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临床试验/NCT03212053
NCT03212053已完成不适用

Prospective Study of Different Biological Tests (Multiplate, ROTEM) in a Cohort of Patients Followed for Essential Thrombocytemia (ET)

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2017年8月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Occurrence of thrombotic complications

研究概览

简要总结

There is no prospective study published on the Essential Thrombocythemia and the correlation between this specific disease, its complications and the biological variations observed.

The aim of this study is to demonstrate a correlation between biological tests of haemostasis, as Multiplate analyser and thromboelastometry (ROTEM) and the occurrence of clinical complications, thrombosis and/or haemorrhage, in order to determine if this biological tests could be biological prognostic factors

研究设计

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

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

  • Adult aged more than 18 years old
  • Patient followed in consultation for an Essential Thrombocythemia at diagnosis or during the follow-up
  • Collection of the informed consent
  • Patient affiliated to Social Security

排除标准

  • Patients aged less than 18 years old
  • Refusal of signature of the informed consent
  • Patients under guardianship

结局指标

主要结局

Occurrence of thrombotic complications

时间窗: every 4 months, up to 18 months

All thrombotic complications will be gathered by the investigators during the four months following the realization of Multiplate and ROTEM test

Occurrence of haemorrhagic complications

时间窗: every 4 months, up to 18 months

All haemorrhagic complications will be gathered by the investigators during the four months following the realization of Multiplate and ROTEM test

次要结局

  • Occurrence of haemorrhagic complications(every 4 months, up to 18 months)
  • Occurrence of thrombotic complications(every 4 months, up to 18 months)
  • Changes of tests results according to medical treatments(every 4 months, up to 18 months)
  • Description of platelet physiopathology(the day of inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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