(H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol (FUTURA)
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|ClinicalTrials.gov Identifier: NCT00526058|
Recruitment Status : Completed
First Posted : September 6, 2007
Results First Posted : July 30, 2010
Last Update Posted : July 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypercholesterolemia||Device: Secura Device: Futura Device: Futura Device: Secura||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Multicenter Crossover Study to Compare the Plasmat® Futura Heparin Induced Extracorporeal Lower Density Lipo-Protein (LDL) Precipitation (H.E.L.P.) Apheresis System to the Approved Secura System in the Reduction of LDL-c in Patients With Hypercholesterolemia|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||December 2008|
The Group Randomized first to the approved Plasmat® Secura apheresis system and then to the Plasmat® Futura apheresis system.
Device: Secura Device: Futura
Randomized to 6 bi-monthly H.E.L.P. therapy treatments with the Plasmat® Secura apheresis system and then cross over to receive 6 bi-monthly treatments with the Plasmat® Futura apheresis system.
The Group Randomized first to the approved Plasmat® Futura apheresis system and then to the Plasmat® Secura apheresis system.
Device: Futura Device: Secura
Randomized to 6 bi-monthly H.E L.P. therapy treatments with the Plasmat® Futura apheresis system and then cross over to receive 6 bi-monthly treatments with the Plasmat® Secura apheresis system.
- Percent Change in Pre- and Post-treatment Reductions of Low-density Lipoprotein Cholesterol (LDL-C) Levels Between the Approved H.E.L.P. System and the Modified H.E.L.P. System. [ Time Frame: Blood samples for LDL-cholesterol determination will be obtained before and after each treatment from week 0 to week 24.. ]
- Percent Change of the Pre and Post Treatment Value [ Time Frame: Assessment based on LDL-C values obtained pre-and post-treatment, analyzed from week 0 to week 24. ]The primary study endpoint is the change in percent measurements of the pre-to-post apheresis LDL measurements. Blood samples for LDL-cholesterol determination will be obtained before and after each treatment. The pooled difference between the pre- and post-treatment LDL level for each apheresis machine will be reported as the primary endpoint for the system performance.
- Clinical Lab Profiles [ Time Frame: Analyzed at specific time points throughout the study from week 0 to week 24. ]Blood samples will be obtained for hematology; coagulation, Prothrombin time, , and Inflammatory markers,chemistry (Alkaline phosphatase, blood urea nitrogen, CPK (Creatine phosphokinase, Creatinine, Ferritin, Glucose, Lactate dehydrogenase, Phosphate, and uric acid) and liver functions (Total Protein, Total bilirubin, Alanine Aminotransferase (ALT), Aspartate transaminase (AST); immunoglobulins; complement components; endocrine; and urinalysis (color, specific gravity, wbc (white blood count), rbc (red blood count), urinary dipstick chemistry, and examination of sediment) will be obtained.
- Device Parameters [ Time Frame: Analyzed at specific time points throughout the study from week 0 to week 24. ]
Apheresis Machine Physical parameters; Parameter Description (Abbreviation) Plasmat® Secura Plasma Flow (Plasma Pump) Plasma Pressure 1 (PLP 1) Plasma Pressure 2 (PLP 2) Filtration Pressure 1 (FP 1) Transmembrane Pressure (TMP) Plasmat® Futura Plasma Flow (Plasma Pump) Pressure at Precipitate Filter (PPF) Pressure at Dialysis Filter (PDF) Pressure Drop Across Precipitate Adsorber (PDPA)*
- PDPA = PPF - PDF
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526058
|United States, Connecticut|
|Hartford, Connecticut, United States, 06102|
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Patrick Moriarty, M.D.||University of Kansas Medical Center|
|Principal Investigator:||Paul Thompson, M.D.||Hartford Hospital|