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Search / Trial NCT04684719

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

Launched by JASON SPERRY · Dec 23, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Hemorrhage Trauma Whole Blood

ClinConnect Summary

The Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial is studying how effective and safe it is to use low titer whole blood for treating patients who are at risk of hemorrhagic shock due to traumatic injuries. This trial is taking place in 10 trauma centers and aims to compare this method with the standard treatment currently used. Researchers want to find out how well whole blood works depending on its age, which means they are looking at how fresh or old the blood is when it's used.

To participate in this trial, patients must be between the ages of 18 and 90 and have suffered injuries that put them at risk of hemorrhagic shock. For example, eligible patients might have low blood pressure or a fast heartbeat when they are being transported to the hospital. If someone is accepted into the study, they will either receive the low titer whole blood or the standard treatment while being transported. It's important to know that there are specific reasons someone might not be able to join the trial, such as if they have certain types of injuries or if they are a prisoner or pregnant. Overall, this trial hopes to improve emergency care for those with serious injuries.

Gender

ALL

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

About Jason Sperry

Jason Sperry, MD, is a prominent clinical trial sponsor known for his commitment to advancing medical research and improving patient outcomes. With extensive experience in clinical trials, particularly in trauma and emergency medicine, Dr. Sperry leads innovative studies that focus on developing novel therapies and treatment protocols. His dedication to evidence-based practices and collaboration with multidisciplinary teams underscores his role in enhancing the quality and efficacy of healthcare interventions. Dr. Sperry's contributions to the field are characterized by a rigorous approach to trial design and a steadfast commitment to ethical standards in patient care and research.

Locations

Pittsburgh, Pennsylvania, United States

Birmingham, Alabama, United States

Houston, Texas, United States

Nashville, Tennessee, United States

Knoxville, Tennessee, United States

Louisville, Kentucky, United States

Seattle, Washington, United States

Cleveland, Ohio, United States

Cincinnati, Ohio, United States

Jackson, Mississippi, United States

Seattle, Washington, United States

Patients applied

0 patients applied

Trial Officials

Jason L Sperry, MD

Principal Investigator

University of Pittsburgh

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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