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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Device: DALI-adsorber
* Device: MONET-Lipoprotein filter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DALI-adsorber, hypercholesterolemia<br>Patients suffering from familial hypercholesterolemia treated at least twice a month with the DALI-system | Device: DALI-adsorber<br>* Recording of treatment data. No extra interventional treatment<br>|
| MONET-Filter, hypercholesterolemia<br>Patients suffering from familial hypercholesterolemia treated with the MONET-Lipoprotein filter | Device: MONET-Lipoprotein filter<br>* Only treatment data recording. No extra interventional treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DALI adsorber, MONET lipoprotein filter