Recruiting

Phase 3

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

Sponsor:

Philip Spinella

Code:

NCT06070350

Conditions

Hemorrhagic Shock

Trauma Injury

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Low Titer Group O Whole Blood (LTOWB)

Placebo

Tranexamic Acid (TXA)

Component Therapy (CT)

Study Details

Brief summary:

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

Study ID

NCT06070350

Start date

Nov 1, 2024

Status verified date

Jul, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Group 1 (LTOWB+TXA)

Concurrent administration of LTOWB and TXA

other: Group 2 (LTOWB+Placebo)

Concurrent administration of LTOWB and Placebo

other: Group 3 (CT+TXA)

Concurrent administration of CT and TXA

other: Group 4 (CT+Placebo)

Concurrent administration of CT and Placebo

Interventions

Low Titer Group O Whole Blood (LTOWB)

LTOWB is whole blood from group O donors with low titer (<200) anti-A and anti-B antibodies. Up to 8 units of LTOWB will be allowed unless local clinical practice allows for a higher maximum dose.

Placebo

Placebo will be provided to the research pharmacy at each of the clinical sites

Tranexamic Acid (TXA)

TXA is a synthetic lysine analog that competitively inhibit activation of plasminogen, thereby decreasing the conversion of plasminogen to plasmin, preventing degradation of fibrin's matrix structure. Dose is 25mg/kg IV or IO (maximum 2 grams).

Component Therapy (CT)

Component Therapy (CT) will be RBCs, plasma and platelet units in a 1:1:1 unit ratio. This will be given with Placebo

Primary outcome measure

24 hours all cause mortality [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Thomas Byers

412-383-2340 tdb33@pitt.edu

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 84719

Principal Investigator:

Louis Magnotti, MD

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202

Principal Investigator:

Todd Maxson, MD

University of California Davis

Recruiting

Sacramento, California, United States, 95817

Principal Investigator:

Daniel Nishijima, MD

Children's National Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Principal Investigator:

Randall Burd, MD

Emory University-Arthur M. Blank Hospital

Recruiting

Atlanta, Georgia, United States, 30329

Principal Investigator:

Ruth Hwu, MD

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Principal Investigator:

Matthew Kutcher, MD

Washington University of St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Principal Investigator:

Lindsay Clukies, MD

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87131

Principal Investigator:

Sarah Moore, MD

Wake Forest University Health Sciences

Recruiting

Wake Forest, North Carolina, United States, 27157

Principal Investigator:

Lucas Neff, MD

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Principal Investigator:

Julie Leonard, MD

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Principal Investigator:

Trisha Wong, MD

Children's Hospital of Pittsburgh of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Principal Investigator:

Ward Richardson, MD

LeBonheur Children's Hospital

Recruiting

Memphis, Tennessee, United States, 38103

Principal Investigator:

Regan Williams, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Adam Vogel, MD

Children's Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Charles Cox, MD

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Susannah Nicholson, MD

Primary Children's Hospital

Recruiting

Salt Lake City, Utah, United States, 84112

Principal Investigator:

Katie Russell, MD

University of Washington Harborview

Recruiting

Seattle, Washington, United States, 98195

Principal Investigator:

Bryce Robinson, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Principal Investigator:

Katherine Flynn-O'Brien, MD

More Information

Sponsor

Philip Spinella

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

Children
Pediatrics
Transfusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Philip Spinella on 2026-07-21.