Overview

This trial is active, not recruiting.

Condition venous thromboembolism
Sponsor Dr. P. Wells
Collaborator Heart and Stroke Foundation of Ontario
Start date September 2008
End date September 2015
Trial size 2450 participants
Trial identifier NCT00788736, MOP130388, OHREB 2008270-01H

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Development and Validation of Clinical Prediction Rules for Bleeding for Patients on Anticoagulant Therapy for Venous Thromboembolism
Principal investigator Phil S Wells, MD, MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Ottawa Hospital Research Institute.