Clinical trial NCT04684719: Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial
Official title: Type O Whole Blood and Assessment of Age During Prehospital Resuscitation (TOWAR) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hemorrhagic Shock
Traumatic Injury
Keywords: hemorrhage
trauma
whole blood
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2020-12-24
Enrollment: 1020
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

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

Primary outcomes:
measure: 30-day mortality
timeFrame: Enrollment through 30 days
Secondary outcomes:
measure: Age of whole blood
timeFrame: During Procedure
measure: 3-hour mortality
timeFrame: Enrollment through 3 hours
measure: 6-hour mortality
timeFrame: Enrollment through 6 hours
measure: 24-hour mortality
timeFrame: Enrollment through 24 hours
measure: In-hospital mortality
timeFrame: Enrollment through hospital discharge or 30 days
measure: Time to death
timeFrame: Enrollment through death or 30 days
measure: Blood and blood component transfusion type
timeFrame: Enrollment through 24 hours
measure: Blood and blood component transfusion amount
timeFrame: Enrollment through 24 hours
measure: Time to blood and blood component transfusion
timeFrame: Enrollment time to first transfusion
measure: Multiple Organ Failure (MOF)
timeFrame: Enrollment through 7 days or ICU discharge
measure: Hospital-acquired pneumonia
timeFrame: Number of participants who develop pneumonia through 30 days
measure: blood stream infection
timeFrame: Number of participants who develop blood stream infection through 30 days
measure: Acute Respiratory Distress Syndrome (ARDS)
timeFrame: Number of participants who develop ARDS through 30 days
measure: Prothrombin Time (PT)
timeFrame: Enrollment through 60 minutes and 24 hours
measure: International Normalized Ratio (INR)
timeFrame: Enrollment through 60 minutes and 24 hours
measure: Incidence of coagulopathy by rapid thrombelastography (rTEG)
timeFrame: Enrollment through 60 minutes and 24 hours
measure: rTEG platelet function
timeFrame: Enrollment through 60 minutes and 24 hours
measure: Time to hemostasis
timeFrame: Enrollment through 4 hours
measure: Transfusion reaction
timeFrame: Enrollment through 24 hours
measure: whole blood aggregometry
timeFrame: Enrollment through 60 minutes
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Jackson
country: United States
facility: University of Mississippi Medical Center (UMMC)
state: Mississippi
city: Cincinnati
country: United States
facility: University of Cincinatti
state: Ohio
city: Cleveland
country: United States
facility: Metrohealth Systems
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Pittsburgh
name: Jason L Sperry, MD
role: PRINCIPAL_INVESTIGATOR
References: