Trial Outcomes & Findings for Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy (NCT NCT00916643)
NCT ID: NCT00916643
Last Updated: 2024-04-02
Results Overview
The Categories listed in the table are the Adverse Events (or similar) that resulted in death.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
113 participants
Primary outcome timeframe
Participants were followed for one (1) year following discontinuation of treatment.
Results posted on
2024-04-02
Participant Flow
A total of 113 patients received over 6,000 combined H.E.L.P. treatments at six sites between 2000-2009.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
113
|
|
Overall Study
COMPLETED
|
113
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low-Density Lipoprotein (LDL) Apheresis Using H.E.L.P. Therapy
Baseline characteristics by cohort
| Measure |
H.E.L.P. Secura
n=113 Participants
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.
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|---|---|
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Age, Customized
<=18 years
|
0 participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
80 participants
n=5 Participants
|
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Age, Customized
>=65 years
|
13 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
56 participants
n=5 Participants
|
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Sex/Gender, Customized
Male
|
34 participants
n=5 Participants
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Region of Enrollment
United States
|
113 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Participants were followed for one (1) year following discontinuation of treatment.Population: Inclusion was per protocol.
The Categories listed in the table are the Adverse Events (or similar) that resulted in death.
Outcome measures
| Measure |
H.E.L.P. Secura
n=113 Participants
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.
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|---|---|
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Occurence of Death
Cancer
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1 participants
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Occurence of Death
Pneumonia after open heart surgery
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1 participants
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Occurence of Death
Complications of open-heart surgery
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1 participants
|
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Occurence of Death
Coronary artery disease
|
1 participants
|
PRIMARY outcome
Timeframe: Participants were followed for one (1) year following discontinuation of treatment.Population: The number of participants for analysis was determined per protocol.
Adverse Events reported for Cardiovascular disease not directly related to therapy.
Outcome measures
| Measure |
H.E.L.P. Secura
n=113 Participants
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.
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|---|---|
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Occurrence of Cardiovascular Events and Interventions
Cardiovascular symptoms during therapy
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16 participants
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Occurrence of Cardiovascular Events and Interventions
Cardiovascular symptoms during therapy (serious)
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9 participants
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PRIMARY outcome
Timeframe: Participants were followed for one (1) year following discontinuation of treatment.Population: The number of participants for analysis was determined per protocol.
Outcome measures
| Measure |
H.E.L.P. Secura
n=113 Participants
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.
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|---|---|
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Serious Unexpected Adverse Events
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0 participants
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PRIMARY outcome
Timeframe: Participants were followed for one (1) year following discontinuation of treatment.Population: The number of participants for analysis was determined per protocol.
This is equatable to the incidence of Cardiovascular AEs.
Outcome measures
| Measure |
H.E.L.P. Secura
n=113 Participants
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.
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|---|---|
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Frequency and Severity of CHD Symptoms (Angina)
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23 participants
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Adverse Events
H.E.L.P. Secura
Serious events: 9 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
H.E.L.P. Secura
n=113 participants at risk
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.
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|---|---|
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Cardiac disorders
Angina Pectoris
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0.88%
1/113 • Number of events 1 • From the end of 1999 through 2009.
|
|
Cardiac disorders
Coronary Artery Disease
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0.88%
1/113 • Number of events 1 • From the end of 1999 through 2009.
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Cardiac disorders
General Chest Pain
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4.4%
5/113 • Number of events 5 • From the end of 1999 through 2009.
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Cardiac disorders
Myocardial Infarction
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0.88%
1/113 • Number of events 1 • From the end of 1999 through 2009.
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Cardiac disorders
Unstable Angina
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0.88%
1/113 • Number of events 1 • From the end of 1999 through 2009.
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Other adverse events
| Measure |
H.E.L.P. Secura
n=113 participants at risk
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.
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|---|---|
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Cardiac disorders
Chest Pain
|
5.3%
6/113 • Number of events 9 • From the end of 1999 through 2009.
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General disorders
Clogged Precipitate Filter
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2.7%
3/113 • Number of events 7 • From the end of 1999 through 2009.
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Vascular disorders
Hypotension
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3.5%
4/113 • Number of events 5 • From the end of 1999 through 2009.
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Vascular disorders
Poor Blood Flow
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2.7%
3/113 • Number of events 6 • From the end of 1999 through 2009.
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Vascular disorders
Poor Venous Access
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5.3%
6/113 • Number of events 7 • From the end of 1999 through 2009.
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General disorders
Venous Infiltration
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3.5%
4/113 • Number of events 4 • From the end of 1999 through 2009.
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General disorders
Weakness
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2.7%
3/113 • Number of events 3 • From the end of 1999 through 2009.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER