Clinical Outcomes From Patient Self-management of Antivitamin K Treatment

Self Management of Oral Anticoagulation With VKA Therapy Clinical Trial

— ORION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03532724
• Other study ID #: IIBSP-ORI-2017-45
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: February 2019
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 927
• Est. completion date: September 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Self Management of Oral Anticoagulation With VKA Therapy

Intervention

Device:
• Patient Self-Management of VKA therapy
Trained patients check weekly the INR using a portable coagulometer an decide by themselves the dosis of VKA

Locations

Country	Name	City	State
Spain	Hspital de la Santa Creu i Sant Pau	Barcelona	Catalonia

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thromboembolic events	Any documented embolic stroke, peripheral arterial embolism or venous thromboembolism	since 1 of july of 2002 to 30th of june of 2018
Primary	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	Mortality	Death from any cause	since 1 of july of 2002 to 30th of june of 2018