Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial
Purpose
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.
Conditions
- Hemorrhagic Shock
- Traumatic Injury
Eligibility
- Eligible Ages
- Between 18 Years and 89 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 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
- 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Whole Blood |
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. |
|
|
Active Comparator Standard Care |
Subjects will receive prehospital crystalloid infusion or blood component transfusion resuscitation per site standard care for the respective Emergency Medical unit/service. |
|
Recruiting Locations
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- Jason Sperry