DRKS00025297已完成未知
Performance Evaluation of plasma fraction filter FRACTIOsmart L in comparison to the Cascadeflo EC 50 in regular lipoprotein apheresis setting
Kaneka Pharma Europe NV0 个研究点目标入组 6 人开始时间: 2021年5月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Min. 18 years, max. 70 years (male and female)
- •- Consent of patient
- •- Indication for LDL-apheresis according to the directive of the Bundesausschusses zu Untersuchungs- und Behandlungsmethoden der vertragsärztlichen Versorgung (Richtlinie Methoden vertragsärztliche Versorgung), Anlage I, 1 Ambulante Durchführung der Apheresen als extrakorporales Hämotherapieverfahren (BAnz AT 14.04.2020 B5)
- •- Body weight > 60 kg, < 100 kg
- •- Hkt > 40, < 50
- •- Min. since 3 month weekly LDL apheresis treatment
- •- Effective contraception for women of childbearing age
排除标准
- •- Patients unable to consent according MPG § 20 clause 2 sentence 1 nr. 1
- •- Pregnant and breastfeeding women’s and those that will become pregnant
- •- Participation at another study during the last month
- •- Patients with known or expected allergic reaction against the study product and other products
- •- Scheduled absence during the study duration for the patient of the 8-weeks (for example schedule hospitalization, holidays, …)
- •- Known tumor disease
- •- Patients with antihypertensive therapy via ACE inhibitor, because of higher risk for Bradykinin induced anaphylactic shock
研究者
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