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

Primary Purpose

Traumatic Hemorrhage

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Saline control
Sponsored by
Jason Sperry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Hemorrhage focused on measuring Tranexamic acid, randomized, hemorrhage, blinded

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prehospital Tranexamic Acid

Control

Arm Description

1 gram of Tranexamic Acid will be given during emergency medical transport

Identical volume of saline during emergency medical transport

Outcomes

Primary Outcome Measures

30 Day Mortality
Because not all patients had available data regarding 30-day mortality (patients were discharged and there 30-day outcome was unable to be determined) there may be differences between the 30Day mortality relative to the other outcomes. There were 5 and 4 patients from each arm that did not have 30-day outcome and thus are different.

Secondary Outcome Measures

24 Hour Mortality
Acute Lung Injury
Multiple Organ Failure
Nosocomial Infection
24 Hour Total Blood Transfusion
Hyperfinbrinolysis

Full Information

First Posted
March 6, 2014
Last Updated
September 9, 2020
Sponsor
Jason Sperry
Collaborators
University of Arizona, The University of Texas at San Antonio, University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT02086500
Brief Title
Study of Tranexamic Acid During Air and Ground Medical Prehospital Transport Trial (STAAMP Trial)
Acronym
STAAMP
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 Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jason Sperry
Collaborators
University of Arizona, The University of Texas at San Antonio, University of Utah

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Hemorrhage
Keywords
Tranexamic acid, randomized, hemorrhage, blinded

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
903 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prehospital Tranexamic Acid
Arm Type
Experimental
Arm Description
1 gram of Tranexamic Acid will be given during emergency medical transport
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Identical volume of saline during emergency medical transport
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
1 gram of prehospital Tranexamic Acid
Intervention Type
Other
Intervention Name(s)
Saline control
Intervention Description
Saline Control
Primary Outcome Measure Information:
Title
30 Day Mortality
Description
Because not all patients had available data regarding 30-day mortality (patients were discharged and there 30-day outcome was unable to be determined) there may be differences between the 30Day mortality relative to the other outcomes. There were 5 and 4 patients from each arm that did not have 30-day outcome and thus are different.
Time Frame
30 Day
Secondary Outcome Measure Information:
Title
24 Hour Mortality
Time Frame
24 Hours
Title
Acute Lung Injury
Time Frame
7 days
Title
Multiple Organ Failure
Time Frame
30 days
Title
Nosocomial Infection
Time Frame
30 days
Title
24 Hour Total Blood Transfusion
Time Frame
24 hours
Title
Hyperfinbrinolysis
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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) < 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 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: Age > 90 or < 18 years of age Inability to obtain intravenous access or intraosseous Documented (radiographic evidence) cervical cord injury with motor deficit Known prisoner Known pregnancy Traumatic arrest with > 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
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33016996
Citation
Guyette FX, Brown JB, Zenati MS, Early-Young BJ, Adams PW, Eastridge BJ, Nirula R, Vercruysse GA, O'Keeffe T, Joseph B, Alarcon LH, Callaway CW, Zuckerbraun BS, Neal MD, Forsythe RM, Rosengart MR, Billiar TR, Yealy DM, Peitzman AB, Sperry JL; STAAMP Study Group. Tranexamic Acid During Prehospital Transport in Patients at Risk for Hemorrhage After Injury: A Double-blind, Placebo-Controlled, Randomized Clinical Trial. JAMA Surg. 2020 Oct 5;156(1):11-20. doi: 10.1001/jamasurg.2020.4350. Online ahead of print. Erratum In: JAMA Surg. 2021 Jan 1;156(1):105.
Results Reference
derived

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

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