Clinical trial NCT01753232: Safety and Efficacy of the DALI LDL-adsorber and MONET Lipoprotein Filter
Official title: Non-interventional Study: Safety and Efficacy of the DALI LDL-adsorber and MONET-lipoprotein Filter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia, Familial
LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA
Keywords: DALI adsorber
MONET lipoprotein filter
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
First posted: 2012-12-20
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypercholesterolemic patients from free-standing private apheresis centres and one hospital department

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Low Density Lipoprotein (LDL)-Concentration
timeFrame: Every two weeks to every three months for 24 months
Secondary outcomes:
measure: Blood/plasma volume treated
timeFrame: Every two weeks to every three months for 24 months
measure: Number of occurence of adverse and serious adverse device effects
timeFrame: 24 months
measure: Change of Lipoprotein(a)-concentration
timeFrame: Pre/post treatment over 24 months, once per month or every 3 months
measure: Change of total cholesterol
timeFrame: Every two weeks to every three months for 24 months
measure: Change of High Density Lipoprotein (HDL)-concentration
timeFrame: Every two weeks to every three months for 24 months
measure: Change of triglyceride-concentration
timeFrame: Every two weeks to every three months for 24 months
measure: Change in blood count
timeFrame: Every two weeks to every three months for 24 months
measure: Change of fibrinogen-concentration
timeFrame: Every two weeks to every three months for 24 months
measure: Change of creatinine-concentration
timeFrame: Every two weeks to every three months for 24 months
measure: Change of Immunoglobulins (Ig)
timeFrame: Every two weeks to every three months for 24 months
measure: Change in C Reactive Protein (CRP)-concentration
timeFrame: Every two weeks to every three months for 24 months
measure: Change of blood pressure and heart rate
timeFrame: Every two weeks to every three months for 24 months
measure: Blood or plasma flow
timeFrame: Every two weeks to every three months for 24 months
measure: Anticoagulation regime
timeFrame: Every two weeks to every three months for 24 months
measure: Treatment time
timeFrame: Every two weeks to every three months for 24 months
measure: Medication
timeFrame: Every two weeks to every three months for 24 months
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Nierenzentrum Mannheim
state: Baden Würtemberg
city: Kempten
country: Germany
facility: Medizinisches Versorgungszentrum
state: Bayern
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg Institut für Klinische Chemie und Laboratoriumsmedizin
state: Bayern
city: Potsdam
country: Germany
facility: Dialysezentrum Potsdam
state: Brandenburg
city: Rostock
country: Germany
facility: Apheresezentrum Rostock
state: Mecklenburg-Vorpommern
city: Goettingen
country: Germany
facility: Nephrologisches Zentrum Goettingen
state: Niedersachsen
city: Hannover
country: Germany
facility: Zentrum für Nieren und Hochdruckkrankheiten Standort Heidering
state: Niedersachsen
city: Essen
country: Germany
facility: Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum
state: Nordrhein Westfalen
city: Köln
country: Germany
facility: Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann
state: Nordrhein-Westfalen
city: Ingelheim
country: Germany
facility: Apheresezentrum Ingelheim
state: Rheinland Pfalz
city: Magdeburg
country: Germany
facility: Dialysezentrum Magdeburg-Stattfeld
state: Sachsen Anhalt
Study officials:
affiliation: Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann
name: Rainer Heinzler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dres. Heigl, Hettich & Partner Medizinisches Versorgungszentrum
name: Franz Heigl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nierenzentrum Mannheim
name: Frank Leistikow, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Apheresezentrum Ingelheim
name: Frido Himmelsbach, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum
name: Ralf Spitthöver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zentrum für Nieren,- Hochdruck und Stoffwechselerkrankungen Standort Heidering
name: Eberhard Roeseler, MD, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Nephrologisches Zentrum Goettingen
name: Volker Schettler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Regensburg Department Clinical Chemistry and Laboratory Medicine
name: Gerd Schmitz, MD, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Dialysezentrum Magdeburg-Stadtfeld
name: Nadim Abduhl-Rahman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dialysezentrum Potsdam
name: Jens Ringel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Apheresezentrum Rostock
name: Wolfgang Ramlow, MD
role: PRINCIPAL_INVESTIGATOR
References: