Examining blood transfusion methods for children with severe bleeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Arizona
  Tucson, Arizona, United States Recruiting
• Arkansas Children's Hospital
  Little Rock, Arkansas, United States Recruiting
• University of California Davis
  Sacramento, California, United States Recruiting
• Children's National Hospital
  Washington D.C., District of Columbia, United States Recruiting
• Emory University-Arthur M. Blank Hospital
  Atlanta, Georgia, United States Recruiting
• University of Mississippi Medical Center
  Jackson, Mississippi, United States Recruiting

Study contacts

• Principal investigator: Philip C Spinella, MD — Univesrity of Pittsburgh
• Study coordinator: Thomas Byers
• Email: tdb33@pitt.edu
• Phone: 412-383-2340

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.