A Phase 3 interventional study of low titer whole blood and Standard Care in Hemorrhagic Shock and Traumatic Injury, sponsored by Jason Sperry. Completed at 10 sites in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Jason Sperry · Phase 3, Interventional, and Treatment
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.
79 studies on the registry are indexed under Shock, Hemorrhagic; 15 are open to participants now.
This study's enrollment of 1,020 is above the median of 107 across 42 interventional studies indexed under Shock, Hemorrhagic.
Browse Shock, Hemorrhagic studies →Jason Sperry is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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.
Biological: low titer whole blood
Subjects will receive prehospital crystalloid infusion or blood component transfusion resuscitation per site standard care for the respective Emergency Medical unit/service.
Biological: Standard Care
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
crystalloid infusion or blood component transfusion resuscitation
30-day mortality
All cause mortality within 30 days
Time frame: Enrollment through 30 days
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
Time frame: During Procedure
3-hour mortality
Death within 3 hours of enrollment
Time frame: Enrollment through 3 hours
6-hour mortality
Death within 6 hours of enrollment
Time frame: Enrollment through 6 hours
24-hour mortality
Death within 24 hours of enrollment
Time frame: Enrollment through 24 hours
In-hospital mortality
Death prior to hospital discharge
Time frame: Enrollment through hospital discharge or 30 days
Time to death
Time in days from enrollment to death
Time frame: Enrollment through death or 30 days
Blood and blood component transfusion type
Type of blood or blood component required for transfusion
Time frame: Enrollment through 24 hours
Blood and blood component transfusion amount
Number of units of blood or blood component transfused
Time frame: Enrollment through 24 hours
Time to blood and blood component transfusion
Amount of time from enrollment to transfusion of blood or blood component
Time frame: Enrollment time to first transfusion
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.
Time frame: Enrollment through 7 days or ICU discharge
Hospital-acquired pneumonia
Pneumonia acquired during hospitalization per Center for Disease Control (CDC) criteria
Time frame: Number of participants who develop pneumonia through 30 days
blood stream infection
Blood stream infection during hospitalization per CDC criteria
Time frame: Number of participants who develop blood stream infection through 30 days
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).
Time frame: Number of participants who develop ARDS through 30 days
Prothrombin Time (PT)
Measurement of platelet hemostatic function
Time frame: Enrollment through 60 minutes and 24 hours
International Normalized Ratio (INR)
Measurement of platelet hemostatic function
Time frame: Enrollment through 60 minutes and 24 hours
Incidence of coagulopathy by rapid thrombelastography (rTEG)
Coagulopathy as indicated by rTEG measures
Time frame: Enrollment through 60 minutes and 24 hours
rTEG platelet function
rTEG measurement of platelet hemostatic function
Time frame: Enrollment through 60 minutes and 24 hours
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
Time frame: Enrollment through 4 hours
Transfusion reaction
Any transfusion complication
Time frame: Enrollment through 24 hours
whole blood aggregometry
platelet function test using low-dose collagen as a stimulus
Time frame: Enrollment through 60 minutes
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator.
Supporting information: Study protocol, Informed consent form
Time frame: Data will become available after publication of the primary manuscript.
Access criteria: Requests for data will be submitted in writing and reviewed by the Principal Investigator.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Jason Sperry