Low Titer Whole Blood for Hemorrhagic Shock

(TOWAR Trial)

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen by Jason Sperry, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Jason Sperry

Disqualifiers: Age > 90, < 18, Pregnancy, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma centers designed to determine the efficacy and safety of low titer whole blood resuscitation as compared to standard of care resuscitation in patients at risk of hemorrhagic shock and to appropriately characterize the hemostatic competency of whole blood relative to its age.

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of the treatment Low Titer Whole Blood for Hemorrhagic Shock?

Research shows that using low-titer group O whole blood (LTOWB) for treating severe bleeding improves survival rates compared to other blood component therapies. Studies also indicate that LTOWB reduces early death in patients with hemorrhagic shock when used before reaching the hospital.

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Is low titer whole blood safe for humans?

Research shows that low titer group O whole blood (LTOWB) is generally safe for use in both adults and children, with studies indicating improved survival rates and fewer blood transfusions needed in trauma patients. While there is limited data on adverse events, its use in pediatric trauma has been shown to be safe when specific precautions are taken.

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How is Low Titer Whole Blood treatment different for hemorrhagic shock?

Low Titer Whole Blood (LTOWB) is unique because it combines all blood components in one transfusion, providing a balanced resuscitation that can improve survival rates compared to traditional component therapy, which separates blood into parts like red cells and plasma. This approach is especially beneficial in emergency settings, as it simplifies the transfusion process and reduces the need for multiple transfusions.

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Eligibility Criteria

This trial is for people with severe injuries at risk of hemorrhagic shock who have very low blood pressure. It's open to adults aged 18-90, not including pregnant individuals, prisoners, or those with specific types of brain injuries and other exclusions like drowning or hanging victims without other trauma.

Inclusion Criteria

Systolic blood pressure ≤ 70mmHg at scene, at outside hospital or during transport

I am at risk of severe bleeding and being taken to a hospital for a blood transfusion.

My blood pressure was 90 or lower and my heart rate was 108 or higher.

Exclusion Criteria

Wearing NO TOWAR opt-out bracelet

Doctors cannot use veins or bones for my treatments.

You have only fallen from a standing position and not experienced any other injury mechanism.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Prehospital Resuscitation

Participants receive either whole blood or standard care resuscitation in the prehospital phase

Immediate

1 visit (in-person)

In-hospital Monitoring

Participants are monitored for various outcomes including mortality, infections, and organ failure

Up to 30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study compares the effectiveness and safety of using low titer whole blood versus standard care in pre-hospital settings for patients at risk of bleeding out. It involves multiple trauma centers and looks at how well the donated blood works based on its age.

Group I: Whole Blood Experimental Treatment 1 Intervention

Subjects will receive up to two units of whole blood as collected by local blood bank procedures and stored at 1-6 degrees Celsius initiated in the prehospital phase of care.

Group II: Standard Care Active Control 1 Intervention

Subjects will receive prehospital crystalloid infusion or blood component transfusion resuscitation per site standard care for the respective Emergency Medical unit/service.

Low Titer Whole Blood is already approved in United States for the following indications:

🇺🇸 Approved in United States as Low Titer Group O Whole Blood for:

• Hemorrhagic shock
• Trauma resuscitation

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Washinton Seattle, WA

University of Tennessee Medical Center Knoxville, TN

University of Cincinatti Cincinnati, OH

University of Texas Health Science Center at Houston Houston, TX

More Trial Locations

Who Is Running the Clinical Trial?

Jason Sperry Lead Sponsor

United States Department of Defense Collaborator

References

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

Emergency transfusion with whole blood versus packed red blood cells: A study of 1400 patients. [2023] Low-titer group O whole blood (LTOWB) is increasingly used for emergency transfusion. We studied whether initial release of LTOWB compared with packed red blood cells (pRBCs) reduced overall blood requirements for patients needing emergency transfusion. Secondary outcomes examined included survival and non-lethal adverse clinical outcomes.

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

The use of low-titer group O whole blood is independently associated with improved survival compared to component therapy in adults with severe traumatic hemorrhage. [2021] There is a resurgence in the use of low-titer group O whole blood (LTOWB) for hemorrhagic shock. We hypothesized the use of LTOWB compared to component therapy (CT) would be independently associated with improved 24-hour mortality.

3. 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] 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.

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

A comparison between leukocyte reduced low titer whole blood vs non-leukocyte reduced low titer whole blood for massive transfusion activation. [2021] Hemorrhagic shock is the leading cause of survivable death in trauma patients and recent literature has focused on resuscitation strategies including transfusing low-titer group O whole blood (LTOWB). Debate remains regarding whether leukocyte reduced (LR) whole blood is of clinical benefit or detriment to patients requiring massive transfusion. This study compares survival outcomes between LR-LTOWB and non-LR LTOWB.

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

Prehospital whole blood reduces early mortality in patients with hemorrhagic shock. [2021] Low titer O+ whole blood (LTOWB) is being increasingly used for resuscitation of hemorrhagic shock in military and civilian settings. The objective of this study was to identify the impact of prehospital LTOWB on survival for patients in shock receiving prehospital LTOWB transfusion.

6. 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] 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

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

Cold-stored whole blood and platelet counts in severe acute injury: A comparison of four retrospective cohorts. [2022] Low-titer group O whole blood (LTOWB) is attractive for acute trauma care as it delivers concentrated and balanced hemostatic resuscitation in single large bags. Whether cold-stored LTOWB can sustain platelet counts is unclear.

8. England pubmed.ncbi.nlm.nih.gov

Doing more with less: low-titer group O whole blood resulted in less total transfusions and an independent association with survival in adults with severe traumatic hemorrhage. [2023] Low-titer group O whole blood (LTOWB) or component therapy (CT) may be used to resuscitate hemorrhaging trauma patients. LTOWB may have clinical and logistical benefits and may improve survival.