Hypercholesterolemia, Familial, LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA
Conditions
Keywords
DALI adsorber, MONET lipoprotein filter
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.
Interventions
DEVICEDALI-adsorber
Recording of treatment data. No extra interventional treatment
DEVICEMONET-Lipoprotein filter
Only treatment data recording. No extra interventional treatment
Sponsors
Fresenius Medical Care Deutschland GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Low Density Lipoprotein (LDL)-Concentration | Every two weeks to every three months for 24 months | Data are only recorded for visits with lab results |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood or plasma flow | Every two weeks to every three months for 24 months | — |
| 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 | Pre/post treatment over 24 months, once per month or every 3 months | Only in patients with isolated Lp(a) increase |
| Change of total cholesterol | Every two weeks to every three months for 24 months | Only for treatment sessions with lab results |
| Change of High Density Lipoprotein (HDL)-concentration | Every two weeks to every three months for 24 months | Only for treatment sessions with lab results |
| Change of triglyceride-concentration | Every two weeks to every three months for 24 months | Only for treatment sessions with lab results |
| Change of blood pressure and heart rate | Every two weeks to every three months for 24 months | Only for treatment sessions with lab results |
| Change of fibrinogen-concentration | Every two weeks to every three months for 24 months | Only for treatment sessions with lab results |
| Change of creatinine-concentration | Every two weeks to every three months for 24 months | — |
| Change of Immunoglobulins (Ig) | Every two weeks to every three months for 24 months | Only for treatment sessions with lab results, Immunoglobulin (Ig) G, IgA and IgM if measured. In MONET patients only. |
| Change in C Reactive Protein (CRP)-concentration | Every two weeks to every three months for 24 months | Only for treatment sessions with lab results |
| 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 | — |
| Change in blood count | Every two weeks to every three months for 24 months | Only for treatment sessions with lab results |
Countries
Germany
Outcome results
None listed