California Prehospital and In Hospital Antifibrinolytic Therapy Via TXA

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arrowhead Regional Medical Center
• Treatments: Antifibrinolytic Agents; Tranexamic Acid

Criteria

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