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Blood Product
Whole Blood vs Component Transfusion for Severe Injuries (TROOP Trial)
Phase 3
Recruiting
Led By Jan Jansen, MBBS, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30-days post randomization
Awards & highlights
TROOP Trial Summary
This trial compares whole blood transfusions to separate blood components to see which works better for critically injured patients.
Who is the study for?
This trial is for adults over 15 years old or weighing more than 50 kg with major bleeding from trauma and needing a lot of blood fast. They should be directly taken to a trauma center and not have received too much blood already. It's not for kids under 15, prisoners, those who've had certain emergency procedures, refuse blood products, are visibly pregnant or known to be so.Check my eligibility
What is being tested?
The study compares two ways of giving blood during emergencies: Low-Titer Group O Whole Blood (LTOWB), which is unseparated, versus separate components like red cells and plasma. The aim is to see which method works better in severe injury cases requiring massive transfusions.See study design
What are the potential side effects?
Possible side effects include reactions similar to any large-volume blood transfusion such as allergic reactions, fever, lung injury related to transfusion (TRALI), iron overload in the body if many transfusions are given over time, and infections transmitted through the blood.
TROOP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30-days post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30-days post randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6-hour Mortality
Secondary outcome measures
24-hour Mortality
Adjudicated Primary Cause of Death
Discharge destination
+9 moreTROOP Trial Design
2Treatment groups
Active Control
Group I: LTOWBActive Control1 Intervention
Participants randomized to receive (Low Titer O Whole Blood [LTOWB])
Group II: ComponentsActive Control1 Intervention
Participants randomized to receive the component blood products.
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
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2,280,562 Total Patients Enrolled
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an adult or weigh more than 50 kg if my age is unknown.I needed emergency chest surgery or had CPR for more than 5 minutes before getting blood products.I am under 15 years old.I have received more than two blood transfusions or equivalent treatments.Over 20% of my body has been burned.I have been part of a major bleeding emergency treatment plan.I have started receiving blood transfusions.I refuse to receive blood products.I have a traumatic injury with major bleeding or a high risk of it.
Research Study Groups:
This trial has the following groups:- Group 1: LTOWB
- Group 2: Components
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned the use of LTOWB for medicinal purposes?
"The safety of LTOWB was appraised to be a 3 as per our team's assessment at Power. This is because this experiment has already reached the third stage, thereby giving us evidence that it can yield effective results while remaining secure."
Answered by AI
How many locations are currently hosting this trial?
"Currently, 12 medical centres are enrolling participants in this investigation. These facilities can be found in Winston-Salem, Portland and Cincinnati as well as several other nearby locales. It is vital to select the closest site for maximum convenience if you choose to partake in this study."
Answered by AI
Are there any vacancies for enrolment in this trial?
"Unfortunately, the clinicaltrials.gov page does not indicate that this specific trial is actively accepting patients at present. It was first posted on April 15th 2023 and last updated November 28th 2022; however, there are 753 other studies currently in search of participants."
Answered by AI
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