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

Chronic Kidney Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659724
• Other study ID #: Gambro 1462
• Status: Completed
• Phase: N/A
• First received: April 14, 2008
• Last updated: May 27, 2011
• Start date: March 2008
• Est. completion date: May 2008

Study information

• Verified date: May 2011
• Source: Gambro Renal Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hemodialysis patients 18 years of age or older

Exclusion Criteria:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Locations

Country	Name	City	State
United States	Advanced Dialysis Center of Potomac	Arlington	Virginia
United States	Advanced Dialysis Center of Easton	Easton	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Gambro Renal Products, Inc.	Advanced Dialysis Center of Easton, Advanced Dialysis Center of Potomac

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ease of Use: Priming Blood Side	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.	Priming at each treatment	No
Primary	Ease of Use: Priming Dialysate Side	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.	Priming at each treatment	No
Primary	Dialyzer Assessment: Fiber Condition	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)	Each treatment: assessment of the condition of the dialyzer fibers after rinse-back	No
Primary	Dialyzer Assessment: Arterial Header Condition	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.	Each treatment: assessment of the condition of the arterial header after rinse-back	No
Primary	Dialyzer Assessment: Venous Header Condition	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.	Each treatment: the assessment of the condition of the venous header after rinse-back	No