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Completed

NCT Number: NCT03469947

California Prehospital and In Hospital Antifibrinolytic Therapy Via TXA

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

1 gram of prehospital Tranexamic Acid

Primary outcomes

  1. Survival at 24 hours

    Time frame: 24 hours

    Mortality at 24 hours

  2. Survival at 48 hours

    Time frame: 48 hours

    Mortality at 48 hours

  3. Survival at 28 days

    Time frame: 28 days

    Mortality at 28 days

Secondary outcomes

  1. Blood Transfusion

    Time frame: 24 hours

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

  2. Length of Hospital Stay

    Time frame: 28 days

    Duration of ICU stay

  3. Adverse Events

    Time frame: 28 days

    Incidence of known adverse events associated with TXA

Sponsors and collaborators

Lead sponsor

Arrowhead Regional Medical Center

Other

Registry information

Official study title

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

Acronym: Cal-PAT

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2018
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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