Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial
NCT ID: NCT04684719
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1020 participants
INTERVENTIONAL
2022-04-19
2025-08-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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
Standard Care
Subjects will receive prehospital crystalloid infusion or blood component transfusion resuscitation per site standard care for the respective Emergency Medical unit/service.
Standard Care
crystalloid infusion or blood component transfusion resuscitation
Interventions
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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
Standard Care
crystalloid infusion or blood component transfusion resuscitation
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
89 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Jason Sperry
OTHER
Responsible Party
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Jason Sperry
Professor
Principal Investigators
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Jason L Sperry, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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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
Countries
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References
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Brunskill SJ, Disegna A, Wong H, Fabes J, Desborough MJ, Doree C, Davenport R, Curry N, Stanworth SJ. Blood transfusion strategies for major bleeding in trauma. Cochrane Database Syst Rev. 2025 Apr 24;4(4):CD012635. doi: 10.1002/14651858.CD012635.pub2.
Meizoso JP, Cotton BA, Lawless RA, Kodadek LM, Lynde JM, Russell N, Gaspich J, Maung A, Anderson C, Reynolds JM, Haines KL, Kasotakis G, Freeman JJ. Whole blood resuscitation for injured patients requiring transfusion: A systematic review, meta-analysis, and practice management guideline from the Eastern Association for the Surgery of Trauma. J Trauma Acute Care Surg. 2024 Sep 1;97(3):460-470. doi: 10.1097/TA.0000000000004327. Epub 2024 Mar 27.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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W81XWH-16-D-0024
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY20110430
Identifier Type: -
Identifier Source: org_study_id
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