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Ease of Use and Blood Clotting for the Gambro Polyflux HD-C4 Big Dialyzer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00659724
Recruitment Status : Completed
First Posted : April 16, 2008
Results First Posted : June 27, 2011
Last Update Posted : May 10, 2017
Sponsor:
Collaborators:
Advanced Dialysis Center of Potomac
Advanced Dialysis Center of Easton
Gambro Renal Products, Inc.
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Prospective
Condition Chronic Kidney Failure
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hemodialysis Patients
Hide Arm/Group Description Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
Period Title: Weeks 1-2: Assessment of 180NR or 200NR
Started 33
Completed 33
Not Completed 0
Period Title: Weeks 3-4: Assessment of HD-C4 Big
Started 33
Completed 33
Not Completed 0
Arm/Group Title Hemodialysis Patients
Hide Arm/Group Description Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants
66.0  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
18
  54.5%
Male
15
  45.5%
Height  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 33 participants
65.6  (4.3)
1.Primary Outcome
Title Ease of Use: Priming Blood Side
Hide Description

For every study treatment/dialyzer, the nursing staff rated the ease of priming blood side as follows:

Very Easy:Air is easily removed without knocking or clamping procedures. Acceptable:Knocking and/or clamping required for efficient air removal. Difficult:Knocking and/or clamping and additional volume of saline or extended recirculation needed to remove air.

Very Difficult:Air could not be removed.

Time Frame Priming at each treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Revaclear MAX Optiflux F180NR Optiflux F200NR
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 33 33 33
Overall Number of Units Analyzed
Type of Units Analyzed: Dialyzers
219 95 97
Measure Type: Number
Unit of Measure: Number of Dialyzers
Very Easy 139 13 13
Acceptable 80 82 84
2.Primary Outcome
Title Ease of Use: Priming Dialysate Side
Hide Description

For every study treatment/dialyzer, the nursing staff rated the ease of priming dialysate side as follows:

Dialysate Side at 500 ml Priming Volume (check one):

Perfect: No air visible. Acceptable: Some air visible, but considered insignificant. Not Acceptable: Additional actions needed to sufficiently remove air.

Time Frame Priming at each treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Revaclear MAX Optiflux F180NR Optiflux F200NR
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 33 33 33
Overall Number of Units Analyzed
Type of Units Analyzed: Dialyzers
220 95 97
Measure Type: Number
Unit of Measure: Number of Dialyzers
Perfect 131 4 2
Acceptable 89 91 95
3.Primary Outcome
Title Dialyzer Assessment: Fiber Condition
Hide Description

For every study treatment/dialyzer, the nursing staff rated the condition of the dialyzer fibers after rinse-back as follows:

Very Good:All fibers appear white. Good:Few fibers (less than 10) appear PINK / RED. (check one) Poor:Several fibers (more than 10) appear PINK / RED. (check one) Very Poor:Most fibers (more than 75%) appear PINK / RED. (check one)

Time Frame Each treatment: assessment of the condition of the dialyzer fibers after rinse-back
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Revaclear MAX Optiflux F180NR Optiflux F200NR
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 33 33 33
Overall Number of Units Analyzed
Type of Units Analyzed: Dialyzers
218 95 97
Measure Type: Number
Unit of Measure: Number of Dialyzers
Very Good 126 23 15
Good 75 44 45
Poor 12 17 30
Very Poor 5 11 7
4.Primary Outcome
Title Dialyzer Assessment: Arterial Header Condition
Hide Description

For every study treatment/dialyzer, the nursing staff rated the condition of the arterial header after rinse-back as follows:

Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots.

Time Frame Each treatment: assessment of the condition of the arterial header after rinse-back
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Revaclear MAX Optiflux F180NR Optiflux F200NR
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 33 33 33
Overall Number of Units Analyzed
Type of Units Analyzed: Dialyzers
218 95 96
Measure Type: Number
Unit of Measure: Number of Dialyzers
Very Good 155 0 0
Good 49 66 64
Poor 13 26 30
Very Poor 1 3 2
5.Primary Outcome
Title Dialyzer Assessment: Venous Header Condition
Hide Description

For every study treatment/dialyzer, the nursing staff rated the condition of the venous header after rinse-back as follows:

Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots.

Time Frame Each treatment: the assessment of the condition of the venous header after rinse-back
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Revaclear MAX Optiflux F180NR Optiflux F200NR
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 33 33 33
Overall Number of Units Analyzed
Type of Units Analyzed: Dialyzers
217 94 97
Measure Type: Number
Unit of Measure: Number of Dialyzers
Very Good 65 0 0
Good 140 31 35
Poor 7 52 57
Very Poor 5 11 5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hemodialysis Patients
Hide Arm/Group Description Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
All-Cause Mortality
Hemodialysis Patients
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Hemodialysis Patients
Affected / at Risk (%)
Total   0/33 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Hemodialysis Patients
Affected / at Risk (%)
Total   0/33 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffrey R. Shideman PhD
Organization: Gambro Renal Products, Inc.
Phone: 952-835-4018
EMail: Jeff.Shideman@us.gambro.com
Layout table for additonal information
Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00659724    
Other Study ID Numbers: Gambro 1462
First Submitted: April 14, 2008
First Posted: April 16, 2008
Results First Submitted: March 7, 2011
Results First Posted: June 27, 2011
Last Update Posted: May 10, 2017