Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial (STAAMP Trial)
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 1000
Inclusion Criteria
- Documented at referring hospital prior to air or ground medical transport arrival
- Documented at referring hospital prior to air or ground medical transport arrival
- At scene of injury or during air or ground medical transport
- ...
- Documented at referring hospital prior to air or ground medical transport arrival
- Documented at referring hospital prior to air or ground medical transport arrival
- At scene of injury or during air or ground medical transport
- Within 2 hours of time of injury AND
- At scene of injury or during air or ground medical transport
- 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
Exclusion Criteria
- Inability to obtain intravenous access or intraosseous
- Isolated fall from standing
- Traumatic arrest with > 5 minutes CPR without return of vital signs
- ...
- Inability to obtain intravenous access or intraosseous
- Isolated fall from standing
- Traumatic arrest with > 5 minutes CPR without return of vital signs
- Traumatic brain injury with brain matter exposed
- Penetrating cranial injury
- Known prisoner
- Wearing an opt out bracelet.
- Documented (radiographic evidence) cervical cord injury with motor deficit
- Age > 90 or < 18 years of age
- Isolated drowning or hanging victims
- Known pregnancy
- Patient or Family Objection at scene
Summary
- Conditions
- Traumatic Hemorrhage
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 90 years
- Gender
- Both males and females
Description
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 coagulopa...
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.
Inclusion Criteria
- Documented at referring hospital prior to air or ground medical transport arrival
- Documented at referring hospital prior to air or ground medical transport arrival
- At scene of injury or during air or ground medical transport
- ...
- Documented at referring hospital prior to air or ground medical transport arrival
- Documented at referring hospital prior to air or ground medical transport arrival
- At scene of injury or during air or ground medical transport
- Within 2 hours of time of injury AND
- At scene of injury or during air or ground medical transport
- 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
Exclusion Criteria
- Inability to obtain intravenous access or intraosseous
- Isolated fall from standing
- Traumatic arrest with > 5 minutes CPR without return of vital signs
- ...
- Inability to obtain intravenous access or intraosseous
- Isolated fall from standing
- Traumatic arrest with > 5 minutes CPR without return of vital signs
- Traumatic brain injury with brain matter exposed
- Penetrating cranial injury
- Known prisoner
- Wearing an opt out bracelet.
- Documented (radiographic evidence) cervical cord injury with motor deficit
- Age > 90 or < 18 years of age
- Isolated drowning or hanging victims
- Known pregnancy
- Patient or Family Objection at scene
Tracking Information
- NCT #
- NCT02086500
- Collaborators
- University of Arizona
- The University of Texas at San Antonio
- University of Utah
- Investigators
- Not Provided