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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-16-D-0024 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole Blood | Experimental | 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 | Active Comparator | Subjects will receive prehospital crystalloid infusion or blood component transfusion resuscitation per site standard care for the respective Emergency Medical unit/service. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low titer whole blood | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day mortality | All cause mortality within 30 days | Enrollment through 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 3-hour mortality |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Jason L Sperry, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of Louisville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42150044 | Derived | Sperry JL, Guyette FX, Cotton BA, Luther JF, Utarnachitt RB, Kutcher ME, Daley BJ, Peetz AB, Patel MB, Goodman MD, Claridge JA, Patel N, Harbrecht BG, Hashmi ZG, Zarychanski R, Neal MD, Yazer MH, Martin-Gill C, Vincent LE, Harner AM, Meyer DE, Latimer AJ, Robinson BR, McKnight CL, Hinckley WR, Miller KR, Jansen JO, Martin D, Fox EE, Rosario-Rivera BL, Wisniewski SR; TOWAR Study Group. Prehospital Resuscitation with Type O Whole Blood for Trauma and Hemorrhage. N Engl J Med. 2026 Jun 18;394(23):2317-2328. doi: 10.1056/NEJMoa2602167. Epub 2026 May 18. | |
| 40271704 |
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De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator.
Data will become available after publication of the primary manuscript.
Requests for data will be submitted in writing and reviewed by the Principal Investigator.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2022 |
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| Standard Care | Biological | crystalloid infusion or blood component transfusion resuscitation |
|
Death within 3 hours of enrollment
| Enrollment through 3 hours |
| 6-hour mortality | Death within 6 hours of enrollment | Enrollment through 6 hours |
| 24-hour mortality | Death within 24 hours of enrollment | Enrollment through 24 hours |
| In-hospital mortality | Death prior to hospital discharge | Enrollment through hospital discharge or 30 days |
| Time to death | Time in days from enrollment to death | Enrollment through death or 30 days |
| Blood and blood component transfusion type | Type of blood or blood component required for transfusion | Enrollment through 24 hours |
| Blood and blood component transfusion amount | Number of units of blood or blood component transfused | Enrollment through 24 hours |
| Time to blood and blood component transfusion | Amount of time from enrollment to transfusion of blood or blood component | 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. | Enrollment through 7 days or ICU discharge |
| Hospital-acquired pneumonia | Pneumonia acquired during hospitalization per Center for Disease Control (CDC) criteria | Number of participants who develop pneumonia through 30 days |
| blood stream infection | Blood stream infection during hospitalization per CDC criteria | 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). | Number of participants who develop ARDS through 30 days |
| Prothrombin Time (PT) | Measurement of platelet hemostatic function | Enrollment through 60 minutes and 24 hours |
| International Normalized Ratio (INR) | Measurement of platelet hemostatic function | Enrollment through 60 minutes and 24 hours |
| Incidence of coagulopathy by rapid thrombelastography (rTEG) | Coagulopathy as indicated by rTEG measures | Enrollment through 60 minutes and 24 hours |
| rTEG platelet function | rTEG measurement of platelet hemostatic function | 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 | Enrollment through 4 hours |
| Transfusion reaction | Any transfusion complication | Enrollment through 24 hours |
| whole blood aggregometry | platelet function test using low-dose collagen as a stimulus | Enrollment through 60 minutes |
| Louisville |
| Kentucky |
| 40292 |
| United States |
| University of Mississippi Medical Center (UMMC) | Jackson | Mississippi | 39216 | United States |
| University of Cincinatti | Cincinnati | Ohio | 45267 | United States |
| Metrohealth Systems | Cleveland | Ohio | 44109 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| Derived |
| Brunskill SJ, Disegna A, Wong H, Fabes J, Desborough MJ, Doree C, Davenport R, Curry N, Stanworth SJ. Blood transfusion strategies for major bleeding in trauma. Cochrane Database Syst Rev. 2025 Apr 24;4(4):CD012635. doi: 10.1002/14651858.CD012635.pub2. |
| 38531812 | Derived | Meizoso JP, Cotton BA, Lawless RA, Kodadek LM, Lynde JM, Russell N, Gaspich J, Maung A, Anderson C, Reynolds JM, Haines KL, Kasotakis G, Freeman JJ. Whole blood resuscitation for injured patients requiring transfusion: A systematic review, meta-analysis, and practice management guideline from the Eastern Association for the Surgery of Trauma. J Trauma Acute Care Surg. 2024 Sep 1;97(3):460-470. doi: 10.1097/TA.0000000000004327. Epub 2024 Mar 27. |
| Aug 12, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2024 | Aug 12, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D012771 | Shock, Hemorrhagic |
| D014947 | Wounds and Injuries |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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