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

Jason Sperry

Status and phase: Enrolling; Phase 3

Conditions: Hemorrhagic Shock; Traumatic Injury

Treatments: Biological: low titer whole blood; Biological: Standard Care

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04684719

W81XWH-16-D-0024 (Other Grant/Funding Number)

STUDY20110430

Details and patient eligibility

About

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.

Enrollment: 1,020 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,020 participants in 2 patient groups

Whole Blood

Experimental group

Description:

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.

Treatment:

Biological: low titer whole blood

Standard Care

Active Comparator group

Description:

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

Treatment:

Biological: Standard Care