NCT03532724CompletedNot Applicable
Retrospective Analysis of the Clinical Outcomes From Patient Self-management of Antivitamin K Treatment at the Hospitald de Sant Pau. ORION Study
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 site in 1 country927 target enrollmentStarted: November 1, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 927
- Locations
- 1
- Primary Endpoint
- Thromboembolic events
Study Overview
Brief Summary
ORION is a retrospective, observational, one center study to evaluate the incidence of complications (both thromboembolic and bleedings) in a cohort of patients receiving Vitamin K antagonists (VKA) under a self-management program, since 2002 at the Hospital de la Santa Creu i Sant Pau in Barcelona (Spain)
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients (older than 18) under chronic VKA treatment, whom performed patient self-management for any indication of oral anticoagulation.
- •Signed informed consent
Exclusion Criteria
- •Patients younger than 18 years old
Outcomes
Primary Outcomes
Thromboembolic events
Time Frame: since 1 of july of 2002 to 30th of june of 2018
Any documented embolic stroke, peripheral arterial embolism or venous thromboembolism
Major hemorrhagic event
Time Frame: since 1 of july of 2002 to 30th of june of 2018
Any documented bleeding event grade 3 or 5 in the Bleeding Assessment Research Consortium (BARC) scale
Secondary Outcomes
- Mortality(since 1 of july of 2002 to 30th of june of 2018)
Investigators
Study Sites (1)
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