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New treatment option for Wounds and Injuries
Official title Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
ClinicalTrials.gov ID: NCT05638581
What this study is testing
What is LTOWB?
LTOWB is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for wounds and injuries.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 and older
You may be able to join if
- Adult trauma patient (estimated age \> 15 or weight \> 50 kg, if age unknown)
- Patient taken to trauma center directly from scene
- Commencement of blood transfusion (PRBC, plasma or LTOWB), in pre-hospital or in-hospital setting
- Activation of site-specific Massive Hemorrhage Protocol or Massive Transfusion Protocol
- Traumatic injury with at least one of the following:
You likely can't join if
- Patients who have received, prehospital or in-hospital more than two units of LTOWB; the equivalent in components (two units of packed red blood...
- Patients transferred from another hospital
- Children \<15 years (in most communities, patients aged 15-18 years are treated at adult trauma centers, and patients in this age group frequently...
- Known prisoners, defined as individuals involuntarily confined or detained in a penal institution (including juvenile detention, involuntary...
- Moribund patients expected to die within 1 hour
- Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving assigned by...
See the full eligibility criteria
- Adult trauma patient (estimated age \> 15 or weight \> 50 kg, if age unknown)
- Patient taken to trauma center directly from scene
- Commencement of blood transfusion (PRBC, plasma or LTOWB), in pre-hospital or in-hospital setting
- Activation of site-specific Massive Hemorrhage Protocol or Massive Transfusion Protocol
- Traumatic injury with at least one of the following:
- Confirmed or suspected acute major bleeding
- Assessment of Blood Consumption (ABC) Score ≥2
- 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...
- Patients transferred from another hospital
- Children \<15 years (in most communities, patients aged 15-18 years are treated at adult trauma centers, and patients in this age group frequently suffer life-threatening injuries, and will therefore be included)
- Known prisoners, defined as individuals involuntarily confined or detained in a penal institution (including juvenile detention, involuntary psychiatric commitment, or court-ordered residential substance abuse treatment)
- Moribund patients expected to die within 1 hour
- Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving assigned by chance blood products)
- Patients with known "do not resuscitate" orders prior to randomization
- Patients who refuse the administration of blood products
- Individuals with a research "opt out" bracelet.
- Greater than 20% total body surface area (TBSA) burns
- Suspected inhalation injury victims
- Patients who are obviously pregnant on clinical examination or known to be pregnant as provided by the subject or legally authorized representative
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- St Louis, Missouri, United States
- Winston-Salem, North Carolina, United States
- Cincinnati, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; New Orleans, Louisiana, United States; Baltimore, Maryland, United States; St Louis, Missouri, United States; Winston-Salem, North Carolina, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.