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

Completed · Phase 3

Conditions studied: Hemorrhagic Shock, Traumatic Injury

In brief

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.

Key facts

Study ID

NCT04684719

Run by

Jason Sperry

People needed

1020

Starts

2022-04-19

Expected to finish

2025-08-12

Last updated by the study team

2026-02-12

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ) 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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.