Non-interventional Study: Safety and Efficacy of the DALI LDL-adsorber and MONET-lipoprotein Filter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 11
- 主要终点
- Change of Low Density Lipoprotein (LDL)-Concentration
研究概览
简要总结
Low Density Lipoprotein (LDL)-apheresis refers to a procedure in which blood taken from a patient's vein is cleaned from pathogenic substances, e.g. cholesterol, outside the body and then given back to the patient. In the DALI (Direct Adsorption of Lipoproteins)-system whole blood is pumped over an adsorber containing beads that selectively bind LDL-cholesterol. The MONET (Membrane filtration Optimized Novel Extracorporeal Treatment)-system works with plasma which is cleaned by filtration. This study comprises the recording of safety and efficacy data from patients treated either with the DALI or MONET-system over a period of 2 years.
详细描述
Data were recorded from patients suffering from familial hypercholesterolemia and treated by lipid apheresis using one of the two systems investigated for at least 3 months prior to inclusion in the study. Only those treatments were documented in which routine blood samples for laboratory analysis were taken, or in which adverse or serious adverse device effects occur.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •given informed consent
- •18 years or older
- •patient compliant to therapy as prescribed
- •at least two therapy sessions per month
- •treatment with DALI or MONET system for at least 3 months before inclusion
- •last severe invasive intervention in hospital more than 3 months ago
排除标准
- •earlier participation in the study
- •unconscious patient/persons without capacity to contract
- •for DALI: intake of ACE-inhibitors
结局指标
主要结局
Change of Low Density Lipoprotein (LDL)-Concentration
时间窗: Every two weeks to every three months for 24 months
Data are only recorded for visits with lab results
次要结局
- Blood/plasma volume treated(Every two weeks to every three months for 24 months)
- Number of occurence of adverse and serious adverse device effects(24 months)
- Change of Lipoprotein(a)-concentration(Pre/post treatment over 24 months, once per month or every 3 months)
- Change of High Density Lipoprotein (HDL)-concentration(Every two weeks to every three months for 24 months)
- Change of triglyceride-concentration(Every two weeks to every three months for 24 months)
- Change in blood count(Every two weeks to every three months for 24 months)
- Change of blood pressure and heart rate(Every two weeks to every three months for 24 months)
- Blood or plasma flow(Every two weeks to every three months for 24 months)
- Change of total cholesterol(Every two weeks to every three months for 24 months)
- Change of creatinine-concentration(Every two weeks to every three months for 24 months)
- Anticoagulation regime(Every two weeks to every three months for 24 months)
- Treatment time(Every two weeks to every three months for 24 months)
- Medication(Every two weeks to every three months for 24 months)
- Change of Immunoglobulins (Ig)(Every two weeks to every three months for 24 months)
- Change in C Reactive Protein (CRP)-concentration(Every two weeks to every three months for 24 months)
- Change of fibrinogen-concentration(Every two weeks to every three months for 24 months)