Whole Blood vs Component Transfusion for Severe Injuries

(TROOP Trial)

Recruiting at 14 trial locations

Overseen By Kiran Mansoor, MBBS

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Alabama at Birmingham

Disqualifiers: Prisoners, Moribund, DNR orders, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 30 days

1100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether whole blood or separate blood components, such as red cells and plasma, work better for people with severe injuries. Participants will be divided into two groups, receiving either whole blood or the separate components. The trial targets trauma patients who require significant blood transfusions due to major bleeding. Those who have begun a blood transfusion and are transported directly to a trauma center from the accident scene may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Low-Titer Group O Whole Blood (LTOWB) is generally safe for trauma patients. Studies indicate it has similar rates of transfusion reactions as traditional blood products and helps reduce complications after emergency room care.

Recent studies highlight the effectiveness of individual blood components like red cells, plasma, platelets, and cryoprecipitate, especially when used early in trauma treatment. However, some evidence suggests a higher risk of short-term death with these components compared to whole blood.

Both whole blood and separate components have been used for a long time, and their safety is well-documented. Patients generally tolerate them well. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it compares two different ways of giving blood to people with severe injuries. The standard approach involves giving separate blood components, like red blood cells, plasma, and platelets, to address the specific needs of the patient. However, one of the trial's treatments uses Low-Titer Group O Whole Blood (LTOWB), which contains all these components in one package. The LTOWB method could potentially simplify and speed up transfusions, providing a more efficient way to stabilize patients quickly in critical situations. Understanding which method works best could improve survival rates and outcomes for severely injured patients.

What evidence suggests that this trial's treatments could be effective for severe injuries?

In this trial, participants will be randomized to receive either Low-Titer Group O Whole Blood (LTOWB) or component blood products. Research has shown that LTOWB can significantly aid patients with serious injuries, potentially increasing survival chances in the first 24 hours and simplifying the transfusion process. Conversely, using separate blood parts like red cells and plasma, known as blood component therapy, is also effective. Some studies have found that administering these components earlier and in larger amounts can lead to better outcomes. However, recent research suggests that whole blood might be more beneficial in treating trauma cases. ^{1 2 3 4 6}

Who Is on the Research Team?

Jan Jansen, MBBS, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Patients transferred from another hospital

Individuals with a research 'opt out' bracelet

I needed emergency chest surgery or had CPR for more than 5 minutes before getting blood products.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Components
• Low-Titer Group O Whole Blood

Trial Overview 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.

How Is the Trial Designed?

Group I: LTOWB Active Control 1 Intervention

Participants randomized to receive (Low Titer O Whole Blood \[LTOWB\])

Group II: Components Active Control 1 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

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Published Research Related to This Trial

Low anti-A and -B titer group O whole blood (LTOWB) is being reconsidered for use in massively bleeding trauma patients due to its advantages over conventional blood component therapy, such as simplified logistics and better concentration of blood components.

Retrospective data suggests that patients receiving LTOWB do not have worse outcomes compared to those receiving conventional components, and in some cases, they may experience more favorable outcomes, although randomized controlled trials are still ongoing to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dead Sea needs salt water… massively bleeding patients need whole blood: The evolution of blood product resuscitation. Seheult, JN., Bahr, MP., Spinella, PC., et al.[2020]

A survey of 36 US children's hospitals revealed strong support among transfusion medicine and trauma directors for conducting a randomized control trial (RCT) comparing low-titer group O whole-blood (LTOWB) to standard blood component transfusion in children with life-threatening traumatic bleeding, with 86.7% of TM directors and 90.6% of trauma directors agreeing on its importance.

Currently, only 18.8% of trauma directors reported using LTOWB, but a significant majority (83.3% of TM directors and 93.8% of trauma directors) expressed willingness to participate in the proposed trial, indicating a readiness to explore LTOWB as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey to inform trial of low-titer group O whole-blood compared to conventional blood components for children with severe traumatic bleeding. Kolodziej, JH., Leonard, JC., Josephson, CD., et al.[2021]

A study comparing 155 trauma patients receiving low-titer group O whole blood (LTOWB) to 165 patients receiving conventional component therapy (CCT) found no significant differences in mortality rates or major clinical outcomes within the first 30 days after treatment.

The LTOWB group showed a lower delta MODS (Multiple Organ Dysfunction Score), suggesting potential benefits in organ function despite similar overall outcomes compared to CCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Yazer, MH., Freeman, A., Harrold, IM., et al.[2021]

In a study of 80 injured pediatric patients requiring massive transfusion, those who received low-titer group O whole blood (LTOWB) showed significantly improved survival rates at both 72 hours and 28 days post-injury compared to those receiving conventional blood components.

Patients receiving LTOWB also experienced shorter hospital stays, fewer days in the ICU, and reduced ventilator use, indicating not only better survival but also improved recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Titer Group O Whole Blood In Injured Children Requiring Massive Transfusion. Gaines, BA., Yazer, MH., Triulzi, DJ., et al.[2023]

In a study comparing 36 pediatric patients receiving low titer group O whole blood (LTOWB) to 36 receiving conventional red blood cell components, there were no significant differences in adverse events such as transfusion reactions, organ failure, or acute kidney injury.

The LTOWB group experienced a significantly shorter ICU length of stay compared to the component group, suggesting that LTOWB may be a safe and effective initial resuscitative fluid in pediatric trauma without increasing adverse outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events after low titer group O whole blood versus component product transfusion in pediatric trauma patients: A propensity-matched cohort study. Leeper, CM., Yazer, MH., Morgan, KM., et al.[2021]

In a study involving 103 nontrauma patients requiring massive transfusions, the use of low-titer group O whole blood (LTOWB) showed no significant difference in 24-hour or 30-day mortality compared to standard blood component therapy.

Patients receiving LTOWB had a statistically significant shorter hospital stay, averaging 1.58 days less than those receiving component therapy, indicating potential logistical benefits of using LTOWB in nontrauma settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Cold-Stored, Low-Titer Group O Whole Blood Transfusions in Nontrauma Massive Transfusion Protocol Activations. Christian, RJ., McDavitt, C., Nguyen, T., et al.[2023]

Low Titer O Whole Blood transfusions have been shown to improve patient outcomes and simplify transfusion logistics compared to traditional Component Therapy in trauma patients, based on recent studies.

Despite challenges related to cost and supply, military experience suggests these issues can be managed, leading to an increased use of Whole Blood in civilian trauma care, with ongoing research focusing on specific populations like women of child-bearing age and children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Whole Blood Transfusion in Trauma. Hanna, M., Knittel, J., Gillihan, J.[2022]

The use of low titer O+ whole blood (LTO+WB) in trauma resuscitation significantly reduced costs, with an average savings of over $927,000 compared to component therapy (CT) after its implementation in January 2018.

In adult trauma patients, LTO+WB resulted in lower costs per patient and per milliliter at multiple time points (4 hours, 24 hours, and overall), particularly benefiting severely injured patients with an Injury Severity Score greater than 15.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transfusion-related cost comparison of trauma patients receiving whole blood versus component therapy. Ciaraglia, A., Myers, JC., Braverman, M., et al.[2023]

In a study of 164 pediatric trauma patients, the use of non-leukoreduced low-titer group O whole blood (LTOWB) with anti-A/anti-B antibody titers of <1:200 was found to be safe, showing no significant differences in hemolysis markers compared to those receiving only red blood cells and plasma.

While there was no initial difference in survival rates, adjusted analyses suggested that LTOWB administration may be associated with improved survival, indicating a potential mortality benefit despite the higher severity of injuries in those receiving LTOWB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An assessment of the safety, hemostatic efficacy, and clinical impact of low-titer group O whole blood in children and adolescents. Gerard, J., Mueck, K., Lubkin, D., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8761832/

The Use of Whole Blood Transfusion in Trauma - PMC Many studies show that compared to Component Therapy, Low Titer O Whole Blood transfusion is associated with better patient outcomes and simplified transfusion ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3126660/

Optimal Use of Blood Products in Severely Injured Trauma ... Numerous recent retrospective single and multicenter studies have associated improved outcomes with earlier and increased use of plasma and platelets. These ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0049384825002452

Evaluating the safety outcomes of whole blood versus ... Emerging evidence suggests that whole blood may offer improved mortality outcomes compared to component therapy [10]. Furthermore, due to its lower overall ...

4. facs.org facs.org/for-medical-professionals/news-publications/news-and-articles/bulletin/2023/april-2023-volume-108-issue-4/whole-blood-in-resuscitating-trauma-patients-is-making-a-comeback/

Whole Blood in Resuscitating Trauma Patients Is Making a ... Emerging research reveals whole blood is a better option than fractionated components of blood for trauma patients.

5. journalofsurgicalresearch.com journalofsurgicalresearch.com/article/S0022-4804(23)00056-2/fulltext

Outcomes of Transfusion With Whole Blood, Component ... This study identified an increased risk of 24-h mortality with COMP versus WB + COMP (relative risk: 1.40 [1.10, 1.78]) and increased ...

6. journals.lww.com journals.lww.com/annalsofsurgery/fulltext/2024/12000/whole_blood_and_blood_component_resuscitation_in.20.aspx

Whole Blood and Blood Component Resuscitation in ... Outcomes. The primary outcome of this study was 4-hour mortality. Recent trauma resuscitation literature suggests that ∼85% of hemorrhage-related deaths after ...