UG3HL157401

1/2 Trauma Resuscitation with Group O Whole Blood or Products (TROOP) Trial - Project Summary

This application is for the "Trauma Resuscitation with Group O Whole Blood or Products" (TROOP) trial, a pragmatic, multicenter, Phase III randomized clinical trial to evaluate the clinical effectiveness and safety of whole blood, compared with component blood therapy, in trauma patients predicted to require large volume blood transfusions.

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 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.

TROOP will randomly assign eligible patients to either whole blood resuscitation or component therapy (the current standard of care). The trial uses a highly 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). In keeping with recent expert recommendations, the primary outcome will be 6-hour mortality.

TROOP will enroll 1,100 patients over 36 months at 12 Level I trauma centers. The trial will have 85% power to determine non-inferiority and 80% power to determine superiority. We have assembled a highly experienced team of investigators with significant and complementary expertise in this type of research. The clinical coordinating center is based in the Center for Injury Science at the University of Alabama at Birmingham, and the data coordinating center is based in the School of Public Health at the University of Texas Health Science Center at Houston.

The knowledge gained from this clinical trial will transform the way in which massively bleeding trauma patients are transfused. TROOP is exceedingly well positioned to improve mortality from trauma and reduce the number of preventable deaths resulting from hemorrhagic shock.

University Of Alabama At Birmingham

NOT APPLICABLE

93.837 - Cardiovascular Diseases Research

National Heart Lung and Blood Institute (NHLBI) [HHS - NIH]

Birmingham, Alabama 352331912 United States

Single Zip Code

Clinical Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required) (PAR-19-329)

Amendment Since initial award the total obligations have decreased 68% from $1,680,442 to $538,105.