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RECRUITING
NCT06070350
PHASE3

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

Sponsor: Philip Spinella

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - 17 Years

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2024-11-01

Completion Date

2028-10-01

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

BIOLOGICAL

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.

DRUG

Placebo

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

DRUG

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).

BIOLOGICAL

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

Locations (23)

University of Arizona

Tucson, Arizona, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

University of California Davis

Sacramento, California, United States

Children's National Hospital

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

Emory University-Arthur M. Blank Hospital

Atlanta, Georgia, United States

Emory University-Scottish Rite Hospital

Atlanta, Georgia, United States

Tulane School of Medicine

New Orleans, Louisiana, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Washington University of St. Louis

St Louis, Missouri, United States

University of New Mexico

Albuquerque, New Mexico, United States

Wake Forest University Health Sciences

Wake Forest, North Carolina, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

LeBonheur Children's Hospital

Memphis, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Children's Memorial Hermann Hospital

Houston, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

University of Washington Harborview

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States