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

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:

1. 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

2. Within 2 hours of time of injury AND

3. 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

4. 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:

1. Age > 90 or < 18 years of age

2. Inability to obtain intravenous access or intraosseous

3. Documented (radiographic evidence) cervical cord injury with motor deficit

4. Known prisoner

5. Known pregnancy

6. Traumatic arrest with > 5 minutes CPR without return of vital signs

7. Penetrating cranial injury

8. Traumatic brain injury with brain matter exposed

9. Isolated drowning or hanging victims

10. Wearing an opt out bracelet.

11. Isolated fall from standing

12. Patient or Family Objection at scene