Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial (STAAMP Trial)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial For Trauma Patients At Risk Of Hemorrhage (STAAMP Trial); Phase III Multicenter, Prospective, Randomized, Double Blind, Interventional Trial

Conditions
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Traumatic Hemorrhage

Intervention / Treatment
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* Drug: Tranexamic Acid
* Other: Saline control


Participation Criteria
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Eligibility Criteria
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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) At scene of injury or during air or ground medical transport Documented at referring hospital prior to air or ground medical transport arrival OR Tachycardia (heart rate >110 beats per minute) At scene of injury or during air or ground medical transport Documented at referring hospital prior to air or ground medical transport arrival Exclusion Criteria: Age > 90 or < 18 years of age Inability to obtain intravenous access or intraosseous Documented (radiographic evidence) cervical cord injury with motor deficit Known prisoner Known pregnancy Traumatic arrest with > 5 minutes CPR without return of vital signs Penetrating cranial injury Traumatic brain injury with brain matter exposed Isolated drowning or hanging victims Wearing an opt out bracelet. Isolated fall from standing Patient or Family Objection at scene

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehospital Tranexamic Acid<br>1 gram of Tranexamic Acid will be given during emergency medical transport | Drug: Tranexamic Acid<br>* 1 gram of prehospital Tranexamic Acid<br>|
| Placebo Comparator: Control<br>Identical volume of saline during emergency medical transport | Other: Saline control<br>* Saline Control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 Hour Mortality |  | 24 Hours | 
| Acute Lung Injury |  | 7 days | 
| Multiple Organ Failure |  | 30 days | 
| Nosocomial Infection |  | 30 days | 
| 24 Hour Total Blood Transfusion |  | 24 hours | 
| Hyperfinbrinolysis |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tranexamic acid, randomized, hemorrhage, blinded