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NCT05638581 · ClinicalTrials.gov registry record · Phase 3
Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
A Phase 3 study of Wounds and Injuries and Shock, Hemorrhagic, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,100
- Enrollment target
- 13
- Study locations
NCT05638581: Recruiting Phase 3 study of Wounds and Injuries and Shock, Hemorrhagic, sponsored by University of Alabama at Birmingham.
NCT05638581 is a Phase 3 study of Wounds and Injuries and Shock, Hemorrhagic that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 1,100 participants, above the 463-participant average among 27 other Wounds and Injuries trials with a reported enrollment target (138% higher). The trial reports 13 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05638581, a Phase 3 study of Wounds and Injuries and Shock, Hemorrhagic, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,100 participants
- Enrollment target
- 13
- Study locations
Study 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.
Primary Outcome
Participant vital status at 6-hours following randomization (randomization defined as product container is opened for administration to participant)
Conditions Studied
Interventions
- BIOLOGICAL LTOWB
- BIOLOGICAL Components
Study Locations (13)
Texas
- University of Texas Health Science Center Houston - Houston
- University of Texas Health San Antonio and University Health System - San Antonio
Alabama
- University of Alabama at Birmingham, UAB Hospital - Birmingham
California
- Los Angeles County + University of Southern California (LAC + USC) Medical Center - Los Angeles
Louisiana
- University Medical Center New Orleans LCMC Health - New Orleans
Maryland
- University of Maryland Medical Center - Baltimore
Missouri
- Washington University School of Medicine - St Louis
North Carolina
- Atrium Health Wake Forest Baptist - Winston-Salem
Ohio
- University of Cincinnati Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,100 participants |
| Start Date | 2023-07-27 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 3 |
What NCT05638581 shows while recruiting
NCT05638581 is an interventional study that assigns participants to a tested intervention. Its 1,100 participants enrollment target places it among the larger protocols in the corpus, above the 463-participant average among 27 other Wounds and Injuries trials with a reported enrollment target (138% higher).
The record links to 2 conditions, with Wounds and Injuries appearing as the primary indexed condition, and to 2 interventions - of which LTOWB is the first listed.
NCT05638581 lists 13 locations in 12 states (Texas, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT05638581 about?
NCT05638581 is a clinical study titled "Trauma Resuscitation With Low-Titer Group O Whole Blood or Products". 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 b...
What is the current status of trial NCT05638581?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,100 participants. The study started on 2023-07-27. Estimated completion is 2027-06-30.
What conditions does trial NCT05638581 study?
This clinical trial studies the following conditions: Wounds and Injuries, Shock, Hemorrhagic.
What interventions are being tested in trial NCT05638581?
The interventions under investigation include: LTOWB (BIOLOGICAL), Components (BIOLOGICAL).
Who is sponsoring clinical trial NCT05638581?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05638581 being conducted?
This trial has 13 study locations across Alabama, California, Louisiana, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Wounds and Injuries
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05638581's enrollment target sits among peer trials
1,100 3rd of 27 higher than 25 of 27 other Wounds and Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Wounds and Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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