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

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ClinicalTrials.gov Identifier: NCT02086500
Recruitment Status : Recruiting
First Posted : March 13, 2014
Last Update Posted : October 18, 2018
Sponsor:
Collaborators:
University of Arizona
The University of Texas at San Antonio
University of Utah
Information provided by (Responsible Party):
Jason Sperry, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Traumatic Hemorrhage Drug: Tranexamic Acid Other: Saline control Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Prehospital Tranexamic Acid
1 gram of Tranexamic Acid will be given during emergency medical transport
Drug: Tranexamic Acid
1 gram of prehospital Tranexamic Acid

Placebo Comparator: Control
Identical volume of saline during emergency medical transport
Other: Saline control
Saline Control




Primary Outcome Measures :
  1. 30 Day Mortality [ Time Frame: 30 Day ]

Secondary Outcome Measures :
  1. 24 Hour Mortality [ Time Frame: 24 Hours ]
  2. Acute Lung Injury [ Time Frame: First 7 Days ]
  3. Multiple Organ Failure [ Time Frame: 30 Days ]
  4. Nosocomial Infection [ Time Frame: 30 Days ]
  5. 24 Hour Blood Transfusion [ Time Frame: 24 Hours ]
  6. Hyperfibrinolysis [ Time Frame: 24 Hours ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086500


Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jason L Sperry, MD,MPH    412-647-3065    sperryjl@upmd.edu   
Principal Investigator: Jason L Sperry, MD,MPH         
Sponsors and Collaborators
Jason Sperry
University of Arizona
The University of Texas at San Antonio
University of Utah

Responsible Party: Jason Sperry, MD, MPH, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02086500     History of Changes
Other Study ID Numbers: W81XWH1320080 IND 121102
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

Keywords provided by Jason Sperry, University of Pittsburgh:
Tranexamic acid
randomized
hemorrhage
blinded

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants