N/A
N=33
Ease of Use and Blood Clotting for the Gambro Polyflux HD-C4 Big Dialyzer
Chronic Kidney Failure
Bottom Line
View on ClinicalTrials.gov: NCT00659724 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: Primary: Ease of Use: Priming Blood Side — 139; 13; 13; 80 Number of Dialyzers
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vantive Health LLC
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ease of Use: Priming Blood Side |
139; 13; 13; 80; 82; 84 | — |
| PRIMARY Ease of Use: Priming Dialysate Side |
131; 4; 2; 89; 91; 95 | — |
| PRIMARY Dialyzer Assessment: Fiber Condition |
126; 23; 15; 75; 44; 45 | — |
| PRIMARY Dialyzer Assessment: Arterial Header Condition |
155; 0; 0; 49; 66; 64 | — |
| PRIMARY Dialyzer Assessment: Venous Header Condition |
65; 0; 0; 140; 31; 35 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Hemodialysis patients 18 years of age or older
Exclusion Criteria
- n/a
Data sourced from ClinicalTrials.gov (NCT00659724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.