Performance Evaluation of plasma fraction filter FRACTIOsmart L in comparison to the Cascadeflo EC 50 in regular lipoprotein apheresis setting
- Conditions
- Hypercholesteremia
- Registration Number
- DRKS00025297
- Lead Sponsor
- Kaneka Pharma Europe NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 6
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
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of high (mean value) of the relative reduction of serum concentration by apheresis with 1,1 x plasma volume treatment (before and after tretment values) in both groups
- Secondary Outcome Measures
Name Time Method Reduction of Lp(a) and HDL, influence of LDL apheresis to IgG and IgM, evaluation of safety and compatibility, problems during use, capacity of plasma fraction filter, changes of High Density Lipoprotein (HDL) / Low Density Lipoprotein (LDL) ratio