Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial
- Conditions
- Hemorrhagic ShockTraumatic Injury
- Interventions
- Biological: low titer whole bloodBiological: Standard Care
- Registration Number
- NCT04684719
- Lead Sponsor
- Jason Sperry
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1020
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Whole Blood low titer 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. Standard Care Standard Care Subjects will receive prehospital crystalloid infusion or blood component transfusion resuscitation per site standard care for the respective Emergency Medical unit/service.
- Primary Outcome Measures
Name Time Method 30-day mortality Enrollment through 30 days All cause mortality within 30 days
- Secondary Outcome Measures
Name Time Method Blood and blood component transfusion type Enrollment through 24 hours Type of blood or blood component required for transfusion
Prothrombin Time (PT) Enrollment through 60 minutes and 24 hours Measurement of platelet hemostatic function
Age of whole blood 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
blood stream infection Number of participants who develop blood stream infection through 30 days Blood stream infection during hospitalization per CDC criteria
Acute Respiratory Distress Syndrome (ARDS) 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).
3-hour mortality Enrollment through 3 hours Death within 3 hours of enrollment
Time to death Enrollment through death or 30 days Time in days from enrollment to death
Multiple Organ Failure (MOF) 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.
Hospital-acquired pneumonia Number of participants who develop pneumonia through 30 days Pneumonia acquired during hospitalization per Center for Disease Control (CDC) criteria
Transfusion reaction Enrollment through 24 hours Any transfusion complication
6-hour mortality Enrollment through 6 hours Death within 6 hours of enrollment
In-hospital mortality Enrollment through hospital discharge or 30 days Death prior to hospital discharge
Time to blood and blood component transfusion Enrollment time to first transfusion Amount of time from enrollment to transfusion of blood or blood component
International Normalized Ratio (INR) Enrollment through 60 minutes and 24 hours Measurement of platelet hemostatic function
24-hour mortality Enrollment through 24 hours Death within 24 hours of enrollment
Blood and blood component transfusion amount Enrollment through 24 hours Number of units of blood or blood component transfused
Incidence of coagulopathy by rapid thrombelastography (rTEG) Enrollment through 60 minutes and 24 hours Coagulopathy as indicated by rTEG measures
Time to hemostasis 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
rTEG platelet function Enrollment through 60 minutes and 24 hours rTEG measurement of platelet hemostatic function
whole blood aggregometry Enrollment through 60 minutes platelet function test using low-dose collagen as a stimulus
Trial Locations
- Locations (10)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
University of Mississippi Medical Center (UMMC)
🇺🇸Jackson, Mississippi, United States
University of Cincinatti
🇺🇸Cincinnati, Ohio, United States
Metrohealth Systems
🇺🇸Cleveland, Ohio, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States