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临床试验/NCT02188056
NCT02188056已完成不适用

Observational Prospectif Monocentric Registry of Patients Suffering From VIE

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
incidence of recurrent thromboembolic

研究概览

简要总结

Patients with an episode of VTE (DVT and / or PE) have a mortality rate of 16-21% at 1 year after diagnosis. Morbidity associated with VTE is marked by the risk of recurrence, estimated at 30% and estimated at 29% after 8 years of follow post-thrombotic syndrome. For a number of these patients, risk factors have been identified (congenital or acquired thrombophilia, cancer, postpartum, surgery, prolonged immobilization, etc..). In 25-50% of cases, the etiology remains unknown, justifying the need for well-conducted studies to determine other potential risk factors. In addition, the expansion of treatment options with the arrival on the market of new direct oral anticoagulants, allows comparative studies on the effectiveness and frequency of adverse events for each treatment.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • diagnosis of venous thromboembolism established by a validated test (venous Doppler ultrasound of the lower limbs, pulmonary angiography, lung scan ventilation / perfusion),
  • diagnosis of venous thromboembolism made within 15 days,
  • the previous inclusion in the register (outpatient or inpatient)

排除标准

  • person doesn't wish to participate in this study

结局指标

主要结局

incidence of recurrent thromboembolic

时间窗: at 1 year post-diagnosis

bleeding complications incidence

时间窗: at 1 year post-diagnosis

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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