Predicting Bleeding Risk on Anticoagulant Therapy for Venous Thromboembolism
- Conditions
- Venous Thromboembolism
- Registration Number
- NCT00788736
- Lead Sponsor
- Ottawa Hospital Research Institute
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2537
- >=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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (12)
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
Sir Mortimer B Davis Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Ottawa Hospital Research Institute
🇨🇦Ottawa, Ontario, Canada
Montreal General Hospital
🇨🇦Montreal, Quebec, Canada
St. Mary's Hospital Centre
🇨🇦Montreal, Quebec, Canada
Hopital du Sacre Coeur de Montreal
🇨🇦Montreal, Quebec, Canada
Oxford Haemophilia and Thrombosis Centre, Churchill Hospital
🇬🇧Oxford, United Kingdom
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada