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

• Sponsor: Baxter Healthcare Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00659724
• Collaborator: Advanced Dialysis Center of Potomac (Industry), Advanced Dialysis Center of Easton (Industry), Gambro Renal Products, Inc. (Industry)
• Enrollment: 33
• Locations: 2
• Duration (Months): 2
• Patients Per Site: 16.5
• Patients Per Site Per Month: 8.2

Study Details

Study Description

Brief Summary

The purpose of this study is to collect information on the ease of use and thrombogenicity of the Polyflux HD-C4 Big and Fresenius Optiflux 180NR or 200NR dialyzers under conditions of routine clinical use for hemodialysis.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Failure

Detailed Description

This ease of use study involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy. This study is aimed at obtaining feedback from the nursing and technical staff regarding the use and thrombogenicity of the Polyflux HD-C4 Big, and Fresenius Optiflux 180NR or 200NR dialyzers. The dialysis nursing staff will complete ease of use and thrombogenicity assessments following routine dialysis therapy. Any adverse events will be tracked for the study patients.

Study Design

• Study Type: Observational
• Actual Enrollment: 33 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: The Gambro Polyflux HD-C4 Big Ease Of Use And Thrombogenicity Study
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Outcome Measures

Primary Outcome Measures

1. Ease of Use: Priming Blood Side [Priming at each treatment]

   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.

2. Ease of Use: Priming Dialysate Side [Priming at each treatment]

   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.

3. Dialyzer Assessment: Fiber Condition [Each treatment: assessment of the condition of the dialyzer fibers after rinse-back]

   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)

4. Dialyzer Assessment: Arterial Header Condition [Each treatment: assessment of the condition of the arterial header after rinse-back]

   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.

5. Dialyzer Assessment: Venous Header Condition [Each treatment: the assessment of the condition of the venous header after rinse-back]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Hemodialysis patients 18 years of age or older

Exclusion Criteria:

• n/a

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Dialysis Center of Easton	Easton	Maryland	United States	21601
2	Advanced Dialysis Center of Potomac	Arlington	Virginia	United States	22202-2714

Sponsors and Collaborators

• Baxter Healthcare Corporation
• Advanced Dialysis Center of Potomac
• Advanced Dialysis Center of Easton
• Gambro Renal Products, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Baxter Healthcare Corporation
• ClinicalTrials.gov Identifier: NCT00659724
• Other Study ID Numbers: Gambro 1462
• First Posted: Apr 16, 2008
• Last Update Posted: May 10, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Baxter Healthcare Corporation: Dialyzer
• Additional relevant MeSH terms: Renal Insufficiency; Kidney Failure, Chronic

Study Results

Participant Flow

Arm/Group Title	Hemodialysis Patients
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 1-2: Assessment of 180NR or 200NR
STARTED	33
COMPLETED	33
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Hemodialysis Patients
Arm/Group Description	Hemodialysis patients 18 years of age or older receiving routine dialysis treatment for chronic renal failure.
Overall Participants	33
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.0 (11.1)
Sex: Female, Male (Count of Participants)
Female	18 54.5%
Male	15 45.5%
Height (inches) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [inches]	65.6 (4.3)

Outcome Measures

1. Primary Outcome

Title	Ease of Use: Priming Blood Side
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Revaclear MAX	Optiflux F180NR	Optiflux F200NR
Arm/Group Description
Measure Participants	33	33	33
Measure Dialyzers	219	95	97
Very Easy	139	13	13
Acceptable	80	82	84

2. Primary Outcome

Title	Ease of Use: Priming Dialysate Side
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Revaclear MAX	Optiflux F180NR	Optiflux F200NR
Arm/Group Description
Measure Participants	33	33	33
Measure Dialyzers	220	95	97
Perfect	131	4	2
Acceptable	89	91	95

3. Primary Outcome

Title	Dialyzer Assessment: Fiber Condition
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Revaclear MAX	Optiflux F180NR	Optiflux F200NR
Arm/Group Description
Measure Participants	33	33	33
Measure Dialyzers	218	95	97
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Revaclear MAX	Optiflux F180NR	Optiflux F200NR
Arm/Group Description
Measure Participants	33	33	33
Measure Dialyzers	218	95	96
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Revaclear MAX	Optiflux F180NR	Optiflux F200NR
Arm/Group Description
Measure Participants	33	33	33
Measure Dialyzers	217	94	97
Very Good	65	0	0
Good	140	31	35
Poor	7	52	57
Very Poor	5	11	5

Adverse Events

Arm/Group Title	Hemodialysis Patients
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Hemodialysis Patients
	Affected / at Risk (%)	# Events
Total	0/33 (0%)
Other (Not Including Serious) Adverse Events
	Hemodialysis Patients
	Affected / at Risk (%)	# Events
Total	0/33 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.