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Trial record 1 of 3 for:    STAAMP
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Study of Tranexamic Acid During Air Medical Prehospital Transport Trial (STAAMP Trial) (STAAMP)

This study is currently recruiting participants.
Verified September 2017 by Jason Sperry, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT02086500
First Posted: March 13, 2014
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Arizona
The University of Texas at San Antonio
University of Utah
Information provided by (Responsible Party):
Jason Sperry, University of Pittsburgh
  Purpose
The purpose of this study is to determine if 1 gram of prehospital tranexamic acid given during air medical transport to a level 1 trauma center in patients at risk of hemorrhage is associated with lower 30 day mortality.

Condition Intervention Phase
Traumatic Hemorrhage Drug: Tranexamic Acid Other: Saline control Phase 3

Study Type: Interventional
Study Design: 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 Medical Prehospital Transport Trial For Trauma Patients At Risk Of Hemorrhage (STAAMP Trial); Phase III Multicenter, Prospective, Randomized, Double Blind, Interventional Trial

Resource links provided by NLM:


Further study details as provided by Jason Sperry, University of Pittsburgh:

Primary Outcome Measures:
  • 30 Day Mortality [ Time Frame: 30 Day ]

Secondary Outcome Measures:
  • 24 Hour Mortality [ Time Frame: 24 Hours ]
  • Acute Lung Injury [ Time Frame: First 7 Days ]
  • Multiple Organ Failure [ Time Frame: 30 Days ]
  • Nosocomial Infection [ Time Frame: 30 Days ]
  • 24 Hour Blood Transfusion [ Time Frame: 24 Hours ]
  • Hyperfibrinolysis [ Time Frame: 24 Hours ]

Estimated Enrollment: 1000
Study Start Date: July 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prehospital Tranexamic Acid
1 gram of Tranexamic Acid will be given during air medical transport
Drug: Tranexamic Acid
1 gram of prehospital Tranexamic Acid
Placebo Comparator: Control
Identical volume of saline during air medical transport
Other: Saline control
Saline Control

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

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Blunt or penetrating injured patients being transported via air 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 medical transport
    • Documented at referring hospital prior to air medical transport arrival

    OR

  4. Tachycardia (heart rate >110 beats per minute)

    • At scene of injury or during air medical transport
    • Documented at referring hospital prior to air medical transport arrival Inclusion criteria #3. and #4. not required to be simultaneous

Exclusion Criteria:

  1. Age > 90 or < 18 years of age
  2. Inability to obtain intravenous access (intraosseous access not sufficient)
  3. Documented 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
  Contacts and Locations
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
University of Pittsburgh
University of Arizona
The University of Texas at San Antonio
University of Utah
  More Information

Responsible Party: Jason Sperry, MD, MPH, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02086500     History of Changes
Other Study ID Numbers: W81XWH1320080 IND 121102
First Submitted: March 6, 2014
First Posted: March 13, 2014
Last Update Posted: September 15, 2017
Last Verified: September 2017

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