1,000
Participants
Start Date
November 1, 2024
Primary Completion Date
June 1, 2028
Study Completion Date
October 1, 2028
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
RECRUITING
Children's Hospital of Pittsburgh of UPMC, Pittsburgh
RECRUITING
Children's National Hospital, Washington D.C.
RECRUITING
Wake Forest University Health Sciences, Wake Forest
RECRUITING
Emory University-Arthur M. Blank Hospital, Atlanta
RECRUITING
Emory University-Scottish Rite Hospital, Atlanta
NOT_YET_RECRUITING
Vanderbilt University Medical Center, Nashville
RECRUITING
LeBonheur Children's Hospital, Memphis
RECRUITING
University of Mississippi Medical Center, Jackson
RECRUITING
Nationwide Children's Hospital, Columbus
RECRUITING
Medical College of Wisconsin, Milwaukee
RECRUITING
Washington University of St. Louis, St Louis
RECRUITING
Tulane School of Medicine, New Orleans
RECRUITING
Arkansas Children's Hospital, Little Rock
RECRUITING
The University of Texas Southwestern Medical Center, Dallas
RECRUITING
Baylor College of Medicine, Houston
RECRUITING
Children's Memorial Hermann Hospital, Houston
RECRUITING
University of Texas Health Science Center at San Antonio, San Antonio
RECRUITING
Primary Children's Hospital, Salt Lake City
RECRUITING
University of Arizona, Tucson
RECRUITING
University of New Mexico, Albuquerque
RECRUITING
University of California Davis, Sacramento
RECRUITING
Oregon Health and Science University, Portland
RECRUITING
University of Washington Harborview, Seattle
Biomedical Advanced Research and Development Authority
FED
Philip Spinella
OTHER