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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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 113 patients received over 6,000 combined H.E.L.P. treatments at six sites between 2000-2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
H.E.L.P. Secura

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.

Participant Flow:   Overall Study
    H.E.L.P. Secura
STARTED   113 
COMPLETED   113 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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:

  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.

Baseline Measures
   H.E.L.P. Secura 
Overall Participants Analyzed 
[Units: Participants]
 113 
Age [1] 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   80 
>=65 years   13 
[1] Not all sites collected this information.
Gender [1] 
[Units: Participants]
 
Female   56 
Male   34 
[1] Not all site collected this information.
Region of Enrollment 
[Units: Participants]
 
United States   113 


  Outcome Measures

1.  Primary:   Occurence of Death   [ Time Frame: Participants were followed for one (1) year following discontinuation of treatment. ]

2.  Primary:   Occurrence of Cardiovascular Events and Interventions   [ Time Frame: Participants were followed for one (1) year following discontinuation of treatment. ]

3.  Primary:   Serious Unexpected Adverse Events   [ Time Frame: Participants were followed for one (1) year following discontinuation of treatment. ]

4.  Primary:   Frequency and Severity of CHD Symptoms (Angina)   [ Time Frame: Participants were followed for one (1) year following discontinuation of treatment. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Kevin Minnich
Organization: B. Braun Medical, Inc.
phone: 610 596 2358
e-mail: kevin.minnich@bbraun.com



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