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

Fresenius Medical Care Deutschland GmbH108 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

108

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Nierenzentrum Mannheim

Mannheim, Baden Würtemberg, Germany

Medizinisches Versorgungszentrum

Kempten (Allgäu), Bavaria, Germany

Universitätsklinikum Regensburg Institut für Klinische Chemie und Laboratoriumsmedizin

Regensburg, Bavaria, Germany

Dialysezentrum Potsdam

Potsdam, Brandenburg, Germany

Nephrologisches Zentrum Goettingen

Göttingen, Lower Saxony, Germany

Zentrum für Nieren und Hochdruckkrankheiten Standort Heidering

Hanover, Lower Saxony, Germany

Apheresezentrum Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann

Cologne, North Rhine-Westphalia, Germany

Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum

Essen, North Rhine-Westphalia, Germany

Apheresezentrum Ingelheim

Ingelheim, Rhineland-Palatinate, Germany

...and 1 more locations

Outcomes

Primary Outcomes

Change of Low Density Lipoprotein (LDL)-Concentration

Data are only recorded for visits with lab results

Time frame: Every two weeks to every three months for 24 months

Secondary Outcomes

Blood/plasma volume treated

Time frame: Every two weeks to every three months for 24 months

Number of occurence of adverse and serious adverse device effects

Time frame: 24 months

Change of Lipoprotein(a)-concentration

Only in patients with isolated Lp(a) increase

Time frame: Pre/post treatment over 24 months, once per month or every 3 months

Change of total cholesterol

Only for treatment sessions with lab results

Time frame: Every two weeks to every three months for 24 months

Change of High Density Lipoprotein (HDL)-concentration

Only for treatment sessions with lab results

Time frame: Every two weeks to every three months for 24 months

Change of triglyceride-concentration

Only for treatment sessions with lab results

Time frame: Every two weeks to every three months for 24 months

Change in blood count

Only for treatment sessions with lab results

Time frame: Every two weeks to every three months for 24 months

Change of fibrinogen-concentration

Only for treatment sessions with lab results

Time frame: Every two weeks to every three months for 24 months

Change of creatinine-concentration

Time frame: Every two weeks to every three months for 24 months

Change of Immunoglobulins (Ig)

Only for treatment sessions with lab results, Immunoglobulin (Ig) G, IgA and IgM if measured. In MONET patients only.

Time frame: Every two weeks to every three months for 24 months

Change in C Reactive Protein (CRP)-concentration

Only for treatment sessions with lab results

Time frame: Every two weeks to every three months for 24 months

Change of blood pressure and heart rate

Only for treatment sessions with lab results

Time frame: Every two weeks to every three months for 24 months

Blood or plasma flow

Time frame: Every two weeks to every three months for 24 months

Anticoagulation regime

Time frame: Every two weeks to every three months for 24 months

Treatment time

Time frame: Every two weeks to every three months for 24 months

Medication

Time frame: Every two weeks to every three months for 24 months