Predicting Bleeding Risk on Anticoagulant Therapy for Venous Thromboembolism

Completed

Conditions studied: Venous Thromboembolism

In brief

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.

Key facts

Study ID

NCT00788736

Run by

Ottawa Hospital Research Institute

People needed

2537

Starts

2008-09-01

Expected to finish

2016-10-01

Last updated by the study team

2016-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >=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)

You may not qualify if…

• 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

Where it is running

• Lahey Clinic — Burlington, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia, Canada
• Hamilton General Hospital — Hamilton, Ontario, Canada
• Hamilton Health Sciences — Hamilton, Ontario, Canada
• London Health Sciences Centre — London, Ontario, Canada
• Ottawa Hospital Research Institute — Ottawa, Ontario, Canada
• Montreal General Hospital — Montreal, Quebec, Canada
• Sir Mortimer B Davis Jewish 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.