NCT01753232

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

Non-interventional Study: Safety and Efficacy of the DALI LDL-adsorber and MONET-lipoprotein Filter

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 108 (actual)
• Sponsor: Fresenius Medical Care Deutschland GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Hypercholesterolemia, Familial
• LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA

Interventions

Type	Name	Description
DEVICE	DALI-adsorber	Recording of treatment data. No extra interventional treatment
DEVICE	MONET-Lipoprotein filter	Only treatment data recording. No extra interventional treatment

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-12-01
• Completion: 2015-08-01
• First posted: 2012-12-20
• Last updated: 2015-09-04

Locations

11 sites across 1 country: Germany