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

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ClinicalTrials.gov Identifier: NCT04684719
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : April 27, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Jason Sperry, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Hemorrhagic Shock Traumatic Injury Biological: low titer whole blood Biological: Standard Care Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1020 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Type O Whole Blood and Assessment of Age During Prehospital Resuscitation (TOWAR) Trial
Actual Study Start Date : April 19, 2022
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
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, Rh positive 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




Primary Outcome Measures :
  1. 30-day mortality [ Time Frame: Enrollment through 30 days ]
    All cause mortality within 30 days


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04684719


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

Locations
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United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jason L Sperry, MD,MPH    412-647-3065    sperryjl@upmd.edu   
Principal Investigator: Jason L Sperry, MD,MPH         
Sponsors and Collaborators
Jason Sperry
United States Department of Defense
Investigators
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Principal Investigator: Jason L Sperry, MD University of Pittsburgh
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Responsible Party: Jason Sperry, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04684719    
Other Study ID Numbers: STUDY20110430
W81XWH-16-D-0024 ( Other Grant/Funding Number: Department of Defense )
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator.
Supporting Materials: Study Protocol
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jason Sperry, University of Pittsburgh:
hemorrhage
trauma
whole blood
Additional relevant MeSH terms:
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Shock, Hemorrhagic
Wounds and Injuries
Hemorrhage
Pathologic Processes
Shock