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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 : September 12, 2019
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

Tracking Information
First Submitted Date  ICMJE March 6, 2014
First Posted Date  ICMJE March 13, 2014
Last Update Posted Date September 12, 2019
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2014)
30 Day Mortality [ Time Frame: 30 Day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02086500 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial (STAAMP Trial)
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Hemorrhage
Intervention  ICMJE
  • Drug: Tranexamic Acid
    1 gram of prehospital Tranexamic Acid
  • Other: Saline control
    Saline Control
Study Arms  ICMJE
  • Experimental: Prehospital Tranexamic Acid
    1 gram of Tranexamic Acid will be given during emergency medical transport
    Intervention: Drug: Tranexamic Acid
  • Placebo Comparator: Control
    Identical volume of saline during emergency medical transport
    Intervention: Other: Saline control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 11, 2014)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02086500
Other Study ID Numbers  ICMJE W81XWH1320080 IND 121102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jason Sperry, University of Pittsburgh
Study Sponsor  ICMJE Jason Sperry
Collaborators  ICMJE
  • University of Arizona
  • The University of Texas at San Antonio
  • University of Utah
Investigators  ICMJE Not Provided
PRS Account University of Pittsburgh
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP