Clinical trial NCT02086500: Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial (STAAMP Trial)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Traumatic Hemorrhage
Keywords: Tranexamic acid
randomized
hemorrhage
blinded
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of Arizona
name: The University of Texas at San Antonio
name: University of Utah
First posted: 2014-03-13
Enrollment: 903
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 30 Day Mortality
timeFrame: 30 Day
Secondary outcomes:
measure: 24 Hour Mortality
timeFrame: 24 Hours
measure: Acute Lung Injury
timeFrame: 7 days
measure: Multiple Organ Failure
timeFrame: 30 days
measure: Nosocomial Infection
timeFrame: 30 days
measure: 24 Hour Total Blood Transfusion
timeFrame: 24 hours
measure: Hyperfinbrinolysis
timeFrame: 24 hours
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References:
citation: 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.