Performance Evaluation of plasma fraction filter FRACTIOsmart L in comparison to the Cascadeflo EC 50 in regular lipoprotein apheresis setting

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025297

Enrollment

Registered

2021-05-28

Start date

2021-05-20

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesteremia

Interventions

Group 1: Group 1: Therapy 4 x A and 4 x B 3 patients: sequential use of filter A followed by filter B (for each filter 4 consecutive tratments, 4 weeks) Group 2: Therapy 4 x B and 4 x A 3 patients: se

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: - 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, 40, < 50 - Min. since 3 month weekly LDL apheresis treatment - Effective contraception for women of childbearing age

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Germany

Contacts

Public ContactUwe H. Wallstab

Ing. Büro für Medizintechnik

uhw@wallstab.com02206 86 98 14 ; 0171 4317296

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026