Clinical Outcomes From Patient Self-management of Antivitamin K Treatment

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03532724

Acronym

ORION

Enrollment

927

Registered

2018-05-22

Start date

2017-11-01

Completion date

2018-09-30

Last updated

2019-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Self Management of Oral Anticoagulation With VKA Therapy

Keywords

Patient Self-management, Acenocoumarol, Warfarin

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)

Interventions

DEVICEPatient Self-Management of VKA therapy

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Thromboembolic events	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	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

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026