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

Traumatic Hemorrhage Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086500
• Other study ID #: W81XWH1320080 IND 121102
• Status: Completed
• Phase: Phase 3
• Start date: July 2015
• Est. completion date: November 2019

Study information

• Verified date: September 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 903
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Traumatic Hemorrhage

Intervention

Drug:
• Tranexamic Acid
1 gram of prehospital Tranexamic Acid

Other:
• Saline control
Saline Control

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Jason Sperry	The University of Texas at San Antonio, University of Arizona, University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 Day
Secondary	24 Hour Mortality		24 Hours
Secondary	Acute Lung Injury		7 days
Secondary	Multiple Organ Failure		30 days
Secondary	Nosocomial Infection		30 days
Secondary	24 Hour Total Blood Transfusion		24 hours
Secondary	Hyperfinbrinolysis		24 hours