Clinical Outcomes From Patient Self-management of Antivitamin K Treatment (ORION)

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

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 Overview

• Status: Completed
• Conditions: Self Management of Oral Anticoagulation With VKA Therapy
• Intervention / Treatment: Device: Patient Self-Management of VKA therapy

• Study Type: Observational
• Enrollment (Actual): 927

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08025
      • Hspital de la Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from atrial fibrillation, or carrying a cardiac mechanical valve prostheses, or suffering any other cardiac disease with risk of arterial embolism or with a previous venous thromboembolic event with high risk of recurrence, and receiving chronic oral anticoagulation (OA) with any VKA drug, and whom have been trained in our Unit by specialized nurses on self-management of their OA by using a portable coagulometer to weekly test the International Normalized Ratio (INR)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thromboembolic events	Any documented embolic stroke, peripheral arterial embolism or venous thromboembolism	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	since 1 of july of 2002 to 30th of june of 2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Death from any cause	since 1 of july of 2002 to 30th of june of 2018

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2017
• Primary Completion (ACTUAL): July 30, 2018
• Study Completion (ACTUAL): September 30, 2018

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 20, 2018
• First Posted (ACTUAL): May 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Patient Self-management, Acenocoumarol, Warfarin
• Other Study ID Numbers: IIBSP-ORI-2017-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No