Hemorrhagic Shock, Traumatic Injury
Conditions
Keywords
hemorrhage, trauma, whole blood
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.
Interventions
BIOLOGICALlow 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
BIOLOGICALStandard Care
crystalloid infusion or blood component transfusion resuscitation
Sponsors
Jason Sperry
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day mortality | Enrollment through 30 days | All cause mortality within 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 3-hour mortality | Enrollment through 3 hours | Death within 3 hours of enrollment |
| 6-hour mortality | Enrollment through 6 hours | Death within 6 hours of enrollment |
| 24-hour mortality | Enrollment through 24 hours | Death within 24 hours of enrollment |
| In-hospital mortality | Enrollment through hospital discharge or 30 days | Death prior to hospital discharge |
| Time to death | Enrollment through death or 30 days | Time in days from enrollment to death |
| Blood and blood component transfusion type | Enrollment through 24 hours | Type of blood or blood component required for transfusion |
| Blood and blood component transfusion amount | Enrollment through 24 hours | Number of units of blood or blood component transfused |
| Time to blood and blood component transfusion | Enrollment time to first transfusion | Amount of time from enrollment to transfusion of blood or blood component |
| 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 |
| 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). |
| Prothrombin Time (PT) | Enrollment through 60 minutes and 24 hours | Measurement of platelet hemostatic function |
| International Normalized Ratio (INR) | Enrollment through 60 minutes and 24 hours | Measurement of platelet hemostatic function |
| Incidence of coagulopathy by rapid thrombelastography (rTEG) | Enrollment through 60 minutes and 24 hours | Coagulopathy as indicated by rTEG measures |
| rTEG platelet function | Enrollment through 60 minutes and 24 hours | rTEG measurement of platelet hemostatic function |
| Transfusion reaction | Enrollment through 24 hours | Any transfusion complication |
| 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 |
| whole blood aggregometry | Enrollment through 60 minutes | platelet function test using low-dose collagen as a stimulus |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJason L Sperry, MD
University of Pittsburgh
Outcome results
None listed