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Sponsors and Collaborators: |
Ottawa Health Research Institute Heart and Stroke Foundation of Ontario |
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Information provided by: | Ottawa Health Research Institute |
ClinicalTrials.gov Identifier: | NCT00788736 |
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 5-8 months since diagnosis and are being considered for long-term oral anticoagulant therapy.
Condition |
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Venous Thromboembolism |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Development and Validation of Clinical Prediction Rules for Bleeding for Patients on Anticoagulant Therapy for Venous Thromboembolism |
Subjects may consent to optional DNA and plasma banking
Estimated Enrollment: | 2450 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2013 |
Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
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 patient 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Outpatients being treated for venous thromboembolism
Inclusion Criteria:
Exclusion Criteria:
Contact: Nicole Langlois, RN, MSc | 613 798-5555 ext 12692 | nlanglois@ohri.ca |
Contact: Nicholas Galambos, MBA | 613 798-5555 ext 19767 | ngalambos@ohri.ca |
Canada, Ontario | |
Ottawa Health Research Institute | Recruiting |
Ottawa, Ontario, Canada, K1Y 4E9 | |
Contact: Nicole Langlois, RN, MSc 613 798-5555 ext 12692 nlanglois@ohri.ca | |
Contact: Nicholas Galambos, MBA 613 798-5555 ext 19767 ngalambos@ohri.ca | |
Principal Investigator: Phil Wells, MD, MSc | |
London Health Sciences Centre | Recruiting |
London, Ontario, Canada, N6A 4G5 | |
Principal Investigator: Michael Kovacs, MD | |
Sub-Investigator: Alejandro Lazo-Langner, MD, MSc | |
St. Joseph's Healthcare Hamilton | Not yet recruiting |
Hamilton, Ontario, Canada, L8N 4A6 | |
Principal Investigator: Crowther Mark, MD | |
Sub-Investigator: James Douketis, MD | |
Sub-Investigator: Wendy Lim, MD | |
Sub-Investigator: Powers Peter, MD | |
Hamilton Health Sciences | Not yet recruiting |
Hamilton, Ontario, Canada, L8V 1C3 | |
Principal Investigator: Clive Kearon, MB, PhD |
Principal Investigator: | Phil S Wells, MD, MSc | Ottawa Health Research Institute |
Responsible Party: | Ottawa Health Research Institute ( Phil Wells ) |
Study ID Numbers: | OHREB 2008270-01H, NA 6415 |
Study First Received: | November 10, 2008 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00788736 |
Health Authority: | Canada: Ethics Review Committee |
venous thromboembolism long-term oral anticoagulant therapy warfarin bleeding risk clinical prediction rule |
predictors deep vein thrombosis pulmonary embolism vitamin k antagonist side effect |
Embolism and Thrombosis Pulmonary Embolism Embolism Vitamin K Vascular Diseases Venous Thrombosis |
Warfarin Hemorrhage Venous Thromboembolism Thromboembolism Thrombosis |
Cardiovascular Diseases |