CompletedPhase 3

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

United States1,020 participantsStarted 2022-04-19

Plain-language summary

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.

Who can participate

Age range18 Years – 89 Years

SexALL

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Inclusion criteria

✓.) 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

Exclusion criteria

✕. 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

What they're measuring

30-day mortality

Timeframe: Enrollment through 30 days

Trial details

NCT IDNCT04684719

SponsorJason Sperry

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-28

View on ClinicalTrials.gov More Hemorrhagic Shock trials