Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children
Massive Transfusion in Children: a Platform RCT of Whole Blood Compared to Component Therapy and Tranexamic Acid to Placebo in Life-threatening Traumatic Bleeding
Philip Spinella
1,000 participants
Nov 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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).
Exclusion Criteria13
- 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
- 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
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Interventions
LTOWB is whole blood from group O donors with low titer (\<200) anti-A and anti-B antibodies. Up to 8 units of LTOWB will be allowed unless local clinical practice allows for a higher maximum dose.
Placebo will be provided to the research pharmacy at each of the clinical sites
TXA is a synthetic lysine analog that competitively inhibit activation of plasminogen, thereby decreasing the conversion of plasminogen to plasmin, preventing degradation of fibrin's matrix structure. Dose is 25mg/kg IV or IO (maximum 2 grams).
Component Therapy (CT) will be RBCs, plasma and platelet units in a 1:1:1 unit ratio. This will be given with Placebo
Locations(23)
View Full Details on ClinicalTrials.gov
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NCT06070350