Clinical Outcomes From Patient Self-management of Antivitamin K Treatment

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau927 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

927

Conditions

Self Management of Oral Anticoagulation With VKA Therapy

Interventions

Patient Self-Management of VKA therapyDEVICE

Trained patients check weekly the INR using a portable coagulometer an decide by themselves the dosis of VKA

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult patients (older than 18) under chronic VKA treatment, whom performed patient self-management for any indication of oral anticoagulation. 2. Signed informed consent Exclusion Criteria: 1\. Patients younger than 18 years old

Locations (1)

Hspital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Outcomes

Primary Outcomes

Thromboembolic events

Any documented embolic stroke, peripheral arterial embolism or venous thromboembolism

Time frame: since 1 of july of 2002 to 30th of june of 2018

Major hemorrhagic event

Any documented bleeding event grade 3 or 5 in the Bleeding Assessment Research Consortium (BARC) scale

Time frame: since 1 of july of 2002 to 30th of june of 2018

Secondary Outcomes

Mortality

Death from any cause

Time frame: since 1 of july of 2002 to 30th of june of 2018

Data from ClinicalTrials.gov

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