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

NCT00659724 | Completed Results

• 1 other identifier: Gambro 1462
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Kidney Failure

Keywords

Dialyzer

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Hemodialysis patients 18 years of age or older

You may not qualify if:

• n/a

Sponsors & Collaborators

• Vantive Health LLC: lead
• Advanced Dialysis Center of Potomac: collaborator
• Advanced Dialysis Center of Easton: collaborator
• Gambro Renal Products, Inc.: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (2)

Advanced Dialysis Center of Easton

Easton, Maryland, 21601, United States

Location

Advanced Dialysis Center of Potomac

Arlington, Virginia, 22202-2714, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global CORP Clinical Trials Disclosure
• Organization: Vantive

Global.CORP.ClinicalTrialsDisclosure@vantive.com

+1 2249484283

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2008
• First Posted: April 16, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: July 24, 2025
• Results First Posted: June 27, 2011

Record last verified: 2025-07

Locations

US (2)