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

Description

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.

Conditions

Hemorrhagic Shock, Trauma Injury

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Hemorrhagic Shock
Intervention / Treatment

-

Contacts and Locations

Tucson

University of Arizona, Tucson, Arizona, United States, 84719

Little Rock

Arkansas Children's Hospital, Little Rock, Arkansas, United States, 72202

Sacramento

University of California Davis, Sacramento, California, United States, 95817

Washington

Children's National Hospital, Washington, District of Columbia, United States, 20010

Atlanta

Emory University-Arthur M. Blank Hospital, Atlanta, Georgia, United States, 30329

Atlanta

Emory University-Scottish Rite Hospital, Atlanta, Georgia, United States, 30342

New Orleans

Tulane School of Medicine, New Orleans, Louisiana, United States, 70118

Jackson

University of Mississippi Medical Center, Jackson, Mississippi, United States, 39216

Saint Louis

Washington University of St. Louis, Saint Louis, Missouri, United States, 63110

Albuquerque

University of New Mexico, Albuquerque, New Mexico, United States, 87131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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).
  • 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
  • 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

Ages Eligible for Study

to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Philip Spinella,

Philip C Spinella, MD, PRINCIPAL_INVESTIGATOR, Univesrity of Pittsburgh

Study Record Dates

2028-10-01