NCT05638581 · University of Alabama at Birmingham
Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
(TROOP)
What this study is about
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.
View original scientific description
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
Participants will receive Low Titer O Whole Blood administered intravenously or intraosseously.
BIOLOGICAL
Components
Participants will receive separated blood components (i.e., units of red cells, plasma, platelets, and cryoprecipitate) co-administered intravenously or intraosseously.
Primary outcome measures
6-hour Mortality
Time frame: First 6 hours after randomization
Participant vital status at 6-hours following randomization (randomization defined as product container is opened for administration to participant)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult trauma patient (estimated age \> 15 or weight \> 50 kg, if age unknown) 2. Patient taken to trauma center directly from scene 3. Commencement of blood transfusion (PRBC, plasma or LTOWB), in pre-hospital or in-hospital setting 4. Activation of site-specific Massive Hemorrhage Protocol or Massive Transfusion Protocol 5. Traumatic injury with at least one of the following: 1. Confirmed or suspected acute major bleeding 2. Assessment of Blood Consumption (ABC) Score ≥2
Exclusion criteria
- Patients who have received, prehospital or in-hospital more than two units of LTOWB; the equivalent in components (two units of packed red blood cells and two units of plasma); or a combination of the two (more than one unit of LTOWB, one unit of packed cells, and one unit of plasma). Most trauma centers hold two units of either packed red blood cells (with two units of plasma) or two units of LTOWB in the emergency department. This stock is used to initiate tran
Where
- Birmingham, Alabama
- Los Angeles, California
- New Orleans, Louisiana
- Baltimore, Maryland
- St Louis, Missouri
- Winston-Salem, North Carolina
- Cincinnati, Ohio
- Portland, Oregon
- Philadelphia, Pennsylvania
- Houston, Texas
- San Antonio, Texas
- Seattle, Washington
And 1 more location — see the full list below.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), The University of Texas Health Science Center, Houston
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2025 · Source of record for eligibility and locations