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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

Eligibility

Eligible Ages
Between 18 Years and 89 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned 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.
  • Biological: low titer whole blood
    low titer whole blood, group O kept to either 21 days or 35 days based upon which preservation process is employed at each respective participating site
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.
  • Biological: Standard Care
    crystalloid infusion or blood component transfusion resuscitation

Recruiting Locations

Metrohealth Systems
Cleveland, Ohio 44109
Contact:
Jeffrey Claridge
2167784684
jclaridge@metrohealth.org

More Details

Status
Recruiting
Sponsor
Jason Sperry

Study Contact

Jason Sperry, MD
412-802-8270
sperryjl@upmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.