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Predicting Bleeding Risk on Anticoagulant Therapy for Venous Thromboembolism

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Heart and Stroke Foundation of Ontario
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. P. Wells, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00788736
First received: November 10, 2008
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition
Venous Thromboembolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development and Validation of Clinical Prediction Rules for Bleeding for Patients on Anticoagulant Therapy for Venous Thromboembolism

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Major bleeding (International Society on Thrombosis and Haemostasis(ISTH) criteria) [ Time Frame: ongoing for 3-7 years with follow-up phone calls at 6-month intervals ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinically relevant non-major bleeding (International Society on Thrombosis and Haemostasis(ISTH) criteria) [ Time Frame: ongoing for 3-7 years with follow-up phone calls at 6-month intervals ] [ Designated as safety issue: Yes ]
  • recurrent venous thromboembolism [ Time Frame: ongoing for 3-7 years with follow-up phone calls at 6-month intervals ] [ Designated as safety issue: Yes ]
  • death (all causes) [ Time Frame: ongoing for 3-7 years with follow-up phone calls at 6-month intervals ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Subjects may consent to optional DNA and plasma banking


Estimated Enrollment: 2450
Study Start Date: September 2008
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatients being treated for venous thromboembolism

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788736

Locations
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, MA01805
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 1C3
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Hopital du Sacre Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
St. Mary's Hospital Centre
Montreal, Quebec, Canada, H3T 1M5
United Kingdom
Oxford Haemophilia and Thrombosis Centre, Churchill Hospital
Oxford, United Kingdom, 0X3 7LJ
Sponsors and Collaborators
Dr. P. Wells
Heart and Stroke Foundation of Ontario
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Phil S Wells, MD, MSc Ottawa Hospital Research Institute
  More Information

No publications provided

Responsible Party: Dr. P. Wells, MD, M.Sc.,Chair Department of Medicine, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00788736     History of Changes
Other Study ID Numbers: OHREB 2008270-01H, MOP130388
Study First Received: November 10, 2008
Last Updated: July 29, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
venous thromboembolism
long-term oral anticoagulant therapy
warfarin
bleeding risk
clinical prediction rule
predictors
deep vein thrombosis
pulmonary embolism
vitamin k antagonist
side effect

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014