Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
Start Date
7/27/2023
Completion Date
6/30/2027
Summary
The goal of this clinical trial is to compare the effectiveness of unseparated whole blood (referred to as Low-Titer Group O Whole Blood) and the separate components of whole blood (including red cells, plasma, platelets, and cryoprecipitate) in critically injured patients who require large-volume blood transfusions.
Detailed Description
Trauma is one of the leading causes of death in the United States, and disproportionately affects the young, killing those who might otherwise have lived long and productive lives. Injuries account for more years of potential life lost before age 75 than any other cause. Hemorrhage remains the most common cause of preventable death after injury, and blood transfusion is an essential part of treatment. Modern blood banking practices separate donated whole blood into components. The current standard of care in trauma transfusion is the balanced administration of equal numbers of units of blood components (packed red blood cells, plasma, and platelets), effectively attempting to reconstitute whole blood. A renewed approach to blood transfusion therapy in trauma is to use whole blood from the outset, which has not been separated. Compared with component therapy, whole blood offers several potential advantages, but there are only a small number of, mostly observational, studies comparing whole blood and component therapy, and they are very heterogeneous. The TROOP trial will include injured adults with hemorrhagic shock anticipated to require massive blood transfusions, who will be randomized to receive either whole blood (LTOWB) or blood components. This will allow a direct comparison to see if one type of transfusion is more strongly associated with improved clinical outcomes over the other. The knowledge gained from this clinical trial will transform the way in which massively bleeding trauma patients are transfused. The trial is exceedingly well positioned to improve mortality from trauma and reduce the number of preventable deaths resulting from hemorrhagic shock.
Eligibility Criteria
Age Range: 15 years to No maximum
Interventions
LTOWB
Components
Conditions
Locations
University of Alabama at Birmingham, UAB Hospital
Birmingham, Alabama 35294
United States
Los Angeles County + University of Southern California (LAC + USC) Medical Center
Los Angeles, California 90033
United States
University Medical Center New Orleans LCMC Health
New Orleans, Louisiana 70112
United States
University of Maryland Medical Center
Baltimore, Maryland 21201
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157
United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45267
United States
Oregon Health and Sciences University Hospital
Portland, Oregon 97239
United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania 19104
United States
University of Texas Health Science Center Houston
Houston, Texas 77030
United States
University of Texas Health San Antonio and University Health System
San Antonio, Texas 78229
United States
Harborview Medical Center
Seattle, Washington 98104
United States
Froedtert Hospital
Milwaukee, Wisconsin 53226
United States