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Predicting Bleeding Risk on Anticoagulant Therapy for Venous Thromboembolism

NCT ID: NCT00788736

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2537 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2016-10-31

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.

Conditions

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Venous Thromboembolism

Keywords

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Stroke Foundation of Ontario

OTHER

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Phil S Wells, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

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Lahey Clinic

Burlington, Massachusetts, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status

Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

London Health Sciences Centre

London, Ontario, Canada

Site Status

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Site Status

Montreal General Hospital

Montreal, Quebec, Canada

Site Status

Sir Mortimer B Davis Jewish General Hospital

Montreal, Quebec, Canada

Site Status

St. Mary's Hospital Centre

Montreal, Quebec, Canada

Site Status

Hopital du Sacre Coeur de Montreal

Montreal, Quebec, Canada

Site Status

Oxford Haemophilia and Thrombosis Centre, Churchill Hospital

Oxford, , United Kingdom

Site Status

Countries

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United States Canada United Kingdom

Other Identifiers

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MOP130388

Identifier Type: OTHER

Identifier Source: secondary_id

OHREB 2008270-01H

Identifier Type: -

Identifier Source: org_study_id