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

• ClinicalTrials.gov Identifier: NCT02086500
• Recruitment Status: Completed
• First Posted: March 13, 2014
• Results First Posted: September 10, 2020
• Last Update Posted: September 10, 2020
• Sponsor: Jason Sperry
• Collaborators: University of Arizona; The University of Texas at San Antonio; University of Utah
• Information provided by (Responsible Party): Jason Sperry, University of Pittsburgh

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.

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 903 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
• Actual Study Start Date: July 2015
• Actual Primary Completion Date: November 2019
• Actual Study Completion Date: November 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 30 Day Mortality [ Time Frame: 30 Day ]
   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 :

1. 24 Hour Mortality [ Time Frame: 24 Hours ]
2. Acute Lung Injury [ Time Frame: 7 days ]
3. Multiple Organ Failure [ Time Frame: 30 days ]
4. Nosocomial Infection [ Time Frame: 30 days ]
5. 24 Hour Total Blood Transfusion [ Time Frame: 24 hours ]
6. Hyperfinbrinolysis [ Time Frame: 24 hours ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Pennsylvania

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

Jason Sperry

University of Arizona

The University of Texas at San Antonio

University of Utah

  Study Documents (Full-Text)

Documents provided by Jason Sperry, University of Pittsburgh:

Study Protocol and Statistical Analysis Plan  [PDF] January 11, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. doi: 10.1001/jamasurg.2020.4350. [Epub ahead of print]

• Responsible Party: Jason Sperry, MD, MPH, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02086500
• Other Study ID Numbers: W81XWH1320080 IND 121102
• First Posted: March 13, 2014
• Results First Posted: September 10, 2020
• Last Update Posted: September 10, 2020
• Last Verified: September 2020

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