Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children (NCT06070350) | Clinical Trial Compass
RecruitingPhase 3
Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children
United States1,000 participantsStarted 2024-11-01
Plain-language 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 clinical trial is to determine the effectiveness of Low Titer Group O Whole Blood (LTOWB) compared to component therapy (CT), and Tranexamic Acid (TXA) compared to placebo in decreasing 24-hour all-cause mortality in children with traumatic life threatening hemorrhage.
Who can participate
Age range17 Years
SexALL
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Inclusion criteria
✓. Children, defined as less than estimated18 years of age with traumatic injury
✓. MTP activation for confirmed or suspected active life-threatening traumatic bleeding
✓. 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).
Exclusion criteria
✕. 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