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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

903 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Traumatic Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Prehospital Tranexamic Acid

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

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

1 gram of prehospital Tranexamic Acid

Control

Identical volume of saline during emergency medical transport

Group Type PLACEBO_COMPARATOR

Saline control

Intervention Type OTHER

Saline Control

Interventions

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Tranexamic Acid

1 gram of prehospital Tranexamic Acid

Intervention Type DRUG

Saline control

Saline Control

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No