Safety and Efficacy of the DALI LDL-adsorber and MONET Lipoprotein Filter (LINET)

Fresenius Medical Care (FMC)

Status: Completed

Conditions: Hypercholesterolemia, Familial; LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA

Treatments: Device: MONET-Lipoprotein filter; Device: DALI-adsorber

Study type: Observational

Funder types: Industry

Identifiers

NCT01753232

TA-DALI-MONET-01-D

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• earlier participation in the study
• unconscious patient/persons without capacity to contract
• for DALI: intake of ACE-inhibitors

Trial design

108 participants in 2 patient groups

DALI-adsorber, hypercholesterolemia

Description:

Patients suffering from familial hypercholesterolemia treated at least twice a month with the DALI-system

Treatment:

Device: DALI-adsorber

MONET-Filter, hypercholesterolemia

Description:

Patients suffering from familial hypercholesterolemia treated with the MONET-Lipoprotein filter

Treatment:

Device: MONET-Lipoprotein filter