Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children

Launched by PHILIP SPINELLA · Sep 29, 2023

Keywords

ClinConnect Summary

The MATIC-2 clinical trial is studying how effective certain treatments are for children under 18 years old who are experiencing severe bleeding due to traumatic injuries. The trial is comparing the use of Low Titer Group O Whole Blood (a type of blood transfusion) with standard blood component therapy, as well as Tranexamic Acid (a medication that helps reduce bleeding) with a placebo (a harmless substance with no medical effect). The main goal is to see if these treatments can lower the risk of death within the first 24 hours after a serious injury.

To be eligible for the trial, children must have a traumatic injury and show signs of life-threatening bleeding, such as very low blood pressure or a fast heartbeat. Some children may not qualify if they have certain severe injuries or if specific medical conditions apply. Participants in the trial will receive either the new treatments or standard care, and their health will be closely monitored. This trial is important because it aims to find better ways to save lives in children facing life-threatening bleeding after trauma.

Gender

ALL

Eligibility criteria

• 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