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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DALI-adsorber, hypercholesterolemia | Patients suffering from familial hypercholesterolemia treated at least twice a month with the DALI-system |
| |
| MONET-Filter, hypercholesterolemia | Patients suffering from familial hypercholesterolemia treated with the MONET-Lipoprotein filter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DALI-adsorber | Device | Recording of treatment data. No extra interventional treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Low Density Lipoprotein (LDL)-Concentration | Data are only recorded for visits with lab results | Every two weeks to every three months for 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood/plasma volume treated | Every two weeks to every three months for 24 months | |
| Number of occurence of adverse and serious adverse device effects | 24 months | |
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Inclusion Criteria:
Exclusion Criteria:
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Hypercholesterolemic patients from free-standing private apheresis centres and one hospital department
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| Name | Affiliation | Role |
|---|---|---|
| Rainer Heinzler, MD | Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann | Principal Investigator |
| Franz Heigl, MD | Dres. Heigl, Hettich & Partner Medizinisches Versorgungszentrum | Principal Investigator |
| Frank Leistikow, MD | Nierenzentrum Mannheim | Principal Investigator |
| Frido Himmelsbach, MD | Apheresezentrum Ingelheim | Principal Investigator |
| Ralf Spitthöver, MD | Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum | Principal Investigator |
| Eberhard Roeseler, MD, Prof | Zentrum für Nieren,- Hochdruck und Stoffwechselerkrankungen Standort Heidering | Principal Investigator |
| Volker Schettler, MD | Nephrologisches Zentrum Goettingen | Principal Investigator |
| Gerd Schmitz, MD, Prof | University Regensburg Department Clinical Chemistry and Laboratory Medicine | Principal Investigator |
| Nadim Abduhl-Rahman, MD | Dialysezentrum Magdeburg-Stadtfeld |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nierenzentrum Mannheim | Mannheim | Baden Würtemberg | 68309 | Germany | ||
| Medizinisches Versorgungszentrum |
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| MONET-Lipoprotein filter | Device | Only treatment data recording. No extra interventional treatment |
|
| Change of Lipoprotein(a)-concentration |
Only in patients with isolated Lp(a) increase |
| Pre/post treatment over 24 months, once per month or every 3 months |
| Change of total cholesterol | Only for treatment sessions with lab results | Every two weeks to every three months for 24 months |
| Change of High Density Lipoprotein (HDL)-concentration | Only for treatment sessions with lab results | Every two weeks to every three months for 24 months |
| Change of triglyceride-concentration | Only for treatment sessions with lab results | Every two weeks to every three months for 24 months |
| Change in blood count | Only for treatment sessions with lab results | Every two weeks to every three months for 24 months |
| Change of fibrinogen-concentration | Only for treatment sessions with lab results | Every two weeks to every three months for 24 months |
| Change of creatinine-concentration | 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. | Every two weeks to every three months for 24 months |
| Change in C Reactive Protein (CRP)-concentration | Only for treatment sessions with lab results | Every two weeks to every three months for 24 months |
| Change of blood pressure and heart rate | Only for treatment sessions with lab results | Every two weeks to every three months for 24 months |
| Blood or plasma flow | Every two weeks to every three months for 24 months |
| Anticoagulation regime | Every two weeks to every three months for 24 months |
| Treatment time | Every two weeks to every three months for 24 months |
| Medication | Every two weeks to every three months for 24 months |
| Principal Investigator |
| Jens Ringel, MD | Dialysezentrum Potsdam | Principal Investigator |
| Wolfgang Ramlow, MD | Apheresezentrum Rostock | Principal Investigator |
| Kempten (Allgäu) |
| Bavaria |
| 87439 |
| Germany |
| Universitätsklinikum Regensburg Institut für Klinische Chemie und Laboratoriumsmedizin | Regensburg | Bavaria | 93053 | Germany |
| Dialysezentrum Potsdam | Potsdam | Brandenburg | 14482 | Germany |
| Nephrologisches Zentrum Goettingen | Göttingen | Lower Saxony | 37075 | Germany |
| Zentrum für Nieren und Hochdruckkrankheiten Standort Heidering | Hanover | Lower Saxony | 30625 | Germany |
| Apheresezentrum Rostock | Rostock | Mecklenburg-Vorpommern | 18059 | Germany |
| Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann | Cologne | North Rhine-Westphalia | 51105 | Germany |
| Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum | Essen | North Rhine-Westphalia | 45127 | Germany |
| Apheresezentrum Ingelheim | Ingelheim | Rhineland-Palatinate | 55218 | Germany |
| Dialysezentrum Magdeburg-Stattfeld | Magdeburg | Saxony-Anhalt | 39108 | Germany |
| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| C563617 | Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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