Status:
RECRUITING
Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children
Lead Sponsor:
Philip Spinella
Collaborating Sponsors:
Biomedical Advanced Research and Development Authority
Conditions:
Hemorrhagic Shock
Trauma Injury
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE3
Brief Summary
The MATIC-2 is a multicenter clinical trial enrolling children who are less than 18 years of age with hemorrhagic shock potentially needing significant blood transfusion. The primary objective of the...
Detailed Description
The MATIC-2 trial is a Bayesian, randomized, multicenter, adaptive platform phase III trial. The trial will include injured children with hemorrhagic shock anticipated to require massive blood transfu...
Eligibility Criteria
Inclusion
- General
- Children, defined as less than estimated18 years of age with traumatic injury
- 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:
- Hypotension for age (\< 5% tile)
- Tachycardia for age (\>95th % tile)
- Traumatic injury with exam findings consistent with severe bleeding (e.g., penetrating injury, hemothorax, distended abdomen with bruising, amputation of limb).
- General
Exclusion
- 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)
- MTP activated but no blood products given
- Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products)
- Patients who are known or suspected to be pregnant on clinical examination
- Known prisoners as defined in protocol
- Known ward of the state
- Isolated hanging, drowning or burns
- Previous enrollment in MATIC-2
- Prior study opt-out with bracelet
- Exclusion Criteria for the TXA/Placebo Domain
- Prehospital or pre-enrollment use of TXA
- Greater than 3 hours since time of injury
- History of seizure after the injury event
- Known allergy or hypersensitivity reaction to TXA
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06070350
Start Date
November 1 2024
End Date
October 1 2028
Last Update
March 28 2025
Active Locations (23)
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1
University of Arizona
Tucson, Arizona, United States, 84719
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
3
University of California Davis
Sacramento, California, United States, 95817
4
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010