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NCT Number: NCT04684719

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

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.

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Key information

Conditions

Hemorrhagic Shock Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Hemorrhagic Traumatic Injury Wounds and Injuries

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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

Standard Care

Biological

crystalloid infusion or blood component transfusion resuscitation

Primary outcomes

  1. 30-day mortality

    Time frame: Enrollment through 30 days

    All cause mortality within 30 days

Secondary outcomes

  1. Age of whole blood

    Time frame: During Procedure

    Age of units of whole blood in days categorized into young (1-14 days) and old (>14 days) and compared across primary and secondary outcomes

  2. 3-hour mortality

    Time frame: Enrollment through 3 hours

    Death within 3 hours of enrollment

  3. 6-hour mortality

    Time frame: Enrollment through 6 hours

    Death within 6 hours of enrollment

  4. 24-hour mortality

    Time frame: Enrollment through 24 hours

    Death within 24 hours of enrollment

  5. In-hospital mortality

    Time frame: Enrollment through hospital discharge or 30 days

    Death prior to hospital discharge

  6. Time to death

    Time frame: Enrollment through death or 30 days

    Time in days from enrollment to death

  7. Blood and blood component transfusion type

    Time frame: Enrollment through 24 hours

    Type of blood or blood component required for transfusion

  8. Blood and blood component transfusion amount

    Time frame: Enrollment through 24 hours

    Number of units of blood or blood component transfused

  9. Time to blood and blood component transfusion

    Time frame: Enrollment time to first transfusion

    Amount of time from enrollment to transfusion of blood or blood component

  10. Multiple Organ Failure (MOF)

    Time frame: Enrollment through 7 days or ICU discharge

    Organ dysfunction will be evaluated via the Denver Post-injury Multiple Organ Failure Score. Patients who are never admitted to the Intensive Care Unit (ICU) or those with a length of ICU stay of less than 48 hours will be considered to have a Denver score of 0. A summary of the Denver score may be calculated by summing the worst scores of each of the individual systems over the course of the ICU stay. A summary Denver score > 3 will be classified as MOF.

  11. Hospital-acquired pneumonia

    Time frame: Number of participants who develop pneumonia through 30 days

    Pneumonia acquired during hospitalization per Center for Disease Control (CDC) criteria

  12. blood stream infection

    Time frame: Number of participants who develop blood stream infection through 30 days

    Blood stream infection during hospitalization per CDC criteria

  13. Acute Respiratory Distress Syndrome (ARDS)

    Time frame: Number of participants who develop ARDS through 30 days

    The Berlin definition for mild ARDS (PaO2/FIO2, ≤ 300 mm Hg + timing, imaging and origin criteria) will be utilized as a threshold value to determine the incidence of ARDS and will be further stratified into Moderate (PaO2/FIO2, ≤ 200 mm Hg) and Severe (PaO2/FIO2, ≤ 100 mm Hg).

  14. Prothrombin Time (PT)

    Time frame: Enrollment through 60 minutes and 24 hours

    Measurement of platelet hemostatic function

  15. International Normalized Ratio (INR)

    Time frame: Enrollment through 60 minutes and 24 hours

    Measurement of platelet hemostatic function

  16. Incidence of coagulopathy by rapid thrombelastography (rTEG)

    Time frame: Enrollment through 60 minutes and 24 hours

    Coagulopathy as indicated by rTEG measures

  17. rTEG platelet function

    Time frame: Enrollment through 60 minutes and 24 hours

    rTEG measurement of platelet hemostatic function

  18. Time to hemostasis

    Time frame: Enrollment through 4 hours

    Ability to reach nadir transfusion requirement of 1 unit of red blood cells in a 60-minute time period in the first 4 hours following arrival

  19. Transfusion reaction

    Time frame: Enrollment through 24 hours

    Any transfusion complication

  20. whole blood aggregometry

    Time frame: Enrollment through 60 minutes

    platelet function test using low-dose collagen as a stimulus

Sponsors and collaborators

Lead sponsor

Jason Sperry

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Acronym: TOWAR

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 24, 2020
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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