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Trial record 1 of 1 for:    NCT00788736
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Predicting Bleeding Risk on Anticoagulant Therapy for Venous Thromboembolism

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ClinicalTrials.gov Identifier: NCT00788736
Recruitment Status : Completed
First Posted : November 11, 2008
Last Update Posted : October 27, 2016
Sponsor:
Collaborators:
Heart and Stroke Foundation of Ontario
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Tracking Information
First Submitted Date November 10, 2008
First Posted Date November 11, 2008
Last Update Posted Date October 27, 2016
Study Start Date September 2008
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 10, 2008)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00788736 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 10, 2008)
  • 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 ]
  • recurrent venous thromboembolism [ Time Frame: ongoing for 3-7 years with follow-up phone calls at 6-month intervals ]
  • death (all causes) [ Time Frame: ongoing for 3-7 years with follow-up phone calls at 6-month intervals ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predicting Bleeding Risk on Anticoagulant Therapy for Venous Thromboembolism
Official Title Development and Validation of Clinical Prediction Rules for Bleeding for Patients on Anticoagulant Therapy for Venous Thromboembolism
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 or venous thromboembolism (VTE) recurrence for at least 3 months since diagnosis and are being considered for long-term oral anticoagulant therapy.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Subjects may consent to optional DNA and plasma banking
Sampling Method Non-Probability Sample
Study Population Outpatients being treated for venous thromboembolism
Condition Venous Thromboembolism
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 25, 2016)
2537
Original Estimated Enrollment
 (submitted: November 10, 2008)
2450
Actual Study Completion Date October 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00788736
Other Study ID Numbers OHREB 2008270-01H
MOP130388 ( Other Identifier: Canadian Institutes of Health Research (CIHR) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Ottawa Hospital Research Institute
Study Sponsor Ottawa Hospital Research Institute
Collaborators
  • Heart and Stroke Foundation of Ontario
  • Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Phil S Wells, MD, MSc Ottawa Hospital Research Institute
PRS Account Ottawa Hospital Research Institute
Verification Date October 2016