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临床试验/NCT00788736
NCT00788736已完成不适用

Development and Validation of Clinical Prediction Rules for Bleeding for Patients on Anticoagulant Therapy for Venous Thromboembolism

Ottawa Hospital Research Institute12 个研究点 分布在 3 个国家目标入组 2,537 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,537
试验地点
12
主要终点
Major bleeding (International Society on Thrombosis and Haemostasis(ISTH) criteria)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >=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)

排除标准

  • 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

结局指标

主要结局

Major bleeding (International Society on Thrombosis and Haemostasis(ISTH) criteria)

时间窗: ongoing for 3-7 years with follow-up phone calls at 6-month intervals

次要结局

  • death (all causes)(ongoing for 3-7 years with follow-up phone calls at 6-month intervals)
  • Clinically relevant non-major bleeding (International Society on Thrombosis and Haemostasis(ISTH) criteria)(ongoing for 3-7 years with follow-up phone calls at 6-month intervals)
  • recurrent venous thromboembolism(ongoing for 3-7 years with follow-up phone calls at 6-month intervals)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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