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| Name | Class |
|---|---|
| University of Arizona | OTHER |
| The University of Texas at San Antonio | OTHER |
| University of Utah | OTHER |
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The purpose of this study is to determine if 1 gram of prehospital tranexamic acid given during emergency medical transport to a level 1 trauma center in patients at risk of hemorrhage is associated with lower 30 day mortality.
Background: Traumatically injured patients continue to be plagued with uncontrolled hemorrhage resulting in significant morbidity and early mortality. A primary driving force for this unbridled hemorrhage is known to be the early coagulopathy which complicates severe injury. Trauma induced coagulopathy has been postulated to be an equilibrium imbalance between pro and anticoagulant factors, platelets, endothelium and fibrinolysis soon after injury. Recent evidence demonstrates that the early use of the antifibrinolytic agent tranexamic acid (TXA) after trauma center arrival results in improved survival in patients at risk for bleeding. Bringing this proven treatment to the prehospital arena and intervening earlier in those patients who would otherwise not be candidates for treatment has the real potential to further reduce or prevent the vicious hemorrhagic cascade, improve clinical outcomes and provide insight into the underlying mechanisms responsible for and which maximize its benefit.
Objective/Hypothesis: The primary hypothesis will be that prehospital infusion of tranexamic acid in patients at risk for bleeding will reduce the incidence of 30 day mortality. The secondary hypotheses include that prehospital tranexamic acid will reduce the incidence of hyperfibrinolysis, acute lung injury, multiple organ failure, nosocomial infection, mortality, early seizures, pulmonary embolism and early resuscitation needs, reduce or prevent the early coagulopathy as demonstrated by improving presenting INR and rapid thromboelastography parameters, reduce the early inflammatory response, plasmin levels, leukocyte, platelet and complement activation, and determine the optimal dosing of tranexamic acid post-injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehospital Tranexamic Acid | Experimental | 1 gram of Tranexamic Acid will be given during emergency medical transport |
|
| Control | Placebo Comparator | Identical volume of saline during emergency medical transport |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 1 gram of prehospital Tranexamic Acid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 30 Day Mortality | Because not all patients had available data regarding 30-day mortality (patients were discharged and there 30-day outcome was unable to be determined) there may be differences between the 30Day mortality relative to the other outcomes. There were 5 and 4 patients from each arm that did not have 30-day outcome and thus are different. | 30 Day |
| Measure | Description | Time Frame |
|---|---|---|
| 24 Hour Mortality | 24 Hours | |
| Acute Lung Injury | 7 days | |
| Multiple Organ Failure |
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Inclusion Criteria:
Blunt or penetrating injured patients at risk of bleeding being transported via air or ground medical services from the scene of injury or from referring hospital to a definitive trauma center that is participating in the trial AND
Within 2 hours of time of injury AND
Hypotension (Systolic Blood Pressure (SBP) < 90mmHg)
OR
Tachycardia (heart rate >110 beats per minute)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38933603 | Derived | Lorence JM, Donohue JK, Iyanna N, Guyette FX, Gimbel E, Brown JB, Daley BJ, Eastridge BJ, Miller RS, Nirula R, Harbrecht BG, Claridge JA, Phelan HA, Vercruysse G, O'Keeffe T, Joseph B, Neal MD, Sperry JL. Characterization of adverse events in injured patients at risk of hemorrhagic shock: a secondary analysis of three harmonized prehospital randomized clinical trials. Trauma Surg Acute Care Open. 2024 Jun 25;9(1):e001465. doi: 10.1136/tsaco-2024-001465. eCollection 2024. | |
| 37125811 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prehospital Tranexamic Acid | 1 gram of Tranexamic Acid will be given during emergency medical transport Tranexamic Acid: 1 gram of prehospital Tranexamic Acid |
| FG001 | Control | Identical volume of saline during emergency medical transport Saline control: Saline Control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
of the 927 patients enrolled in the prehospital environment, 903 were able to be analyzed
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| ID | Title | Description |
|---|---|---|
| BG000 | Prehospital Tranexamic Acid | 1 gram of Tranexamic Acid will be given during emergency medical transport Tranexamic Acid: 1 gram of prehospital Tranexamic Acid |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 30 Day Mortality | Because not all patients had available data regarding 30-day mortality (patients were discharged and there 30-day outcome was unable to be determined) there may be differences between the 30Day mortality relative to the other outcomes. There were 5 and 4 patients from each arm that did not have 30-day outcome and thus are different. | Because not all patients had available data regarding 30-day mortality (patients were discharged and there 30-day outcome was unable to be determined) there may be differences between the 30Day mortality relative to the other outcomes. There were 5 and 4 patients from each arm that did not have 30-day outcome and thus are different. | Posted | Count of Participants | Participants | 30 Day |
|
Hospital Admission to 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prehospital Tranexamic Acid | 1 gram of Tranexamic Acid will be given during emergency medical transport Tranexamic Acid: 1 gram of prehospital Tranexamic Acid |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Systematic Assessment | Stroke |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ileus | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Sperry MD, MPH | University of Pittsburgh | 4128028270 | sperryjl@upmc.edu |
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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 | Jan 11, 2019 | Jul 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Saline control |
| Other |
Saline Control |
|
| 30 days |
| Nosocomial Infection | 30 days |
| 24 Hour Total Blood Transfusion | 24 hours |
| Hyperfinbrinolysis | 24 hours |
| Derived |
| Gruen DS, Brown JB, Guyette FX, Johansson PI, Stensballe J, Li SR, Leeper CM, Eastridge BJ, Nirula R, Vercruysse GA, O'Keeffe T, Joseph B, Neal MD, Sperry JL. Prehospital tranexamic acid is associated with a dose-dependent decrease in syndecan-1 after trauma: A secondary analysis of a prospective randomized trial. J Trauma Acute Care Surg. 2023 Nov 1;95(5):642-648. doi: 10.1097/TA.0000000000003955. Epub 2023 May 1. |
| 33016996 | Derived | Guyette FX, Brown JB, Zenati MS, Early-Young BJ, Adams PW, Eastridge BJ, Nirula R, Vercruysse GA, O'Keeffe T, Joseph B, Alarcon LH, Callaway CW, Zuckerbraun BS, Neal MD, Forsythe RM, Rosengart MR, Billiar TR, Yealy DM, Peitzman AB, Sperry JL; STAAMP Study Group. Tranexamic Acid During Prehospital Transport in Patients at Risk for Hemorrhage After Injury: A Double-blind, Placebo-Controlled, Randomized Clinical Trial. JAMA Surg. 2020 Oct 5;156(1):11-20. doi: 10.1001/jamasurg.2020.4350. Online ahead of print. |
Identical volume of saline during emergency medical transport
Saline control: Saline Control
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Control | Identical volume of saline during emergency medical transport Saline control: Saline Control |
|
|
| Secondary | 24 Hour Mortality | Posted | Count of Participants | Participants | 24 Hours |
|
|
|
| Secondary | Acute Lung Injury | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Multiple Organ Failure | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Nosocomial Infection | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | 24 Hour Total Blood Transfusion | Posted | Median | Inter-Quartile Range | units of blood transfusion | 24 hours |
|
|
|
| Secondary | Hyperfinbrinolysis | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| 36 |
| 447 |
| 4 |
| 447 |
| 4 |
| 447 |
| EG001 | Control | Identical volume of saline during emergency medical transport Saline control: Saline Control | 45 | 456 | 7 | 456 | 14 | 456 |
| MI | Cardiac disorders | Systematic Assessment |
|
| Pulmonary Embolus | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Arterial Thromboembolic event NOS | Blood and lymphatic system disorders | Systematic Assessment |
|
| Metabolic Acidosis | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | Systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Pulmonary Embolus | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pnuemonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Venous Thromboembolic Event NOS | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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