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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)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Death from any cause | since 1 of july of 2002 to 30th of june of 2018 |
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Inclusion Criteria:
Exclusion Criteria:
1. Patients younger than 18 years old
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Juan C Souto, MD, PhD | Hospital de la Santa creu i Sant Pau - Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hspital de la Santa Creu i Sant Pau | Barcelona | Catalonia | 08025 | Spain |
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