# 2/2 Trauma Resuscitation with Group O Whole Blood or Products (TROOP)

> **NIH NIH U24** · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · 2024 · $561,796

## Abstract

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, 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.
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 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.

## Key facts

- **NIH application ID:** 10925333
- **Project number:** 5U24HL157310-03
- **Recipient organization:** UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
- **Principal Investigator:** Stacia DeSantis
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $561,796
- **Award type:** 5
- **Project period:** 2022-08-05 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10925333

## Citation

> US National Institutes of Health, RePORTER application 10925333, 2/2 Trauma Resuscitation with Group O Whole Blood or Products (TROOP) (5U24HL157310-03). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10925333. Licensed CC0.

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