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临床试验/NCT02897258
NCT02897258已完成不适用

Thrombosis and Haemorrhage in Chronic Hemodialysis Patients - T2HD

Central Hospital, Nancy, France0 个研究点目标入组 600 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
600
主要终点
Survival without major clinical event

研究概览

简要总结

The study T2HD "Thrombosis and Haemorrhage in chronic hemodialysis patients" is a study of pharmacoepidemiology observational, retrospective cohort, multicenter including 12 dialysis centers for adults Lorraine.

The main objective is to :

Describe the prescribing practices of drugs anticoagulants and antiplatelet agents in chronic hemodialysis patients in the Lorraine region.

The second objective is to :

Study the impact of these practices on the survival and the occurrence of major clinical events, thrombotic and hemorrhagic.

详细描述

All adult patients aged 18 and over who started a new hemodialysis replacement therapy in Lorraine between 01/01/2009 and 31/12/2010 are identified from the registry REIN (Epidemiology and Information Network in nephrology). The latter are included in the study T2HD to the initiation of dialysis and followed until the date point 30/06/2013.

The outcome was survival without major clinical event. Are considered major clinical events: acute coronary syndrome, acute limb ischemia, deep venous thrombosis, arterial thrombosis, pulmonary embolism, thrombosis First, ischemic or hemorrhagic stroke, the digestive hemorrhage, and severe bleeding.

Statistical analysis will compare event-free survival of patients in 4 groups. Patients will be censored at the time of the occurrence of a kidney transplant, a dialysis method of change, a dialysis withdrawal, a move outside Lorraine, or date point if they are still alive . To minimize bias maximum indication, patients of different groups will be matched on propensity score (probability for a given patient to be treated by antiplatelet and / or anticoagulant).

研究设计

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

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

  • Male or female aged 18 and over,
  • In end-stage renal disease,
  • Initiating a first hemodialysis replacement therapy in Lorraine between 01/01/2009 and 31/12/2010.

排除标准

  • Evolutionary Neoplasia at start of dialysis,
  • Death within 45 days of the start of dialysis.

结局指标

主要结局

Survival without major clinical event

时间窗: up to 54 months

In Chronic Hemodialysis Patients

次要结局

未报告次要终点

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

GUILLEMIN Francis, MD

Professor

Central Hospital, Nancy, France

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