# 1/2 Trauma Resuscitation with Group O Whole Blood Or Products (TROOP) Trial

> **NIH NIH UG3** · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 2022 · $1,680,442

## Abstract

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.

## Key facts

- **NIH application ID:** 10449760
- **Project number:** 1UG3HL157401-01A1
- **Recipient organization:** UNIVERSITY OF ALABAMA AT BIRMINGHAM
- **Principal Investigator:** John B Holcomb
- **Activity code:** UG3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,680,442
- **Award type:** 1
- **Project period:** 2022-08-05 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10449760

## Citation

> US National Institutes of Health, RePORTER application 10449760, 1/2 Trauma Resuscitation with Group O Whole Blood Or Products (TROOP) Trial (1UG3HL157401-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10449760. Licensed CC0.

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