California Prehospital and In Hospital Antifibrinolytic Therapy Via TXA

Arrowhead Regional Medical Center200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Hemorrhagic Shock Trauma Injury

Interventions

Tranexamic AcidDRUG

1 gram of prehospital Tranexamic Acid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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 1. Estimated blood loss of 500 milliliters int he field accompanied with HR \>120 2. Bleeding not controlled by direct pressure or tourniquet 3. 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

Outcomes

Primary Outcomes

Survival at 24 hours

Mortality at 24 hours

Time frame: 24 hours

Survival at 48 hours

Mortality at 48 hours

Time frame: 48 hours

Survival at 28 days

Mortality at 28 days

Time frame: 28 days

Secondary Outcomes

Blood Transfusion

Units of blood products needed (\<2 units, 2-4 units, \>4 units)

Time frame: 24 hours

Length of Hospital Stay

Duration of ICU stay

Time frame: 28 days

Adverse Events

Incidence of known adverse events associated with TXA

Time frame: 28 days

Data from ClinicalTrials.gov

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