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

NCT06070350

RecruitingPhase 3

Sponsor: Philip Spinella

Conditions: Hemorrhagic Shock, Trauma Injury

Interventions: Low Titer Group O Whole Blood (LTOWB), Placebo, Tranexamic Acid (TXA), Component Therapy (CT)

Countries: United States

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 overview

Sex: ALL

Age: — to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (23)
  • Tucson, Arizona, United States
  • Little Rock, Arkansas, United States
  • Sacramento, California, United States
  • Washington D.C., District of Columbia, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • New Orleans, Louisiana, United States
  • Jackson, Mississippi, United States
  • St Louis, Missouri, United States
  • Albuquerque, New Mexico, United States
  • Wake Forest, North Carolina, United States
  • Columbus, Ohio, United States
  • Portland, Oregon, United States
  • Pittsburgh, Pennsylvania, United States
  • Memphis, Tennessee, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • Salt Lake City, Utah, United States
  • Seattle, Washington, United States
  • Milwaukee, Wisconsin, United States