drugset / Trial / NCT05638581
Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
Phase 3
Recruiting
1100 enrolled
University of Alabama at Birmingham
National Heart, Lung, and Blood Institute (NHLBI) · collabThe University of Texas Health Science Center, Houston · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The goal of this clinical trial is to compare the effectiveness of unseparated whole blood (referred to as Low-Titer Group O Whole Blood) and the separate components of whole blood (including red cells, plasma, platelets, and cryoprecipitate) in critically injured patients who require large-volume blood transfusions.
Timeline
- Start
- 2023-07-27
- Primary completion
- 2026-12-31
- Completion
- 2027-06-30
Publications
- Jansen JO, Pedroza C, Novelo LL, Hao T, DeWildt GR, Coton CF, Mansoor K, Stephens SW, Marques MB, Stubbs JR, Richter JR, Wang HE, Holcomb JB, DeSantis SM. Trauma resuscitation with Low-Titer Group O Whole Blood Or Products: study protocol for a randomized clinical trial (the TROOP trial). Trials. 2025 Aug 2;26(1):266. doi: 10.1186/s13063-025-08971-y.
- Meizoso JP, Cotton BA, Lawless RA, Kodadek LM, Lynde JM, Russell N, Gaspich J, Maung A, Anderson C, Reynolds JM, Haines KL, Kasotakis G, Freeman JJ. Whole blood resuscitation for injured patients requiring transfusion: A systematic review, meta-analysis, and practice management guideline from the Eastern Association for the Surgery of Trauma. J Trauma Acute Care Surg. 2024 Sep 1;97(3):460-470. doi: 10.1097/TA.0000000000004327. Epub 2024 Mar 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cryoprecipitate | Protein / enzyme biologic | — | Intravenous |
| Comparator | Low-Titer Group O Whole Blood | Unknown | — | Intravenous |
| Subject | Plasma | Other / unclassified | — | Intravenous |
| Subject | Platelets | Other / unclassified | — | Intravenous |
| Subject | red cells | Unknown | — | Intravenous |
Indications
No indication recorded.