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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

Tracking Information
First Submitted Date April 14, 2008
First Posted Date April 16, 2008
Results First Submitted Date March 7, 2011
Results First Posted Date June 27, 2011
Last Update Posted Date May 10, 2017
Study Start Date March 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 27, 2011)
  • 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.
  • 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.
  • 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)
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: April 14, 2008)
For every study treatment/dialyzer, the nursing staff will complete a questionnaire regarding the ease of priming and rinse-back, and visually assess residual blood and clots in the dialyzer after rinse-back. [ Time Frame: Priming and rinse-back of each dialyzer ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ease of Use and Blood Clotting for the Gambro Polyflux HD-C4 Big Dialyzer
Official Title The Gambro Polyflux HD-C4 Big Ease Of Use And Thrombogenicity Study
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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)
Condition Chronic Kidney Failure
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 10, 2008)
33
Original Estimated Enrollment
 (submitted: April 14, 2008)
30
Actual Study Completion Date May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Hemodialysis patients 18 years of age or older

Exclusion Criteria:

  • n/a
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00659724
Other Study ID Numbers Gambro 1462
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Baxter Healthcare Corporation
Study Sponsor Baxter Healthcare Corporation
Collaborators
  • Advanced Dialysis Center of Potomac
  • Advanced Dialysis Center of Easton
  • Gambro Renal Products, Inc.
Investigators Not Provided
PRS Account Baxter Healthcare Corporation
Verification Date April 2017