California Prehospital and In Hospital Antifibrinolytic Therapy Via TXA

Phase 3

Completed

• Conditions: Hemorrhagic Shock; Trauma Injury
• Interventions: Drug: Tranexamic Acid

• Registration Number: NCT03469947
• Lead Sponsor: Arrowhead Regional Medical Center

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 of traumatic hemorrhagic shock.

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 Timeline

• Study Start: 2015-03
• Study First Submitted: 2018-03-08
• Study First Submitted QC: 2018-03-16
• Study First Posted: 2018-03-19
• Status Verified: 2024-07
• Primary Completion: 2024-07-29
• Study Completion: 2024-07-29
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prehospital Tranexamic Acid	Tranexamic Acid	1 gram of Tranexamic Acid will be given during medical transport

Primary Outcome Measures

Name	Time	Method
Survival at 24 hours	24 hours	Mortality at 24 hours
Survival at 48 hours	48 hours	Mortality at 48 hours
Survival at 28 days	28 days	Mortality at 28 days

Secondary Outcome Measures

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