Completed

NCT Number: NCT03532724

Clinical Outcomes From Patient Self-management of Antivitamin K Treatment

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Self Management of Oral Anticoagulation With VKA Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hspital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Self-Management of VKA therapy

Device

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

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

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

Death from any cause

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Retrospective Analysis of the Clinical Outcomes From Patient Self-management of Antivitamin K Treatment at the Hospitald de Sant Pau. ORION Study

Acronym: ORION

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: May 22, 2018
Registry last updated: Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.