A group of researchers from UTHealth Houston School of Public Health (serving as the data coordinating center) in partnership with the clinical coordinating center at the University of Alabama at Birmingham (UAB), are launching a new five-year study of the effectiveness and safety of whole blood transfusions in trauma patients.
Funded by the National Heart Lung, and Blood Institute (NHLBI), the “Trauma Resuscitation with Group O Whole Blood Or Products” (TROOP) trial will enroll 1,200 patients at 12 trauma centers across the United States, to compare whole blood transfusions to blood component therapy, the current standard in trauma transfusions. Enrollment for TROOP will begin in spring 2023.
Trauma is the third leading cause of death in the United States. Importantly, it is the leading cause of death for children and adults under the age of 46, accounting for nearly half of all deaths in this age group. Together, injuries account for more years of potential life lost before age 75 than any other cause. Bleeding is responsible for 1/3 of trauma deaths, and 1/4 are thought to be preventable. Blood transfusion is an essential part of trauma resuscitation. The current standard of care in the resuscitation of severe hemorrhage in trauma patients is the balanced administration of blood components (red cells, plasma and platelets units).
Although the current standard of care in trauma transfusion is the balanced administration of separated blood components in a 1:1:1 configuration, emulating fresh whole blood, many U.S. trauma centers currently use unseparated blood (Low Titer Group O Whole Blood or LTOWB) for trauma resuscitation.
There are indications that whole blood transfusions may offer potential clinical and logistical advantages over component therapy. The advantages of whole blood over component therapy include its simplicity and lower potential for error, as well as reduced costs associated with the additional processing and storage of components.
Further, whole blood transfusions are increasingly being used in trauma centers, despite a lack of well-powered clinical trials. Thus, the renewed approach to blood transfusion therapy in trauma is to use whole blood from the outset. The greatest disadvantage to the widespread use of whole blood is a lack of multi-center randomized studies that have compared the strategies directly, which the TROOP multicenter trial of 1,200 trauma patients will evaluate.
The TROOP trial hypothesizes that the group treated with whole blood will be non-inferior to component therapy (that is equally effective) with respect to mortality at six hours post randomization. If whole blood is deemed to be non-inferior to component therapy, investigators will present the probability that whole blood is superior to component therapy. Additional secondary evaluations will determine the safety of whole blood at longer endpoints after transfusion: 24 hours, 30 days, as well as safety with respect to onset of major complications.
The trial will use an innovative, Bayesian, group-sequential, combined non-inferiority/superiority design. The trial has been designed in collaboration with NHLBI’s Innovative Clinical Trials Resource, funded by a U34 Planning Grant (U34HL148472).
The clinical coordinating center for the TROOP trial will be hosted at the University of Alabama at Birmingham, while the data coordinating center will be hosted at UTHealth Houston’s Coordinating Center for Clinical Trials (CCCT). The team from UTHealth Houston is led by Stacia DeSantis, PhD, professor of biostatistics, Department of Biostatistics and Data Science at the School of Public Health, and includes Bayesian statisticians and trialists Luis Leon Novelo, PhD, associate professor of biostatistics at the School of Public Health, and Claudia Pedroza, PhD, associate professor with the Department of Pediatrics at McGovern Medical School, along with a team of CCCT project coordinators and programmers.