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

April 4, 2017 updated by: Baxter Healthcare Corporation

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Easton, Maryland, United States, 21601
        • Advanced Dialysis Center of Easton
    • Virginia
      • Arlington, Virginia, United States, 22202-2714
        • Advanced Dialysis Center of Potomac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

Inclusion Criteria:

  • Hemodialysis patients 18 years of age or older

Exclusion Criteria:

  • n/a

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Priming at each treatment
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.
Priming at each treatment
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)
Each treatment: assessment of the condition of the dialyzer fibers after rinse-back
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.
Each treatment: assessment of the condition of the arterial header after rinse-back
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.
Each treatment: the assessment of the condition of the venous header after rinse-back

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter Healthcare Corporation

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

April 14, 2008

First Submitted That Met QC Criteria

April 14, 2008

First Posted (Estimate)

April 16, 2008

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gambro 1462

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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