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

Completed

Conditions: Chronic Kidney Failure

Registration Number: NCT00659724

Lead Sponsor: Vantive Health LLC

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 33

Inclusion Criteria

Hemodialysis patients 18 years of age or older

Exclusion Criteria

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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)
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (2): Advanced Dialysis Center of Easton
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Easton, Maryland, United States
Advanced Dialysis Center of Potomac
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Arlington, Virginia, United States