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Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy (Secura)

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ClinicalTrials.gov Identifier: NCT00916643
Recruitment Status : Completed
First Posted : June 9, 2009
Results First Posted : January 29, 2014
Last Update Posted : March 4, 2014
Sponsor:
Information provided by (Responsible Party):
B. Braun Medical Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Familial Hypercholesterolemia
Intervention Device: HELP Secura (apheresis treatment)
Enrollment 113

Recruitment Details A total of 113 patients received over 6,000 combined H.E.L.P. treatments at six sites between 2000-2009.
Pre-assignment Details  
Arm/Group Title H.E.L.P. Secura
Hide Arm/Group Description

All patients received the same Treatment Arm for this study. Treatments were conducted up to 3 times per week; treatment sessions typ. 2 hours in length.

H.E.L.P. is a device composed of multiple modules and associated disposables to 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.

  1. Flush system with normal saline;
  2. Filter whole blood through 0.2 micron plasma filter for continuous plasma removal;
  3. Mix plasma with equal volume of acetate buffer containing heparin;
  4. Precipitate LDL as a complex with heparin;
  5. Remove LDL-heparin precipitate by continuous circulation through a filter;
  6. Remove heparin with use of a heparin adsorber;
  7. Bicarbonate dialysis and ultrafiltration to produce LDL-free plasma without excess heparin;
  8. Re-mix LDL-free plasma with blood from plasma filter; return reconstituted blood to patient.
Period Title: Overall Study
Started 113
Completed 113
Not Completed 0
Arm/Group Title H.E.L.P. Secura
Hide Arm/Group Description

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:

  1. Flushing the system with normal saline.
  2. Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.
  3. Mixing the plasma with an equal volume of acetate buffer containing heparin.
  4. Precipitation of LDL as a complex with heparin.
  5. Removing the LDL-heparin precipitate by continuous circulation through a filter.
  6. Removing heparin with use of a heparin adsorber.
  7. Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.
  8. Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient.
Overall Number of Baseline Participants 113
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 113 participants
<=18 years 0
Between 18 and 65 years 80
>=65 years 13
[1]
Measure Description: Not all sites collected this information.
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 113 participants
Female 56
Male 34
[1]
Measure Description: Not all site collected this information.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 113 participants
113
1.Primary Outcome
Title Occurence of Death
Hide Description The Categories listed in the table are the Adverse Events (or similar) that resulted in death.
Time Frame Participants were followed for one (1) year following discontinuation of treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Inclusion was per protocol.
Arm/Group Title H.E.L.P. Secura
Hide Arm/Group Description:

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:

  1. Flushing the system with normal saline.
  2. Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.
  3. Mixing the plasma with an equal volume of acetate buffer containing heparin.
  4. Precipitation of LDL as a complex with heparin.
  5. Removing the LDL-heparin precipitate by continuous circulation through a filter.
  6. Removing heparin with use of a heparin adsorber.
  7. Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.
  8. Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
Cancer 1
Pneumonia after open heart surgery 1
Complications of open-heart surgery 1
Coronary artery disease 1
2.Primary Outcome
Title Occurrence of Cardiovascular Events and Interventions
Hide Description Adverse Events reported for Cardiovascular disease not directly related to therapy.
Time Frame Participants were followed for one (1) year following discontinuation of treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined per protocol.
Arm/Group Title H.E.L.P. Secura
Hide Arm/Group Description:

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:

  1. Flushing the system with normal saline.
  2. Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.
  3. Mixing the plasma with an equal volume of acetate buffer containing heparin.
  4. Precipitation of LDL as a complex with heparin.
  5. Removing the LDL-heparin precipitate by continuous circulation through a filter.
  6. Removing heparin with use of a heparin adsorber.
  7. Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.
  8. Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
Cardiovascular symptoms during therapy 16
Cardiovascular symptoms during therapy (serious) 9
3.Primary Outcome
Title Serious Unexpected Adverse Events
Hide Description [Not Specified]
Time Frame Participants were followed for one (1) year following discontinuation of treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined per protocol.
Arm/Group Title H.E.L.P. Secura
Hide Arm/Group Description:

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:

  1. Flushing the system with normal saline.
  2. Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.
  3. Mixing the plasma with an equal volume of acetate buffer containing heparin.
  4. Precipitation of LDL as a complex with heparin.
  5. Removing the LDL-heparin precipitate by continuous circulation through a filter.
  6. Removing heparin with use of a heparin adsorber.
  7. Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.
  8. Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
0
4.Primary Outcome
Title Frequency and Severity of CHD Symptoms (Angina)
Hide Description This is equatable to the incidence of Cardiovascular AEs.
Time Frame Participants were followed for one (1) year following discontinuation of treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined per protocol.
Arm/Group Title H.E.L.P. Secura
Hide Arm/Group Description:

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:

  1. Flushing the system with normal saline.
  2. Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.
  3. Mixing the plasma with an equal volume of acetate buffer containing heparin.
  4. Precipitation of LDL as a complex with heparin.
  5. Removing the LDL-heparin precipitate by continuous circulation through a filter.
  6. Removing heparin with use of a heparin adsorber.
  7. Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.
  8. Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: participants
23
Time Frame From the end of 1999 through 2009.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title H.E.L.P. Secura
Hide Arm/Group Description

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:

  1. Flushing the system with normal saline.
  2. Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.
  3. Mixing the plasma with an equal volume of acetate buffer containing heparin.
  4. Precipitation of LDL as a complex with heparin.
  5. Removing the LDL-heparin precipitate by continuous circulation through a filter.
  6. Removing heparin with use of a heparin adsorber.
  7. Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.
  8. Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient.
All-Cause Mortality
H.E.L.P. Secura
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
H.E.L.P. Secura
Affected / at Risk (%) # Events
Total   9/113 (7.96%)    
Cardiac disorders   
Angina Pectoris   1/113 (0.88%)  1
Coronary Artery Disease   1/113 (0.88%)  1
General Chest Pain * [1]  5/113 (4.42%)  5
Myocardial Infarction   1/113 (0.88%)  1
Unstable Angina   1/113 (0.88%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Events were reported by patients; but not related to treatment and unsubstantiated through further clinical testing.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
H.E.L.P. Secura
Affected / at Risk (%) # Events
Total   29/113 (25.66%)    
Cardiac disorders   
Chest Pain   6/113 (5.31%)  9
General disorders   
Clogged Precipitate Filter   3/113 (2.65%)  7
Venous Infiltration   4/113 (3.54%)  4
Weakness   3/113 (2.65%)  3
Vascular disorders   
Hypotension   4/113 (3.54%)  5
Poor Blood Flow   3/113 (2.65%)  6
Poor Venous Access   6/113 (5.31%)  7
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Client may use the results of the study for its own teaching,research,education,clinical and publication purposes without the payment of royalties or other fees.Client shall submit to Sponsor for review, a copy of any proposed publication resulting from the Study at least thirty(30)days prior to the estimated date of publication, and if no response is received within thirty(30)days of the date submitted to Sponsor,it will be conclusively presumed that the publication may proceed without delay.
Results Point of Contact
Name/Title: Kevin Minnich
Organization: B. Braun Medical, Inc.
Phone: 610 596 2358
Responsible Party: B. Braun Medical Inc.
ClinicalTrials.gov Identifier: NCT00916643     History of Changes
Other Study ID Numbers: BBMI_HELP_Secura
First Submitted: June 8, 2009
First Posted: June 9, 2009
Results First Submitted: July 15, 2013
Results First Posted: January 29, 2014
Last Update Posted: March 4, 2014