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

Purpose

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

Hemodialysis

MedlinePlus related topics:

Dialysis Kidney Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Other, Prospective

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

Further study details as provided by Gambro Renal Products, Inc.:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	33
Study Start Date:	March 2008
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

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 strictly 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The dialysis nursing staff will complete ease of use and thrombogenicity assessments following routine dialysis therapy of 15 adult patients (18 years of age or older.)

Criteria

Inclusion Criteria:

18 years of age or older

Exclusion Criteria:

n/a routine dialysis patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659724

Locations


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

Gambro Renal Products, Inc.

Advanced Dialysis Center of Potomac

Advanced Dialysis Center of Easton

More Information

Responsible Party:	Gambro Renal Products, Inc. ( Jeffrey Shideman, Ph.D., Director US Clinical Affairs )
Study ID Numbers:	Gambro 1462
First Received:	April 14, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00659724
Health Authority:	United States: Institutional Review Board Not Required

Keywords provided by Gambro Renal Products, Inc.:

Dialyzer

ClinicalTrials.gov processed this record on October 17, 2008

Sponsors and Collaborators:	Gambro Renal Products, Inc. Advanced Dialysis Center of Potomac Advanced Dialysis Center of Easton
Information provided by:	Gambro Renal Products, Inc.
ClinicalTrials.gov Identifier:	NCT00659724