Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy - Full Text View

Sponsor:	B. Braun Medical Inc.
Information provided by:	B. Braun Medical Inc.
ClinicalTrials.gov Identifier:	NCT00916643

Purpose

The objectives of this post-surveillance study are to continue to evaluate the safety and effectiveness of the H.E.L.P. System. The safety and effectiveness will be assessed by evaluating the occurrence of death, cardiovascular events or interventions, angina, and serious unanticipated adverse effects. Laboratory assessments will be made to document low-density lipoprotein cholesterol (LDL-C) reduction and any effects on other blood components. Quality of life assessments will also be made.

The study will also assess the modifications to the H.E.L.P. System, including:

use of a single heparin adsorber, instead of two smaller adsorbers;
change in the supplier of the ultrafilter (from Secon to Toray);
reduction in the number of blood lines from eleven to nine;
change from a single-layer to a two-layer precipitate filter.

The safety and efficacy of the device specific to these modifications will be evaluated by comparing the safety and efficacy data from the patient registry to the data from the initial clinical study on the device as originally designed.

Condition	Intervention	Phase
Familial Hypercholesterolemia	Device: HELP Secura (apheresis treatment)	Phase IV

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Post Marketing Surveillance Study for LDL Apheresis Using H.E.L.P. Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia

MedlinePlus related topics: Blood Thinners Cholesterol

Drug Information available for: Miconazole nitrate Miconazole Clotrimazole

U.S. FDA Resources

Further study details as provided by B. Braun Medical Inc.:

Primary Outcome Measures:

Occurence of Death [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Occurrence of Cardiovascular Events and Interventions [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Serious Unexpected Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Frequency and Severity of CHD Symptoms (angina) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment:	43
Study Start Date:	December 2002
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: H.E.L.P. Secura The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps: Flushing the system with normal saline. Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal. Mixing the plasma with an equal volume of acetate buffer containing heparin. Precipitation of LDL as a complex with heparin. Removing the LDL-heparin precipitate by continuous circulation through a filter. Removing heparin with use of a heparin adsorber. Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin. Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient.	Device: HELP Secura (apheresis treatment) Process is described in Arm (above).

Arms

Assigned Interventions

Experimental: H.E.L.P. Secura

The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:

Flushing the system with normal saline.
Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.
Mixing the plasma with an equal volume of acetate buffer containing heparin.
Precipitation of LDL as a complex with heparin.
Removing the LDL-heparin precipitate by continuous circulation through a filter.
Removing heparin with use of a heparin adsorber.
Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.
Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient.

Device: HELP Secura (apheresis treatment)

Process is described in Arm (above).

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adequate venous access
Laboratory values:
- Hematocrit 30% or greater
- platelet count between 100,000 and 1,000,000/ml
Premenopausal women must be surgically sterilized or be on oral contraceptive therapy and have a negative pregnancy test at the onset of treatment with H.E.L.P.
Patients have familial hypercholesterolemia and have undergone at least 6 months optimal diet and drug therapy and fit group A, B, or C

Exclusion Criteria:

Presence of any of the following conditions:
- untreated hypothyroidism
- decompensated congestive heart failure
- major arrhythmia
- uncontrolled diabetes mellitus
- any malignancy
- disorders associated with excessive bleeding (e.g., peptic ulcer and hemophilia)
- established or suspected intracranial disease which might cause intracranial bleeding if the patient is anticoagulated
- any other medical disorders which lead the treating physician to believe that H.E.L.P. treatment would not be in the best interest of the patient
- current treatment with anticoagulants
- diastolic BP > 100 mmHg recorded in two occasions at least 24 hours apart.
- patients under 18 years of age
- positive test for Hepatitis [Type A (IgM) or B] antigen, Hepatitis C antibody, or HIV (or diagnosis of AIDS)

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Director, H.E.L.P. Business Unit, B. Braun Medical Inc.
ClinicalTrials.gov Identifier:	NCT00916643 History of Changes
Other Study ID Numbers:	BBMI_HELP_Secura
Study First Received:	June 8, 2009
Last Updated:	June 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by B. Braun Medical Inc.:

Hypercholesterolemia
FH
LDL-C
CHD

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders

Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias

ClinicalTrials.gov processed this record on February 09, 2012