Predicting Bleeding Risk on Anticoagulant Therapy for Venous Thromboembolism

Study Overview
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Brief Summary
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The main objective of the study is to develop or validate a clinical prediction rule for major bleeding in patients on oral anticoagulant therapy who have been safely anticoagulated without bleeding or venous thromboembolism (VTE) recurrence for at least 3 months since diagnosis and are being considered for long-term oral anticoagulant therapy.

Detailed Description
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Oral anticoagulant therapy for patients who are at risk of developing blood clotting problems is used by between 400,000-600,000 Canadians annually. The use of this drug represents the most common cause of patient adverse medical outcomes due to medical errors. Furthermore, many patients have adverse outcomes using these drugs because physicians are not able to predict which patients are likely to have bleeding outcomes. Much effort has gone into developing ways to predict which patients are at risk of clotting but almost no work has gone into ways of predicting which patients would be at high risk of bleeding. This information is required to balance off the risk-benefits and to enable physicians and patients to understand the risks and benefits of taking these medications. Our study will develop a tool that can be used to predict bleeding risk in patients taking oral anticoagulant therapy. It will enable more informed decision making by both physicians and patients and will result in better control of the use of these drugs. In addition, patients who are at risk for being difficult to accurately dose on oral anticoagulants will be identified through our study.

Official Title
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Development and Validation of Clinical Prediction Rules for Bleeding for Patients on Anticoagulant Therapy for Venous Thromboembolism

Conditions
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Venous Thromboembolism

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >=18 years old provoked or unprovoked venous thromboembolism objectively confirmed venous thromboembolism treated with an oral anticoagulant(vitamin K antagonist or new oral anticoagulant) for at least 3 months with plans to continue long-term if taking a vitamin K antagonist; INR target is between 2.0-3.0 if taking a vitamin K antagonist; must have taken it for the last 3 consecutive weeks (minimum) Exclusion Criteria: major bleeding while taking oral anticoagulants active bleeding at study enrollment active cancer - current or at the time of VTE diagnosis unable to provide written informed consent refusal to provide written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding (International Society on Thrombosis and Haemostasis(ISTH) criteria) |  | ongoing for 3-7 years with follow-up phone calls at 6-month intervals | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically relevant non-major bleeding (International Society on Thrombosis and Haemostasis(ISTH) criteria) |  | ongoing for 3-7 years with follow-up phone calls at 6-month intervals | 
| recurrent venous thromboembolism |  | ongoing for 3-7 years with follow-up phone calls at 6-month intervals | 
| death (all causes) |  | ongoing for 3-7 years with follow-up phone calls at 6-month intervals | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venous thromboembolism, long-term oral anticoagulant therapy, warfarin, bleeding risk, clinical prediction rule, predictors, deep vein thrombosis, pulmonary embolism, vitamin k antagonist, side effect