Whole Blood vs Component Transfusion for Severe Injuries

(TROOP Trial)

Recruiting at 13 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

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{2 3 5 6 7}

How 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. ^{2 4 7 8 9}

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.

Research Team

Jan Jansen, MBBS, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility 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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Cold-Stored, Low-Titer Group O Whole Blood Transfusions in Nontrauma Massive Transfusion Protocol Activations. [2023]

3. United States 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. [2023]

4. United States 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Low Titer Group O Whole Blood In Injured Children Requiring Massive Transfusion. [2023]

6. United States 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. [2021]

7. France pubmed.ncbi.nlm.nih.gov

The Dead Sea needs salt water… massively bleeding patients need whole blood: The evolution of blood product resuscitation. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Transfusion-related cost comparison of trauma patients receiving whole blood versus component therapy. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The Use of Whole Blood Transfusion in Trauma. [2022]