(H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol (FUTURA)

This is an interventional other trial for Hypercholesterolemia focused on measuring Heparin, Extracorporeal, Low Density Lipo-Protein (LDL) Cholesterol, Apheresis, Device Read More

Inclusion Criteria:

• Subject is between 25 and 70 years of age (inclusive) at the time of randomization.
• Subject is an appropriate candidate for H.E.L.P. apheresis treatment for hypercholesterolemia according to current Plasmat® Secura approval criteria.
• Subject has received a minimum of two consecutive bi-monthly* H.E.L.P. apheresis treatments using the Plasmat® Secura apheresis system >30 days prior to the screening visit.
• Subject is willing to maintain cholesterol lowering dietary and drug therapies as prescribed through the course of the study.
• Subject is willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) Waiver.

• Sterile, post-menopausal, or using acceptable birth control for the duration of the study. Acceptable birth control is defined as having a vasectomized, postmenopausal, or sterile partner; the ongoing use of approved hormonal contraceptives, barrier method, or an intrauterine device; or abstinence.

  • Every 14 days (±2 days)

Exclusion Criteria:

• A History of a known sensitivity to heparin or ethylene oxide.
• A history of hemorrhagic diathesis, bleeding/clotting disorder, thrombocytopenia (defined as platelet count < 150 x109/L), or for whom the use of heparin would cause excessive or uncontrolled anticoagulation or for whom adequate anticoagulation cannot be safely achieved (ie., hemophilia, recent surgery, acute internal bleeding, gastrointestinal ulcers).
• Females who are pregnant or lactating.
• Subjects< 106 lbs. or <48.2 kg in body weight; or whose weight is >1.5 times their ideal weight.
• Certain cardiac impairments such as congestive heart failure, major arrhythmia, or diastolic blood pressure greater than 100 mm/Hg on two separate occasions at least 24 hours apart.
• Renal insufficiency defined as creatinine greater >2.0 mg/dlL or is dependent upon renal dialysis.
• Untreated hypothyroidism; uncontrolled diabetes mellitus; or fasting triglycerides >500 mg/dL.
• Serious systemic disease (e.g., advanced neoplasms, and acute hepatitis) including Immune system suppression or compromise, that could preclude survival to study completion.
• History of stroke within 6 months of the screening visit.
• Received thrombolytic treatment < 7 days of screening.visit.
• Taken or requires a prohibited treatment < 30 days prior to the Screening Visit, or requires a prohibited treatment at anytime during the course of the study.
• Neutropenia (neutrophil count < 0.5 x109/L).
• History of liver disease or serum ALT and/or AST > 2X upper limit of normal range.
• History of dementia.
• History of anemia (value outside the lower normal range).
• acetyl salicylic acid (ASA) > 325 mg/day.
• Subject currently enrolled in another investigational study (does not apply to PMS for Secura device).
• Subject with any other medical condition that in the opinion of the investigator might put the subject at risk or interfere with his/her participation.
• Subject is unwilling or unable to comply with the protocol or to cooperate fully with the investigator or site personnel.