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Search / Trial NCT00788736

Predicting Bleeding Risk on Anticoagulant Therapy for Venous Thromboembolism

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Nov 10, 2008

Trial Information

Current as of July 22, 2025

Completed

Keywords

Venous Thromboembolism Long Term Oral Anticoagulant Therapy Warfarin Bleeding Risk Clinical Prediction Rule Predictors Deep Vein Thrombosis Pulmonary Embolism Vitamin K Antagonist Side Effect

ClinConnect Summary

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 h...

Gender

ALL

Eligibility criteria

  • 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

About Ottawa Hospital Research Institute

The Ottawa Hospital Research Institute (OHRI) is a leading academic research institute dedicated to advancing health and healthcare through innovative research and evidence-based practices. Affiliated with The Ottawa Hospital and the University of Ottawa, OHRI fosters a collaborative environment that brings together clinicians, scientists, and trainees to conduct groundbreaking clinical trials and translational research. With a focus on improving patient outcomes, OHRI specializes in a wide range of fields, including cancer, cardiovascular health, and regenerative medicine. The institute is committed to ethical research practices and the dissemination of knowledge to enhance public health and inform healthcare policy.

Locations

Montreal, Quebec, Canada

Burlington, Massachusetts, United States

London, Ontario, Canada

Detroit, Michigan, United States

Hamilton, Ontario, Canada

Ottawa, Ontario, Canada

Halifax, Nova Scotia, Canada

Montreal, Quebec, Canada

Hamilton, Ontario, Canada

Hamilton, Ontario, Canada

Montreal, Quebec, Canada

Montreal, Quebec, Canada

Oxford, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Phil S Wells, MD, MSc

Principal Investigator

Ottawa Hospital Research Institute

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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