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

• Status: Completed
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jason Sperry; University of Pittsburgh
• Collaborators: The University of Texas at San Antonio; University of Arizona; University of Utah
• Treatments: Tranexamic Acid

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