Status:
COMPLETED
California Prehospital and In Hospital Antifibrinolytic Therapy Via TXA
Lead Sponsor:
Arrowhead Regional Medical Center
Conditions:
Hemorrhagic Shock
Trauma Injury
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief 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 ...
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 hemorrhagi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03469947
Start Date
March 1 2015
End Date
July 29 2024
Last Update
July 30 2024
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