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

NCT04684719 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: STUDY20110430W81XWH-16-D-0024
• Study Type: interventional
• Target: 1,020
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Hemorrhagic Shock; Traumatic Injury

Keywords

hemorrhage; trauma; whole blood

Outcome Measures

Primary Outcomes (1)

• 30-day mortality

  All cause mortality within 30 days

  Enrollment through 30 days

Secondary Outcomes (20)

• Age of whole blood

  During Procedure

• 3-hour mortality

  Enrollment through 3 hours

• 6-hour mortality

  Enrollment through 6 hours

• 24-hour mortality

  Enrollment through 24 hours

• In-hospital mortality

  Enrollment through hospital discharge or 30 days

Study Arms (2)

Whole Blood

EXPERIMENTAL

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

Standard Care

ACTIVE COMPARATOR

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

Interventions

low titer whole blood BIOLOGICAL

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

Whole Blood

Standard Care BIOLOGICAL

crystalloid infusion or blood component transfusion resuscitation

Standard Care

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ) 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
• A.) Systolic blood pressure ≤ 90mmHg and tachycardia (HR ≥ 108) at scene, at outside hospital or during transport OR
• B.) Systolic blood pressure ≤ 70mmHg at scene, at outside hospital or during transport

You may not qualify if:

• 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
• Inability to obtain IV or intraosseous access
• Isolated burns without evidence of traumatic injury

Sponsors & Collaborators

• Jason Sperry: lead
• United States Department of Defense: collaborator

Study Sites (10)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Louisville

Louisville, Kentucky, 40292, United States

Location

University of Mississippi Medical Center (UMMC)

Jackson, Mississippi, 39216, United States

Location

University of Cincinatti

Cincinnati, Ohio, 45267, United States

Location

Metrohealth Systems

Cleveland, Ohio, 44109, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (2)

• 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.

  PMID: 40271704 DERIVED

• 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.

  PMID: 38531812 DERIVED

MeSH Terms

Conditions

Shock, Hemorrhagic; Wounds and Injuries; Hemorrhage

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jason L Sperry, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 24, 2020
• Study Start: April 19, 2022
• Primary Completion: July 28, 2025
• Study Completion: August 12, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available after publication of the primary manuscript.
• Access Criteria: Requests for data will be submitted in writing and reviewed by the Principal Investigator.

Locations

US (10)