MATIC-2Massive Transfusion in Children: a Platform RCT of Whole Blood Compared to Component Therapy and Tranexamic Acid to Placebo in Life-threatening Traumatic Bleeding

Fecha de inicio: 1 de noviembre de 2024

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