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Phase 3 Completed N=903 Randomized Quadruple-blind Treatment

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

Source: ClinicalTrials.gov NCT02086500 ↗
Enrolled (actual)
903
Serious AEs
1.2%
Results posted
Sep 2020
Primary outcomePrimary: 30 Day Mortality — 36; 45 Participants
◆ Published Evidence
Highly cited
121citations · ~20 / year
Tranexamic Acid During Prehospital Transport in Patients at Risk for Hemorrhage After Injury: A Double-blind, Placebo-Controlled, Randomized Clinical Trial.
JAMA surgery · 2020 · Open access · Likely link

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.

Linked Publications (3)

  • Tranexamic Acid During Prehospital Transport in Patients at Risk for Hemorrhage After Injury: A Double-blind, Placebo-Controlled, Randomized Clinical Trial.
    JAMA surgery · 2020 · 121 citations · Open access · Likely link
  • Prehospital tranexamic acid is associated with a dose-dependent decrease in syndecan-1 after trauma: A secondary analysis of a prospective randomized trial.
    The journal of trauma and acute care surgery · 2023 · 16 citations · Open access · Likely link
  • Characterization of adverse events in injured patients at risk of hemorrhagic shock: a secondary analysis of three harmonized prehospital randomized clinical trials.
    Trauma surgery & acute care open · 2024 · 0 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02086500) and the linked publication. 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. Informational only — not medical advice.

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