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

Phase 3

Not yet recruiting

• Conditions: Trauma Injury; Hemorrhagic Shock

• Registration Number: NCT06070350
• Lead Sponsor: Philip Spinella

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-9-27
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

General Inclusion Criteria:<br><br> 1. Children, defined as less than estimated18 years of age with traumatic injury<br><br> 2. MTP activation for confirmed or suspected active life-threatening traumatic bleeding<br><br>AND<br><br>Confirmed or suspected active life-threatening traumatic bleeding with at least 2 of 3 of<br>the following criteria:<br><br> 1. Hypotension for age (< 5% tile)<br><br> 2. Tachycardia for age (>95th % tile)<br><br> 3. Traumatic injury with exam findings consistent with severe bleeding (e.g.,<br> penetrating injury, hemothorax, distended abdomen with bruising, amputation of<br> limb).<br><br>General Exclusion Criteria:<br><br> 1. Patient with devastating traumatic brain injury not expected to survive due to<br> magnitude of injury (example: Transhemispheric gunshot wound with signs of<br> herniation, GCS score of 3 with fixed and dilated pupils)<br><br> 2. MTP activated but no blood products given<br><br> 3. Patients who required an ED thoracotomy or received more than 5 consecutive minutes<br> of cardiopulmonary resuscitation (prior to receiving randomized blood products)<br><br> 4. Patients who are known or suspected to be pregnant on clinical examination<br><br> 5. Known prisoners as defined in protocol<br><br> 6. Known ward of the state<br><br> 7. Isolated hanging, drowning or burns<br><br> 8. Previous enrollment in MATIC-2<br><br> 9. Prior study opt-out with bracelet<br><br>Exclusion Criteria for the TXA/Placebo Domain<br><br> 1. Prehospital or pre-enrollment use of TXA<br><br> 2. Greater than 3 hours since time of injury<br><br> 3. History of seizure after the injury event<br><br> 4. Known allergy or hypersensitivity reaction to TXA

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
24 hours all cause mortality

Secondary Outcome Measures

Name	Time	Method
6-hour, 72-hour and 28-day survival;24 hours total blood product transfusion volumes