Using low titer whole blood for resuscitation in trauma patients

Type O Whole Blood and Assessment of Age During Prehospital Resuscitation (TOWAR) Trial

This study is testing if using low titer whole blood to help trauma patients who are at risk of severe bleeding works better and is safer than the usual treatment they receive.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1020 (estimated)
• Ages: 18 Years to 89 Years
• Sex: All
• Sponsor: University of Pittsburgh (Academic / other)
• Locations: 10 sites (Birmingham, Alabama and 9 other locations)
• Trial ID: NCT04684719 on ClinicalTrials.gov

What this trial studies

This trial is an open-label, multi-center, pre-hospital randomized trial conducted at 10 level-1 trauma centers. It aims to evaluate the efficacy and safety of low titer whole blood resuscitation compared to standard care in patients at risk of hemorrhagic shock. The study will also assess the hemostatic competency of whole blood in relation to its age. Eligible patients include those with specific blood pressure and heart rate criteria who are being transported to participating trial sites.

Who should consider this trial

Good fit: Ideal candidates are injured patients at risk of hemorrhagic shock with specific vital sign criteria during transport.

Not a fit: Patients who are over 90 years old, under 18 years old, or have isolated injuries not related to trauma may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve survival rates and outcomes for trauma patients experiencing hemorrhagic shock.

How similar studies have performed: Other studies have shown promising results with whole blood resuscitation approaches, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1.) Injured patients at risk of hemorrhagic shock being transported from scene or referral hospital to a participating TOWAR trial site that meet requirements for initiation of blood or blood component transfusion

AND

2A.) Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital or during transport OR

2B.) Systolic blood pressure ≤ 70mmHg at scene, at outside hospital or during transport

Exclusion Criteria:

1. Wearing NO TOWAR opt-out bracelet
2. Age \> 90 or \< 18 years of age
3. Isolated fall from standing injury mechanism
4. Known prisoner or known pregnancy
5. Traumatic arrest with \> 5 minutes of CPR without return of vital signs
6. Brain matter exposed or penetrating brain injury (GSW)
7. Isolated drowning or hanging victims
8. Objection to study voiced by subject or family member at the scene
9. Inability to obtain IV or intraosseous access
10. Isolated burns without evidence of traumatic injury

Where this trial is running

Birmingham, Alabama and 9 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
• University of Louisville — Louisville, Kentucky, United States (Recruiting)
• University of Mississippi Medical Center (UMMC) — Jackson, Mississippi, United States (Recruiting)
• University of Cincinatti — Cincinnati, Ohio, United States (Recruiting)
• Metrohealth Systems — Cleveland, Ohio, United States (Recruiting)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
• University of Tennessee Medical Center — Knoxville, Tennessee, United States (Recruiting)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
• University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
• University of Washington — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Jason L Sperry, MD — University of Pittsburgh
• Study coordinator: Jason Sperry, MD

Conditions Hemorrhagic Shock; Traumatic Injury; hemorrhage; trauma; whole blood