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临床试验/NCT04297085
NCT04297085招募中不适用

Prospective Cohort Study on the Determinants of Venous THromboembolic Recurrence. BREIZH-Cohorte

University Hospital, Brest4 个研究点 分布在 1 个国家目标入组 3,400 人开始时间: 2020年5月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
3,400
试验地点
4
主要终点
Recurrence of thromboembolic venous disease

研究概览

简要总结

The main objective of the BREIZH-Cohorte study is to determine the incidence of recurrent short, medium and long-term thromboembolic venous disease as well as risk factors for recurrence in two specific populations: patients under 50 years of age, men and women (5 year recurrence), as well as cancer patients (all ages) (1 year recurrence).

详细描述

Deep vein thrombosis (DVT) and pulmonary embolism (PE) are two clinical manifestations of the same entity, thromboembolic venous disease. This disease is frequent: the annual incidence of thromboembolic venous disease estimated between 1 and 2 cases per 1000 inhabitants per year in France, comparable to that observed in North America. This disease is potentially serious: the mortality from PE, the most severe manifestation of thromboembolic venous disease (one third of PE for two thirds of DVT) is 10% at 3 months, twice as high as that of myocardial infarction. However, the risk of PE in isolated DVT is major (more than 50% of cases). Thus, whether it is a PE or a DVT, anticoagulant treatment, a cornerstone of therapeutic management, must therefore be initiated urgently, without waiting for the results of diagnostic confirmatory examinations.

The major complications occurring after a thromboembolic venous disease are venous thromboembolic recurrence (VTE) and the long-term consequences: post-thrombotic syndrome and the development of post-embolic pulmonary hypertension. VTE recurrence has significant mortality, particularly in the form of PE (15%, compared to 2% in the form of DVT). As for long-term complications of VTE, about 20-30% of patients with DVT develop post-thrombotic syndrome at 5 years (27), while 0.15% to 5% of patients with PE develop post-embolic pulmonary hypertension at 1 year.

While major progress has been made over the past 20 years in terms of diagnosis, primary and secondary prevention, identification of risk factors for VTE and prognostic factors, however, two particular subgroups deserve to be specifically investigated: young subjects, whether women (hormonal exposure) or men (often idiopathic thromboembolic venous disease), and cancer patients. In the latter, the progress made on anti-cancer treatments is helping to modify the data on the risk of VTE as well as the duration of treatment of VTE in these patients.

Thus, this prospective cohort covers two subgroups of patients with thromboembolic venous disease: young subjects (≤50 years) or those who have cancer.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Subject aged 18 or over, or a minor with the consent of the parents and the minor, presenting with a thromboembolic venous disease
  • 50 and under or any age if active cancer
  • Affiliated to social security
  • Accepting to participate in the study.

排除标准

  • Inability to communicate (comprehension disorder).
  • Refusal to participate.

研究组 & 干预措施

Cases

Experimental

干预措施: Biologic sample (Biological)

结局指标

主要结局

Recurrence of thromboembolic venous disease

时间窗: 20 years

Recurrence of thromboembolic venous disease will be established at the end of patient monitoring

次要结局

  • Haemorrhages under anticoagulant(20 years)
  • Mortality(20 years)
  • Arterial complications(20 years)
  • Long-term complications(20 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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