California Prehospital and In Hospital Antifibrinolytic Therapy Via TXA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2024-07-29

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.

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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.

Conditions

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Hemorrhagic Shock Trauma Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Prospective observational cohort administered TXA prehospital and a retrospective cohort for matched controls.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prehospital Tranexamic Acid

1 gram of Tranexamic Acid will be given during medical transport

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

1 gram of prehospital Tranexamic Acid

Matched Controls

Retrospective matched controls

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tranexamic Acid

1 gram of prehospital Tranexamic Acid

Intervention Type DRUG

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No