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临床试验/NCT07390604
NCT07390604已完成不适用

Case Series : Management of Elevated Lipoprotein(a) Using Double-Filtration Plasmapheresis (DFPP) in Hemodialysis Patients With Chronic Kidney Disease Clinical and Biological Outcomes in Patients at Cardiovascular and Thromboembolic Risk

Centre Hospitalier Régional Metz-Thionville1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
5
试验地点
1
主要终点
serum Lp(a) concentration (nmol/L), on routine venous blood sampling

研究概览

简要总结

Lipoprotein-apheresis DFPP has been performed in patients with Lp(a) levels greater than 125 nmol/L. In this report, data will be presented on five hemodialysis patients with significantly elevated Lp(a) levels (>200 nmol/L) who had a history of cardiovascular disease and notable thromboembolic events.

详细描述

The biological and clinical outcomes related to Lipoprotein-apheresis DFPP treatment and the associated cardiovascular and thromboembolic events will be described in these patients. Additionally, the impact of DFPP on biological and clinical markers including LDL cholesterol, triglycerides, fibrinogen, hemoglobin, platelet count, C-reactive protein (CRP), blood pressure, plasma volume treated, volume of albumin substitution, volume of plasma rejected, and duration of each Lipoprotein-apheresis DFPP session will be evaluated .

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Chronic hemodialysis patients with elevated Lp(a) levels (>200 nmol/L) and a history of cardiovascular disease and/or thromboembolic events who underwent DFPP sessions as part of their management

排除标准

  • -Patients with progressive, active disease, presenting with severe general deterioration and a limited life expectancy
  • Patients presenting with hemodynamic instability
  • Patients presenting with acute kidney diseases.

结局指标

主要结局

serum Lp(a) concentration (nmol/L), on routine venous blood sampling

时间窗: up to 15 months after inclusion

Before and after each DFPP session (repeated measures) during the study period

次要结局

  • serum LDL and serum triglycerides concentration (g/L), on routine venous blood sampling(up to 15 months after inclusion)
  • serum triglycerides concentration (g/L), on routine venous blood sampling(up to 15 months after inclusion)
  • cardiovascular or thromboembolic events(during all the study period: up to 15 months after inclusion)
  • Hemodynamic status:blood pressure(up to 15 months after inclusion)
  • Hemodynamic status: ultrafiltration rate(up to 15 months after inclusion)

研究者

发起方
Centre Hospitalier Régional Metz-Thionville
申办方类型
Other
责任方
Sponsor

研究点 (1)

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