U24HL157310

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

In collaboration with the University of Alabama (UAB), we propose to conduct the five-year "Trauma Resuscitation with Group O Whole Blood or Products" (TROOP) trial. This trial is a pragmatic, multicenter, phase III randomized clinical trial aimed at evaluating the clinical effectiveness and safety of whole blood compared with component blood therapy in trauma patients predicted to require large volume blood transfusions.

The primary hypothesis of the TROOP trial is that the group treated with whole blood will exhibit no worse mortality and/or lower mortality compared to component therapy at 6 hours. The rationale for this trial is that although 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), 123 U.S. trauma centers currently use low-titer group O whole blood (LTOWB) for trauma resuscitation. Thus, a renewed approach to blood transfusion therapy in trauma is to use whole blood from the outset. Compared with component therapy, transfusion with whole blood offers several logistical and potentially clinical advantages. However, there are only a small number of observational studies that have compared the strategies.

The specific aims of the TROOP trial clinical coordinating center (CCC) application submitted by UAB are to: (1) determine the effectiveness of whole blood versus component therapy at 6 hours in critically injured patients, and (2) evaluate the safety of whole blood compared to component therapy by evaluating longer-term endpoints: 24 hours, 30 days, and major complications. To assess these specific aims, the trial uses a highly innovative, Bayesian, group-sequential, combined non-inferiority/superiority design, and pre-planned cost-effectiveness analysis. The trial has been designed in collaboration with NHLBI's Innovative Clinical Trials Resource, funded by a U34 planning grant (U34HL148472).

The accompanying CCC application from UAB describes the details of the clinical background and rationale for the study, eligibility criteria, treatment and follow-up procedures, and the organizational structure of TROOP. The coordinating center for clinical trials in the Department of Biostatistics and Data Science at the University of Texas Health Science Center at Houston will serve as the statistical and data coordination center (DCC) for the TROOP trial. This DCC application describes the TROOP trial aims, expertise of the DCC, its role in the TROOP trial, details of data processing and management, and details of the Bayesian statistical design, analysis plan, and potential pitfalls.

University Of Texas Health Science Center At Houston

THE DIVISION OF BLOOD DISEASES AND RESOURCES SUPPORTS RESEARCH AND RESEARCH TRAINING ON THE PATHOPHYSIOLOGY, DIAGNOSIS, TREATMENT, AND PREVENTION OF NON-MALIGNANT BLOOD DISEASES, INCLUDING ANEMIAS, SICKLE CELL DISEASE, THALASSEMIA, LEUKOCYTE BIOLOGY, PRE-MALIGNANT PROCESSES SUCH AS MYELODYSPLASIA AND MYELOPROLIFERATIVE DISORDERS, HEMOPHILIA AND OTHER ABNORMALITIES OF HEMOSTASIS AND THROMBOSIS, AND IMMUNE DYSFUNCTION. FUNDING ENCOMPASSES A BROAD SPECTRUM OF HEMATOLOGIC INQUIRY, RANGING FROM STEM CELL BIOLOGY TO MEDICAL MANAGEMENT OF BLOOD DISEASES AND TO ASSURING THE ADEQUACY AND SAFETY OF THE NATION'S BLOOD SUPPLY. PROGRAMS ALSO SUPPORT THE DEVELOPMENT OF NOVEL CELL-BASED THERAPIES TO BRING THE EXPERTISE OF TRANSFUSION MEDICINE AND STEM CELL TECHNOLOGY TO THE REPAIR AND REGENERATION OF HUMAN TISSUES AND ORGANS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, USE SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY SOCIALLY AND ECONOMICALLY DISADVANTAGED PERSONS, AND INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE R&D BETWEEN SMALL BUSINESSES AND RESEARCH INSTITUTIONS, AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL R&D.

93.837 - Cardiovascular Diseases Research

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

Houston, Texas 770303870 United States

Single Zip Code

Data Coordinating Center for Multi-Site Investigator-Initiated Clinical Trials (Collaborative U24 Clinical Trial Required) (PAR-19-330)

Amendment Since initial award the End Date has been extended from 07/31/23 to 07/31/27 and the total obligations have increased 266% from $653,807 to $2,395,733.