Whole Blood vs Component Transfusion for Severe Injuries
(TROOP Trial)
Recruiting in Palo Alto (17 mi)
+13 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: University of Alabama at Birmingham
Disqualifiers: Prisoners, Moribund, DNR orders, Pregnancy, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of this treatment for severe injuries?
Research shows that using low-titer group O whole blood (LTOWB) in trauma patients, including children, is safe and can improve survival rates. It has been found to be as effective as conventional component therapy, with no significant differences in outcomes.
12345Is low-titer group O whole blood safe for transfusions?
Research shows that low-titer group O whole blood (LTOWB) is generally safe for use in both adults and children, with no significant difference in outcomes compared to traditional blood component therapy.
23567How is the treatment of Low-Titer Group O Whole Blood different from other treatments for severe injuries?
Low-Titer Group O Whole Blood (LTOWB) is unique because it provides all the components of blood (red blood cells, plasma, and platelets) in one transfusion, simplifying logistics and potentially improving outcomes for patients with severe injuries compared to the traditional method of giving separate blood components.
24789Eligibility Criteria
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.Inclusion Criteria
I am an adult or weigh more than 50 kg if my age is unknown.
Patient taken to trauma center directly from scene
I have been part of a major bleeding emergency treatment plan.
+2 more
Exclusion Criteria
Patients transferred from another hospital
I needed emergency chest surgery or had CPR for more than 5 minutes before getting blood products.
Individuals with a research 'opt out' bracelet
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants are randomized to receive either Low-Titer Group O Whole Blood or blood components for transfusion
Up to 30 days
Continuous monitoring during hospital stay
Follow-up
Participants are monitored for safety and effectiveness after treatment
30 days post randomization
Outcome Assessment
Assessment of secondary outcomes such as complications, functional status, and quality of life
From randomization to hospital discharge or 30-days post randomization
Participant Groups
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.
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.
Components is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Blood Components for:
- Anemia
- Thrombocytopenia
- Platelet function disorders
- Bleeding disorders
- Massive transfusion
🇺🇸 Approved in United States as Blood Components for:
- Anemia
- Thrombocytopenia
- Platelet function disorders
- Bleeding disorders
- Massive transfusion
🇨🇦 Approved in Canada as Blood Components for:
- Anemia
- Thrombocytopenia
- Platelet function disorders
- Bleeding disorders
- Massive transfusion
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Washington University School of MedicineSt. Louis, MO
Harborview Medical CenterSeattle, WA
Washington University School of MedicineSaint Louis, MO
University of Texas Health Science Center HoustonHouston, TX
More Trial Locations
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
The University of Texas Health Science Center, HoustonCollaborator
References
Injured recipients of low-titer group O whole blood have similar clinical outcomes compared to recipients of conventional component therapy: A single-center, retrospective study. [2021]Low-titer group O whole blood (LTOWB) is being increasingly transfused to injured patients. This study evaluated a range of clinical outcomes to determine if receipt of LTOWB predisposed recipients to worse outcomes compared to recipients of conventional component therapy (CCT).
Outcomes of Cold-Stored, Low-Titer Group O Whole Blood Transfusions in Nontrauma Massive Transfusion Protocol Activations. [2023]The use of low-titer group O whole blood (LTOWB) in military and civilian trauma centers shows no significant difference in outcomes compared with component therapy.
An assessment of the safety, hemostatic efficacy, and clinical impact of low-titer group O whole blood in children and adolescents. [2023]Low-titer group O whole blood (LTOWB) use has been associated with improved survival and less blood transfusions in adult trauma patients. Its use in pediatric trauma has been shown to be safe when using leukoreduced, LTOWB with anti-A, anti-B antibody titers of
Survey to inform trial of low-titer group O whole-blood compared to conventional blood components for children with severe traumatic bleeding. [2021]Low-titer group O whole-blood (LTOWB) is being used for children with life-threatening traumatic bleeding. A survey was conducted to determine current LTOWB utilization and interest in participation in a randomized control trial (RCT) of LTOWB versus standard blood component transfusion in this population.
Low Titer Group O Whole Blood In Injured Children Requiring Massive Transfusion. [2023]The aim of this study was to assess the survival impact of low-titer group O whole blood (LTOWB) in injured pediatric patients who require massive transfusion.
Adverse events after low titer group O whole blood versus component product transfusion in pediatric trauma patients: A propensity-matched cohort study. [2021]Low titer group O whole blood (LTOWB) is used as the initial resuscitative fluid in an increasing number of pediatric trauma and massive bleeding transfusion protocols. There is little data on adverse events following its transfusion in pediatric trauma patients.
The Dead Sea needs salt water… massively bleeding patients need whole blood: The evolution of blood product resuscitation. [2020]Whole blood, that is blood that is not manufactured into its component red blood cells (RBC) plasma, and platelets (PLT) units, was the mainstay of transfusion for many years until it was discovered that the component parts of a blood donation could be stored under different conditions thereby optimizing the storage length of each product. The use of low anti-A and -B titer group O whole blood (LTOWB) has recently been rediscovered for use in massively bleeding trauma patients. Whole blood has several advantages over conventional component therapy for these patients, including simplifying the logistics of the resuscitation, being more concentrated than whole blood that is reconstituted from conventional components, and providing cold-stored PLTs, amongst other benefits. While randomized controlled trials to determine the efficacy of using LTOWB in the resuscitation of massively bleeding trauma patients are currently underway, retrospective data has shown that massively bleeding recipients of LTOWB with traumatic injury do not have worse outcomes compared to patients who received conventional components and, in some cases, recipients of LTOWB have more favourable outcomes. This paper will describe some of the advantages of using LTOWB and will discuss the emerging evidence for its use in massively bleeding patients.
Transfusion-related cost comparison of trauma patients receiving whole blood versus component therapy. [2023]With the emergence of whole blood (WB) in trauma resuscitation, cost-related comparisons are of significant importance to providers, blood banks, and hospital systems throughout the country. The objective of this study was to determine if there is a transfusion-related cost difference between trauma patients who received low titer O+ whole blood (LTO+WB) and component therapy (CT).
The Use of Whole Blood Transfusion in Trauma. [2022]This review illustrates the current benefits, limitations, ongoing research, and future paths for Low Titer O Whole Blood compared to Component Therapy in massive transfusion for trauma patients.