Trial Outcomes & Findings for (H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol (NCT NCT00526058)
NCT ID: NCT00526058
Last Updated: 2018-09-14
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Blood samples for LDL-cholesterol determination will be obtained before and after each treatment from week 0 to week 24..
Results posted on
2018-09-14
Participant Flow
Participant milestones
| Measure |
Secura
Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
|
Futura
Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
|
|---|---|---|
|
Period: First Intervention
STARTED
|
9
|
9
|
|
Period: First Intervention
COMPLETED
|
9
|
9
|
|
Period: First Intervention
NOT COMPLETED
|
0
|
0
|
|
Period: Second Intervention
STARTED
|
9
|
9
|
|
Period: Second Intervention
COMPLETED
|
9
|
9
|
|
Period: Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
(H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol
Baseline characteristics by cohort
| Measure |
Secura
n=9 Participants
Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
|
Futura
n=9 Participants
Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
57.0 years
STANDARD_DEVIATION 7.76 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 9.15 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 8.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples for LDL-cholesterol determination will be obtained before and after each treatment from week 0 to week 24..Outcome measures
| Measure |
Secura
n=18 Participants
Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)
|
Futura
n=18 Participants
Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)
|
|---|---|---|
|
Percent Change in Pre- and Post-treatment Reductions of Low-density Lipoprotein Cholesterol (LDL-C) Levels Between the Approved H.E.L.P. System and the Modified H.E.L.P. System.
|
55.28 percent change
Interval 38.6 to 71.9
|
52.89 percent change
Interval 33.3 to 64.0
|
PRIMARY outcome
Timeframe: Assessment based on LDL-C values obtained pre-and post-treatment, analyzed from week 0 to week 24.The primary study endpoint is the change in percent measurements of the pre-to-post apheresis LDL measurements. Blood samples for LDL-cholesterol determination will be obtained before and after each treatment. The pooled difference between the pre- and post-treatment LDL level for each apheresis machine will be reported as the primary endpoint for the system performance.
Outcome measures
| Measure |
Secura
n=18 Participants
Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)
|
Futura
n=18 Participants
Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)
|
|---|---|---|
|
Percent Change of the Pre and Post Treatment Value
|
55.28 percent change
Standard Deviation 9.783
|
52.89 percent change
Standard Deviation 8.228
|
SECONDARY outcome
Timeframe: Analyzed at specific time points throughout the study from week 0 to week 24.Population: Data for all 18 subjects; regardless of treatment sequence
Changes in pre- and post-treatment levels of total cholesterol, high-density lipoprotein cholesterol (HDL-C), total triglycerides, lipoprotein (a), fibrinogen, and C-reactive protein.
Outcome measures
| Measure |
Secura
n=18 Participants
Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)
|
Futura
n=18 Participants
Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)
|
|---|---|---|
|
Clinical Lab Profiles (Pre- and Post-Treatment)
Fibrinogen
|
54.81 percent change
Interval 38.0 to 70.8
|
52.00 percent change
Interval 30.9 to 61.4
|
|
Clinical Lab Profiles (Pre- and Post-Treatment)
C-Reactive Protein
|
58.59 percent change
Interval 45.2 to 67.7
|
48.88 percent change
Interval 35.0 to 59.5
|
|
Clinical Lab Profiles (Pre- and Post-Treatment)
Total Triglycerides
|
63.17 percent change
Interval 40.1 to 77.1
|
71.46 percent change
Interval 40.8 to 89.4
|
|
Clinical Lab Profiles (Pre- and Post-Treatment)
Total Cholesterol
|
50.23 percent change
Interval 40.4 to 62.0
|
48.12 percent change
Interval 34.6 to 59.4
|
|
Clinical Lab Profiles (Pre- and Post-Treatment)
HDL-C
|
11.82 percent change
Interval 5.6 to 19.2
|
7.41 percent change
Interval -3.8 to 15.4
|
|
Clinical Lab Profiles (Pre- and Post-Treatment)
VLDL-C
|
62.14 percent change
Interval 16.5 to 76.3
|
62.65 percent change
Interval -13.2 to 89.2
|
|
Clinical Lab Profiles (Pre- and Post-Treatment)
Lipoprotein (a)
|
59.25 percent change
Interval 43.5 to 74.4
|
49.68 percent change
Interval -19.5 to 74.1
|
SECONDARY outcome
Timeframe: Analyzed at specific time points throughout the study from week 0 to week 24.Population: Data for all 18 subjects; regardless of treatment sequence
Comparison of plasma flow rate recorded with both systems before treatment, after 500 mL of plasma treated, and at the end of each treatment session.
Outcome measures
| Measure |
Secura
n=18 Participants
Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)
|
Futura
n=18 Participants
Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)
|
|---|---|---|
|
Device Parameters
Start of Session; Session 1
|
27.11 flow rate (mL/min)
Standard Deviation 9.380
|
12.39 flow rate (mL/min)
Standard Deviation 5.203
|
|
Device Parameters
Start of Session; Session 2
|
23.41 flow rate (mL/min)
Standard Deviation 10.978
|
8.89 flow rate (mL/min)
Standard Deviation 4.310
|
|
Device Parameters
Start of Session; Session 3
|
28.00 flow rate (mL/min)
Standard Deviation 13.711
|
9.67 flow rate (mL/min)
Standard Deviation 3.664
|
|
Device Parameters
Start of Session; Session 4
|
26.35 flow rate (mL/min)
Standard Deviation 8.838
|
9.17 flow rate (mL/min)
Standard Deviation 5.079
|
|
Device Parameters
Start of Session; Session 5
|
26.29 flow rate (mL/min)
Standard Deviation 6.049
|
10.12 flow rate (mL/min)
Standard Deviation 3.998
|
|
Device Parameters
Start of Session; Session 6
|
27.61 flow rate (mL/min)
Standard Deviation 7.920
|
8.39 flow rate (mL/min)
Standard Deviation 3.898
|
|
Device Parameters
After 500mL; Session 1
|
33.67 flow rate (mL/min)
Standard Deviation 6.380
|
23.44 flow rate (mL/min)
Standard Deviation 2.895
|
|
Device Parameters
After 500mL; Session 4
|
32.11 flow rate (mL/min)
Standard Deviation 3.216
|
23.11 flow rate (mL/min)
Standard Deviation 4.861
|
|
Device Parameters
After 500mL; Session 5
|
34.67 flow rate (mL/min)
Standard Deviation 5.018
|
21.41 flow rate (mL/min)
Standard Deviation 3.501
|
|
Device Parameters
After 500mL; Session 6
|
32.72 flow rate (mL/min)
Standard Deviation 8.456
|
23.72 flow rate (mL/min)
Standard Deviation 2.967
|
|
Device Parameters
End of session; Session 1
|
26.24 flow rate (mL/min)
Standard Deviation 16.510
|
32.24 flow rate (mL/min)
Standard Deviation 17.922
|
|
Device Parameters
End of session; Session 2
|
27.87 flow rate (mL/min)
Standard Deviation 16.587
|
28.44 flow rate (mL/min)
Standard Deviation 8.748
|
|
Device Parameters
End of session; Session 3
|
19.17 flow rate (mL/min)
Standard Deviation 15.946
|
26.44 flow rate (mL/min)
Standard Deviation 9.281
|
|
Device Parameters
End of session; Session 4
|
28.00 flow rate (mL/min)
Standard Deviation 15.326
|
23.29 flow rate (mL/min)
Standard Deviation 7.928
|
|
Device Parameters
End of session; Session 5
|
30.28 flow rate (mL/min)
Standard Deviation 12.750
|
21.50 flow rate (mL/min)
Standard Deviation 10.671
|
|
Device Parameters
End of session; Session 6
|
28.59 flow rate (mL/min)
Standard Deviation 15.133
|
29.06 flow rate (mL/min)
Standard Deviation 5.043
|
|
Device Parameters
After 500mL; Session 2
|
32.59 flow rate (mL/min)
Standard Deviation 5.938
|
22.50 flow rate (mL/min)
Standard Deviation 3.552
|
|
Device Parameters
After 500mL; Session 3
|
31.61 flow rate (mL/min)
Standard Deviation 4.354
|
22.71 flow rate (mL/min)
Standard Deviation 3.601
|
Adverse Events
Secura
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Futura
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Secura
n=18 participants at risk
Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
|
Futura
n=18 participants at risk
Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Blood and lymphatic system disorders
Bacteremia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Endocrine disorders
Hyperkalemia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Cardiac disorders
Atrial Flutter
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Cardiac disorders
Myocardial Ischemia
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
Other adverse events
| Measure |
Secura
n=18 participants at risk
Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
|
Futura
n=18 participants at risk
Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Gastrointestinal disorders
abdominal tenderness
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
diverticulum
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
epigastric discomfort
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
gastritis
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
melaena
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/18
|
16.7%
3/18 • Number of events 3
|
|
Gastrointestinal disorders
stomach discomfort
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
General disorders
fatigue
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
General disorders
malaise
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Infections and infestations
bacteraemia
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
bacterial infection
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
bronchitis
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
sinusitis
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Infections and infestations
urinary tract infection
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
arteriovenous fistula occlusion
|
0.00%
0/18
|
16.7%
3/18 • Number of events 3
|
|
Injury, poisoning and procedural complications
arteriovenous fistula site complication
|
0.00%
0/18
|
11.1%
2/18 • Number of events 2
|
|
Injury, poisoning and procedural complications
arteriovenous fistula site haemorrhage
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
device breakage
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
device failure
|
0.00%
0/18
|
16.7%
3/18 • Number of events 3
|
|
Injury, poisoning and procedural complications
device malfunction
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
device occlusion
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
medical device complication
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Injury, poisoning and procedural complications
road traffic accident
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Investigations
breath sounds abnormal
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Investigations
serum ferritin decreased
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
hyperkalaemia
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
joint swelling
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
skin cancer
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Nervous system disorders
dizziness
|
5.6%
1/18 • Number of events 1
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
sciatica
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
nasal mucosal disorder
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
nasal oedema
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
pharyngolaryngeal pain
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
throat tightness
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
5.6%
1/18 • Number of events 1
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
hypotension
|
0.00%
0/18
|
5.6%
1/18 • Number of events 1
|
Additional Information
Kevin Minnich, Manager Clinical Affairs/Safety Officer
B. Braun Medical Inc.
Phone: 610-596-2358
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Site may publish its own results of the FUTURA Trial after a cooperative publication or 12 months after Sponsor's final evaluation of all the FUTURA Trial data from all sites, whichever occurs first. At least 90 days prior to submitting a manuscript to a publisher or other outside persons or prior to any public presentation, a copy of the abstract, manuscript, or presentation will be provided to Sponsor for review and comment. Sponsor shall have said 90 day period to respond w/ comment.
- Publication restrictions are in place
Restriction type: OTHER