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

Arrowhead Regional Medical Center

Status and phase: Completed; Phase 3

Conditions: Trauma Injury; Hemorrhagic Shock

Treatments: Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03469947

2018-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Prehospital Tranexamic Acid

Experimental group

Description:

1 gram of Tranexamic Acid will be given during medical transport

Treatment:

Drug: Tranexamic Acid

Matched Controls

No Intervention group

Description:

Retrospective matched controls