Trauma Resuscitation With Low-Titer Group O Whole Blood or Products: Study Protocol for a Randomized Clinical Trial (the Troop Trial)

Authors

Jan O Jansen
Claudia Pedroza
Luis Leon Novelo
Tianyao Hao
Gina R DeWildt
Charles F Coton
Kiran Mansoor
Shannon W Stephens
Marisa B Marques
James R Stubbs
Jillian R Richter
Henry E Wang
John B Holcomb
Stacia M DeSantis

Language

English

Publication Date

8-2-2025

Journal

Trials

DOI

10.1186/s13063-025-08971-y

PMID

40753420

PMCID

PMC12318426

PubMedCentral® Posted Date

8-2-2025

PubMedCentral® Full Text Version

Post-print

Abstract

Background: Hemorrhage is the most common cause of potentially preventable death after injury. Balanced transfusion with red blood cells, plasma, and platelets (component therapy, CT) has been shown to reduce mortality, and is the standard of care. Low-Titer Group O Whole Blood (LTOWB) is an attractive alternative to CT, but existing evidence comprises observational studies, and a small single center pilot randomized controlled trial, which evaluated a type of whole blood that is no longer in use. The aim of the "Trauma Resuscitation with Low-Titer Group O Whole Blood Or Products" (TROOP) trial is to compare the effectiveness and safety of LTOWB and CT in critically injured patients predicted to require a large volume transfusion.

Methods: This is a pragmatic, multicenter, Bayesian, sequential non-inferiority/superiority, randomized clinical trial, performed within 15 level I trauma centers in the United States. We aim to randomize 1,100 injured patients to resuscitation with either CT or LTOWB. The primary outcome is 6-h mortality. Secondary outcomes include 24-h and 30-day or hospital mortality (whichever is earlier); prespecified complications; adjudicated cause of death; time to death; length of stay (ICU and hospital); and hospital-, ventilator- and ICU-free days; the incidence of major surgical procedures; time to hemostasis in those undergoing procedures with a hemostatic component; number and type of blood products used until hemostasis is achieved (and randomized products are discontinued), as well as after hemostasis has been achieved, to 24 h post-admission; discharge destination and functional status and quality of life at hospital discharge or 30 days, as measured by Glasgow Coma Scale (GCS) and EuroQol (EQ-5D) quality of life measurement.

Discussion: This large multicenter clinical trial will contribute high-level evidence on the effectiveness of Low-Titer Group O Whole Blood in the in-hospital management of trauma patients predicted to require a large volume transfusion. Trial registration National Clinical Trial Identified Number: NCT05638581.

Keywords

Humans, ABO Blood-Group System, Bayes Theorem, Blood Transfusion, Equivalence Trials as Topic, Hemorrhage, Hospital Mortality, Multicenter Studies as Topic, Pragmatic Clinical Trials as Topic, Resuscitation, Time Factors, Trauma Centers, Treatment Outcome, United States, Wounds and Injuries, Trauma, Injury, Resuscitation, Low-Titer Group O Whole Blood, Component therapy, Trauma, Injury, Resuscitation, Low-Titer Group O Whole Blood, Component therapy

Comments

National Clinical Trial Identified Number: NCT05638581.

Clinical trial registry: https://clinicaltrials.gov/study/NCT05638581

Published Open-Access

yes

Recommended Citation

Jansen, Jan O; Pedroza, Claudia; Novelo, Luis Leon; et al., "Trauma Resuscitation With Low-Titer Group O Whole Blood or Products: Study Protocol for a Randomized Clinical Trial (the Troop Trial)" (2025). Faculty, Staff and Student Publications. 1187.
https://digitalcommons.library.tmc.edu/uthsph_docs/1187