Recruitment

Recruitment Status
Completed
Estimated Enrollment
1000

Inclusion Criteria

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
...
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
Documented at referring hospital prior to air or ground medical transport arrival
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
At scene of injury or during air or ground medical transport

Exclusion Criteria

Inability to obtain intravenous access or intraosseous
Traumatic brain injury with brain matter exposed
Penetrating cranial injury
...
Inability to obtain intravenous access or intraosseous
Traumatic brain injury with brain matter exposed
Penetrating cranial injury
Documented (radiographic evidence) cervical cord injury with motor deficit
Patient or Family Objection at scene
Isolated drowning or hanging victims
Traumatic arrest with > 5 minutes CPR without return of vital signs
Age > 90 or < 18 years of age
Isolated fall from standing
Known prisoner
Wearing an opt out bracelet.
Known pregnancy

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
At scene of injury or during air or ground medical transport
Within 2 hours of time of injury AND
...
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
Documented at referring hospital prior to air or ground medical transport arrival
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
At scene of injury or during air or ground medical transport

Exclusion Criteria

Inability to obtain intravenous access or intraosseous
Traumatic brain injury with brain matter exposed
Penetrating cranial injury
...
Inability to obtain intravenous access or intraosseous
Traumatic brain injury with brain matter exposed
Penetrating cranial injury
Documented (radiographic evidence) cervical cord injury with motor deficit
Patient or Family Objection at scene
Isolated drowning or hanging victims
Traumatic arrest with > 5 minutes CPR without return of vital signs
Age > 90 or < 18 years of age
Isolated fall from standing
Known prisoner
Wearing an opt out bracelet.
Known pregnancy

Tracking Information

NCT #
NCT02086500
Collaborators
  • University of Arizona
  • The University of Texas at San Antonio
  • University of Utah
Investigators
Not Provided