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

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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

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
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.

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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 : March 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008



Primary Outcome Measures :
  1. Ease of Use: Priming Blood Side [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Assessment of dialyzer ease of use and thrombogenicity assessments following routine dialysis therapy of 33 adult patients (18 years of age or older)
Criteria

Inclusion Criteria:

  • Hemodialysis patients 18 years of age or older

Exclusion Criteria:

  • n/a

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659724


Locations
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United States, Maryland
Advanced Dialysis Center of Easton
Easton, Maryland, United States, 21601
United States, Virginia
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.

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Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00659724     History of Changes
Other Study ID Numbers: Gambro 1462
First Posted: April 16, 2008    Key Record Dates
Results First Posted: June 27, 2011
Last Update Posted: May 10, 2017
Last Verified: April 2017
Keywords provided by Baxter Healthcare Corporation:
Dialyzer
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic