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

Hemorrhagic Shock Clinical Trial

— TOWAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04684719
• Other study ID #: STUDY20110430
• Secondary ID: W81XWH-16-D-0024
• Status: Recruiting
• Phase: Phase 3
• Start date: April 19, 2022
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: University of Pittsburgh
• Contact: Jason Sperry, MD
• Phone: 412-802-8270
• Email: sperryjl[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 competency of whole blood relative to its age.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1020
• Est. completion date: September 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

10. Isolated burns without evidence of traumatic injury

Related Conditions & MeSH terms

• Hemorrhagic Shock
• Shock, Hemorrhagic
• Traumatic Injury
• Wounds and Injuries

Intervention

Biological:
• low titer whole blood
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
crystalloid infusion or blood component transfusion resuscitation

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Cincinatti	Cincinnati	Ohio
United States	Metrohealth Systems	Cleveland	Ohio
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	University of Mississippi Medical Center (UMMC)	Jackson	Mississippi
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	University of Louisville	Louisville	Kentucky
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Jason Sperry	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality	All cause mortality within 30 days	Enrollment through 30 days
Secondary	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	During Procedure
Secondary	3-hour mortality	Death within 3 hours of enrollment	Enrollment through 3 hours
Secondary	6-hour mortality	Death within 6 hours of enrollment	Enrollment through 6 hours
Secondary	24-hour mortality	Death within 24 hours of enrollment	Enrollment through 24 hours
Secondary	In-hospital mortality	Death prior to hospital discharge	Enrollment through hospital discharge or 30 days
Secondary	Time to death	Time in days from enrollment to death	Enrollment through death or 30 days
Secondary	Blood and blood component transfusion type	Type of blood or blood component required for transfusion	Enrollment through 24 hours
Secondary	Blood and blood component transfusion amount	Number of units of blood or blood component transfused	Enrollment through 24 hours
Secondary	Time to blood and blood component transfusion	Amount of time from enrollment to transfusion of blood or blood component	Enrollment time to first transfusion
Secondary	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.	Enrollment through 7 days or ICU discharge
Secondary	Hospital-acquired pneumonia	Pneumonia acquired during hospitalization per Center for Disease Control (CDC) criteria	Number of participants who develop pneumonia through 30 days
Secondary	blood stream infection	Blood stream infection during hospitalization per CDC criteria	Number of participants who develop blood stream infection through 30 days
Secondary	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).	Number of participants who develop ARDS through 30 days
Secondary	Prothrombin Time (PT)	Measurement of platelet hemostatic function	Enrollment through 60 minutes and 24 hours
Secondary	International Normalized Ratio (INR)	Measurement of platelet hemostatic function	Enrollment through 60 minutes and 24 hours
Secondary	Incidence of coagulopathy by rapid thrombelastography (rTEG)	Coagulopathy as indicated by rTEG measures	Enrollment through 60 minutes and 24 hours
Secondary	rTEG platelet function	rTEG measurement of platelet hemostatic function	Enrollment through 60 minutes and 24 hours
Secondary	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	Enrollment through 4 hours
Secondary	Transfusion reaction	Any transfusion complication	Enrollment through 24 hours
Secondary	whole blood aggregometry	platelet function test using low-dose collagen as a stimulus	Enrollment through 60 minutes