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Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children
Sponsor: Philip Spinella
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
Conditions
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
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