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Hemorrhagic ShockPhase 3TOWARNCT04684719

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

A Phase 3 study testing low titer whole blood in people with Hemorrhagic Shock and Traumatic Injury, run by Jason Sperry at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Hemorrhagic Shock, Traumatic Injury
What is being tested?
low titer whole blood
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,020 participants
Where
10 sitesUnited States
Study dates
19 Apr 2022to 12 Aug 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • University of Cincinatti

    Cincinnati, Ohio, 45267

  • Metrohealth Systems

    Cleveland, Ohio, 44109

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • University of Mississippi Medical Center (UMMC)

    Jackson, Mississippi, 39216

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • University of Louisville

    Louisville, Kentucky, 40292

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • University of Washington

    Seattle, Washington, 98104

Other trials in United States

About this study

Official title: Type O Whole Blood and Assessment of Age During Prehospital Resuscitation (TOWAR) 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.

Being tested
low titer whole blood, Standard Care
Keywords
hemorrhage, trauma, whole blood
Medical subject headings
Shock, Hemorrhagic, Wounds and Injuries, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • low titer whole bloodBiological

    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 CareBiological

    crystalloid infusion or blood component transfusion resuscitation

Study groups in NCT04684719
Study groupRoleWhat they receive
Whole BloodExperimentalSubjects 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.
Receives: Biological: low titer whole blood
Standard CareActive comparatorSubjects will receive prehospital crystalloid infusion or blood component transfusion resuscitation per site standard care for the respective Emergency Medical unit/service.
Receives: Biological: Standard Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day mortality

    All cause mortality within 30 days

    Measured: Enrollment through 30 days

Secondary outcomes (20)

  1. Age of whole blood

    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

    Measured: During Procedure

  2. 3-hour mortality

    Death within 3 hours of enrollment

    Measured: Enrollment through 3 hours

  3. 6-hour mortality

    Death within 6 hours of enrollment

    Measured: Enrollment through 6 hours

  4. 24-hour mortality

    Death within 24 hours of enrollment

    Measured: Enrollment through 24 hours

  5. In-hospital mortality

    Death prior to hospital discharge

    Measured: Enrollment through hospital discharge or 30 days

  6. Time to death

    Time in days from enrollment to death

    Measured: Enrollment through death or 30 days

  7. Blood and blood component transfusion type

    Type of blood or blood component required for transfusion

    Measured: Enrollment through 24 hours

  8. Blood and blood component transfusion amount

    Number of units of blood or blood component transfused

    Measured: Enrollment through 24 hours

  9. Time to blood and blood component transfusion

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

    Measured: Enrollment time to first transfusion

  10. Multiple Organ Failure (MOF)

    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.

    Measured: Enrollment through 7 days or ICU discharge

  11. Hospital-acquired pneumonia

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

    Measured: Number of participants who develop pneumonia through 30 days

  12. blood stream infection

    Blood stream infection during hospitalization per CDC criteria

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

  13. Acute Respiratory Distress Syndrome (ARDS)

    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).

    Measured: Number of participants who develop ARDS through 30 days

  14. Prothrombin Time (PT)

    Measurement of platelet hemostatic function

    Measured: Enrollment through 60 minutes and 24 hours

  15. International Normalized Ratio (INR)

    Measurement of platelet hemostatic function

    Measured: Enrollment through 60 minutes and 24 hours

  16. Incidence of coagulopathy by rapid thrombelastography (rTEG)

    Coagulopathy as indicated by rTEG measures

    Measured: Enrollment through 60 minutes and 24 hours

  17. rTEG platelet function

    rTEG measurement of platelet hemostatic function

    Measured: Enrollment through 60 minutes and 24 hours

  18. Time to hemostasis

    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

    Measured: Enrollment through 4 hours

  19. Transfusion reaction

    Any transfusion complication

    Measured: Enrollment through 24 hours

  20. whole blood aggregometry

    platelet function test using low-dose collagen as a stimulus

    Measured: Enrollment through 60 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2020
  2. Study start19 Apr 2022
  3. Primary completion28 Jul 2025
  4. Study completion12 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,020 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04684719
Sponsor's protocol ID
STUDY20110430
Other IDs
W81XWH-16-D-0024
Acronym
TOWAR
Status last verified
Feb 2026
First submitted
18 Dec 2020
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator.

Publications

  • Sperry JL, Guyette FX, Cotton BA, Luther JF, Utarnachitt RB, Kutcher ME, Daley BJ, Peetz AB, Patel MB, Goodman MD, Claridge JA, Patel N, Harbrecht BG, Hashmi ZG, Zarychanski R, Neal MD, Yazer MH, Martin-Gill C, Vincent LE, Harner AM, Meyer DE, Latimer AJ, Robinson BR, McKnight CL, Hinckley WR, Miller KR, Jansen JO, Martin D, Fox EE, Rosario-Rivera BL, Wisniewski SR; TOWAR Study Group. Prehospital Resuscitation with Type O Whole Blood for Trauma and Hemorrhage. N Engl J Med. 2026 Jun 18;394(23):2317-2328. doi: 10.1056/NEJMoa2602167. Epub 2026 May 18.

    PubMed 42150044

  • 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.

    PubMed 40271704

  • 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.

    PubMed 38531812

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing low titer whole blood in people with Hemorrhagic Shock and Traumatic Injury, run by Jason Sperry at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day mortality (time frame: Enrollment through 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04684719, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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