Status:
COMPLETED
Predicting Bleeding Risk on Anticoagulant Therapy for Venous Thromboembolism
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Heart and Stroke Foundation of Ontario
Canadian Institutes of Health Research (CIHR)
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
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 o...
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 cau...
Eligibility Criteria
Inclusion
- \>=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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
2537 Patients enrolled
Trial Details
Trial ID
NCT00788736
Start Date
September 1 2008
End Date
October 1 2016
Last Update
October 27 2016
Active Locations (12)
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1
Lahey Clinic
Burlington, Massachusetts, United States, MA01805
2
Henry Ford Health System
Detroit, Michigan, United States, 48202
3
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
4
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2