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RECRUITING Phase 3

Trauma Resuscitation With Low-Titer Group O Whole Blood or Products

NCT05638581 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 1,100 participants
Start Date 2023-07-27
Est. Completion 2027-06-30
Phase Phase 3

Sponsor

University of Alabama at Birmingham

1,315 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05638581

The ClinicalTrials.gov registry entry for NCT05638581 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05638581 reports 13 study locations spanning 12 distinct geographic areas — top geographies include Texas, Alabama, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05638581?

The interventions under investigation include: LTOWB (BIOLOGICAL), Components (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05638581?

This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial