Back to resultsType O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial (TOWAR)
Primary Purpose
Hemorrhagic Shock, Traumatic Injury
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
low titer whole blood
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhagic Shock focused on measuring hemorrhage, trauma, whole blood
Eligibility 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:
- 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
Sites / Locations
- University of Mississippi Medical Center (UMMC)Recruiting
- University of CincinattiRecruiting
- Metrohealth SystemsRecruiting
- University of PittsburghRecruiting
- University of Tennessee Medical CenterRecruiting
- Vanderbilt University Medical CenterRecruiting
- University of Texas Health Science Center at HoustonRecruiting
- University of WashingtonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Whole Blood
Standard Care
Arm Description
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.
Subjects will receive prehospital crystalloid infusion or blood component transfusion resuscitation per site standard care for the respective Emergency Medical unit/service.
Outcomes
Primary Outcome Measures
30-day mortality
All cause mortality within 30 days
Secondary Outcome Measures
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
3-hour mortality
Death within 3 hours of enrollment
6-hour mortality
Death within 6 hours of enrollment
24-hour mortality
Death within 24 hours of enrollment
In-hospital mortality
Death prior to hospital discharge
Time to death
Time in days from enrollment to death
Blood and blood component transfusion type
Type of blood or blood component required for transfusion
Blood and blood component transfusion amount
Number of units of blood or blood component transfused
Time to blood and blood component transfusion
Amount of time from enrollment to transfusion of blood or blood component
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.
Hospital-acquired pneumonia
Pneumonia acquired during hospitalization per Center for Disease Control (CDC) criteria
blood stream infection
Blood stream infection during hospitalization per CDC criteria
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).
Prothrombin Time (PT)
Measurement of platelet hemostatic function
International Normalized Ratio (INR)
Measurement of platelet hemostatic function
Incidence of coagulopathy by rapid thrombelastography (rTEG)
Coagulopathy as indicated by rTEG measures
rTEG platelet function
rTEG measurement of platelet hemostatic function
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
Transfusion reaction
Any transfusion complication
whole blood aggregometry
platelet function test using low-dose collagen as a stimulus
Full Information
NCT ID
NCT04684719
First Posted
December 18, 2020
Last Updated
September 23, 2023
Sponsor
Jason Sperry
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT04684719
Brief Title
Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial
Acronym
TOWAR
Official Title
Type O Whole Blood and Assessment of Age During Prehospital Resuscitation (TOWAR) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2022 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jason Sperry
Collaborators
United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Shock, Traumatic Injury
Keywords
hemorrhage, trauma, whole blood
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1020 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Whole Blood
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Subjects will receive prehospital crystalloid infusion or blood component transfusion resuscitation per site standard care for the respective Emergency Medical unit/service.
Intervention Type
Biological
Intervention Name(s)
low titer whole blood
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Standard Care
Intervention Description
crystalloid infusion or blood component transfusion resuscitation
Primary Outcome Measure Information:
Title
30-day mortality
Description
All cause mortality within 30 days
Time Frame
Enrollment through 30 days
Secondary Outcome Measure Information:
Title
Age of whole blood
Description
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
Time Frame
During Procedure
Title
3-hour mortality
Description
Death within 3 hours of enrollment
Time Frame
Enrollment through 3 hours
Title
6-hour mortality
Description
Death within 6 hours of enrollment
Time Frame
Enrollment through 6 hours
Title
24-hour mortality
Description
Death within 24 hours of enrollment
Time Frame
Enrollment through 24 hours
Title
In-hospital mortality
Description
Death prior to hospital discharge
Time Frame
Enrollment through hospital discharge or 30 days
Title
Time to death
Description
Time in days from enrollment to death
Time Frame
Enrollment through death or 30 days
Title
Blood and blood component transfusion type
Description
Type of blood or blood component required for transfusion
Time Frame
Enrollment through 24 hours
Title
Blood and blood component transfusion amount
Description
Number of units of blood or blood component transfused
Time Frame
Enrollment through 24 hours
Title
Time to blood and blood component transfusion
Description
Amount of time from enrollment to transfusion of blood or blood component
Time Frame
Enrollment time to first transfusion
Title
Multiple Organ Failure (MOF)
Description
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.
Time Frame
Enrollment through 7 days or ICU discharge
Title
Hospital-acquired pneumonia
Description
Pneumonia acquired during hospitalization per Center for Disease Control (CDC) criteria
Time Frame
Number of participants who develop pneumonia through 30 days
Title
blood stream infection
Description
Blood stream infection during hospitalization per CDC criteria
Time Frame
Number of participants who develop blood stream infection through 30 days
Title
Acute Respiratory Distress Syndrome (ARDS)
Description
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).
Time Frame
Number of participants who develop ARDS through 30 days
Title
Prothrombin Time (PT)
Description
Measurement of platelet hemostatic function
Time Frame
Enrollment through 60 minutes and 24 hours
Title
International Normalized Ratio (INR)
Description
Measurement of platelet hemostatic function
Time Frame
Enrollment through 60 minutes and 24 hours
Title
Incidence of coagulopathy by rapid thrombelastography (rTEG)
Description
Coagulopathy as indicated by rTEG measures
Time Frame
Enrollment through 60 minutes and 24 hours
Title
rTEG platelet function
Description
rTEG measurement of platelet hemostatic function
Time Frame
Enrollment through 60 minutes and 24 hours
Title
Time to hemostasis
Description
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
Time Frame
Enrollment through 4 hours
Title
Transfusion reaction
Description
Any transfusion complication
Time Frame
Enrollment through 24 hours
Title
whole blood aggregometry
Description
platelet function test using low-dose collagen as a stimulus
Time Frame
Enrollment through 60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Sperry, MD
Phone
412-802-8270
Email
sperryjl@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason L Sperry, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Medical Center (UMMC)
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Kutcher, MD
Phone
601-815-1312
Email
mkutcher@umc.edu
Facility Name
University of Cincinatti
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Goodman, MD
Phone
513-558-5661
Email
goodmamd@ucmail.uc.edu
Facility Name
Metrohealth Systems
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Claridge
Phone
216-778-4684
Email
jclaridge@metrohealth.org
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason L Sperry, MD,MPH
Phone
412-647-3065
Email
sperryjl@upmd.edu
First Name & Middle Initial & Last Name & Degree
Jason L Sperry, MD,MPH
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Daley, MD
Phone
865-251-4685
Email
bdaley@utmck.edu
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mayur Patel, MD
Phone
615-936-0083
Email
mayur.b.patel@vumc.org
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bryan Cotton
Phone
713-500-7313
Email
Bryan.A.Cotton@uth.tmc.edu
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Utarnachitt, MD, MS
Phone
206-744-8468
Email
rutarnac@uw.edu
First Name & Middle Initial & Last Name & Degree
Richard Utarnachitt, MD, MS
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator.
IPD Sharing Time Frame
Data will become available after publication of the primary manuscript.
IPD Sharing Access Criteria
Requests for data will be submitted in writing and reviewed by the Principal Investigator.
Learn more about this trial
Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial
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