Phase 3
N=903
Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial (STAAMP Trial)
Traumatic Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT02086500 ↗Enrolled (actual)
903
Serious AEs
1.2%
Results posted
Sep 2020
Primary outcome: Primary: 30 Day Mortality — 36; 45 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tranexamic Acid (Drug); Saline control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Jason Sperry
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 30 Day Mortality |
36; 45 | — |
| SECONDARY 24 Hour Mortality |
16; 17 | — |
| SECONDARY Acute Lung Injury |
42; 39 | — |
| SECONDARY Multiple Organ Failure |
33; 39 | — |
| SECONDARY Nosocomial Infection |
88; 66 | — |
| SECONDARY 24 Hour Total Blood Transfusion |
0; 0 | — |
| SECONDARY Hyperfinbrinolysis |
145; 144 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
- Within 2 hours of time of injury AND
- Hypotension (Systolic Blood Pressure (SBP) 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
- Age > 90 or 5 minutes CPR without return of vital signs
- Penetrating cranial injury
- Traumatic brain injury with brain matter exposed
- Isolated drowning or hanging victims
- Wearing an opt out bracelet.
- Isolated fall from standing
- Patient or Family Objection at scene
Data sourced from ClinicalTrials.gov (NCT02086500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.