California Prehospital and In Hospital Antifibrinolytic Therapy Via TXA

Study Overview
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Brief Summary
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The California Prehospital Antifibrinolytic Therapy (Cal-PAT) study seeks to evaluate the safety and efficacy of Tranexamic Acid (TXA) use in the civilian prehospital and in hospital setting in cases of traumatic hemorrhagic shock.

Detailed Description
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The Cal-PAT study is a multi-centered, prospective, observational cohort study. From March 2015 to July 2017, patients ≥ 18-years-old who sustained blunt or penetrating trauma with signs of hemorrhagic shock identified were considered for TXA treatment by first responders in the prehospital setting and physicians in hospital. A control group was formed of patients seen in the five years prior to data collection cessation (June 2012 to July 2017) at each receiving center who were not administered TXA. Control group patients were selected through propensity score matching based on gender, age, injury severity scores, and mechanism of injury. The primary outcome measured was mortality. Secondary outcomes measured included the total blood products transfused, the hospital and intensive care unit length of stay, and the incidence of known adverse events associated with TXA.

Official Title
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Tranexamic Acid in Prehospital and In Hospital Civilian Trauma Care in Antifibrinolytic Therapy Study

Conditions
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Hemorrhagic Shock, Trauma Injury

Intervention / Treatment
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* Drug: Tranexamic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Blunt or penetrating trauma with signs and symptoms of hemorrhagic shock Systolic blood pressure less than 90 mmHg at scene of injury, during air and/or ground medical transport, or on arrival to designated trauma centers Any sustained blunt or penetrating injury within 3 hours Patient who are considered to be at high risk for significant hemorrhage Estimated blood loss of 500 milliliters int he field accompanied with HR >120 Bleeding not controlled by direct pressure or tourniquet Major amputation of any extremity above the wrists and above the ankles Exclusion Criteria: Any patient under 18 years of age Any patient with an active thromboembolic event (within the last 24 hours) i.e. active stroke, myocardial infarction, or pulmonary embolism Any patient with a hypersensitivity or anaphylactic reaction to TXA Any patient more than 3 hours post injury 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 Documented cervical cord injury with motor deficit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective observational cohort administered TXA prehospital and a retrospective cohort for matched controls.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehospital Tranexamic Acid<br>1 gram of Tranexamic Acid will be given during medical transport | Drug: Tranexamic Acid<br>* 1 gram of prehospital Tranexamic Acid<br>|
| No Intervention: Matched Controls<br>Retrospective matched controls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival at 24 hours | Mortality at 24 hours | 24 hours | 
| Survival at 48 hours | Mortality at 48 hours | 48 hours | 
| Survival at 28 days | Mortality at 28 days | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Transfusion | Units of blood products needed (<2 units, 2-4 units, >4 units) | 24 hours | 
| Length of Hospital Stay | Duration of ICU stay | 28 days | 
| Adverse Events | Incidence of known adverse events associated with TXA | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tranexamic Acid, TXA