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Completed

NCT Number: NCT00659724

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Advanced Dialysis Center of Easton, Easton, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemodialysis patients 18 years of age or older

Exclusion criteria

  • n/a

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Vantive Health LLC

Industry

Collaborators

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

Registry information

Official study title

The Gambro Polyflux HD-C4 Big Ease Of Use And Thrombogenicity Study

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 16, 2008
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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