, with the study also assessing safety outcomes related to these interventions. The trial employs a Bayesian adaptive design to enhance its efficiency and responsiveness.

Who should consider this trial

Good fit: Ideal candidates are children under 18 years old with confirmed or suspected active life-threatening traumatic bleeding.

Not a fit: Patients with devastating traumatic brain injuries not expected to survive or those who have not received blood products may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce mortality rates in children suffering from traumatic life-threatening hemorrhage.

How similar studies have performed: Other studies have shown promise in using whole blood for transfusions, but this specific approach is novel and untested in this pediatric population.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Tucson, Arizona and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hemorrhagic ShockTrauma InjuryChildrenPediatricsTransfusion
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.