California Prehospital and In Hospital Antifibrinolytic Therapy Via TXA (Cal-PAT)

July 29, 2024 updated by: Michael Neeki, Arrowhead Regional Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

200

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arrowhead Regional Medical Center

Investigators

  • Principal Investigator: Michael Neeki, Arrowhead Regional Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

July 29, 2024

Study Completion (Actual)

July 29, 2024

Study Registration Dates

First Submitted

March 8, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (Actual)

March 19, 2018

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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