Dialysis Performance of Different Dialyzer Membranes Using Different Coagulation Strategies
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03820401 |
Recruitment Status :
Completed
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Coagulation within the dialyzer membrane fibres is an obvious biological sign of bio-incompatibility. To avoid clotting during extracorporeal treatment, an anticoagulant is added to the circuit, resulting in an increased risk for bleeding complications.
In addition, there is evidence that a substantial number of fibers can become blocked before this is reflected in routinely observed parameters, or in termination of the dialysis session. Little is known about the impact of such subclinical clotting on dialyzer performance in terms of solute clearance.
Membrane clogging due to deposition of proteins and red blood cells on the dialysis membrane may influence both the diffusive and convective transport characteristics of the dialyzer membrane before leading to complete dialyzer clotting.
In 2018, the invesitgators described a method to objectively count the number of blocked fibres inside a dialyzer using a micro-CT scanning technique.
In the present trial, the investigators use this method to assess the resistance of the dialyzer to clotting, and to evaluate the impact of subclinical fibre blocking on solute removal and thus performance of a dialyzer during a dialysis session.
The aim of this randomized cross-over study is to objectively quantify the performance of different dialyzer membranes: ATA™ membrane in the Solacea™ dialyzer, polysulfone membrane in the FX800 dialyzer, and the heparin-coated AN membrane in the Evodial dialyzer, and this with different anticoagulation strategies.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hemodialysis Coagulation | Device: choice of dialyzer Other: choice of dialysis mode Other: choice of anticoagulation strategy Other: preparation of dialyzer | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Quantification of Dialysis Performance of Different Dialyzer Membranes With Different Coagulation Strategies, Using a Reference microCT Scanning Technique |
Actual Study Start Date : | March 7, 2018 |
Actual Primary Completion Date : | May 30, 2018 |
Actual Study Completion Date : | January 17, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Solacea_postHDF_1/1anticoagulation
intervention:
measurements:
|
Device: choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies |
Experimental: Solacea_postHDF_1/2anticoagulation
intervention:
measurements:
|
Device: choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies |
Experimental: FX800_postHDF_1/1anticoagulation
intervention:
measurements:
|
Device: choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies |
Experimental: FX800_postHDF_1/2anticoagulation
intervention:
measurements:
|
Device: choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies |
Experimental: Solacea_HD_1/1anticoagulation
intervention:
measurement: - microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers |
Device: choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies |
Experimental: Solacea_HD_1/2anticoagulation
intervention:
measurements: - microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers |
Device: choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies |
Experimental: FX800_HD_1/1anticoagulation
intervention:
measurements: - microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers |
Device: choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies |
Experimental: FX800_HD_1/2anticoagulation
intervention:
measurements: - microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers |
Device: choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies Other: preparation of dialyzer Fiber blocking is calculated in different commercially available dialyzers either preprimed with Albumin or not |
Experimental: FX800_HD_1/2anticoagulation_albuprime
intervention:
measurement: - microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers |
Device: choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies Other: preparation of dialyzer Fiber blocking is calculated in different commercially available dialyzers either preprimed with Albumin or not |
Experimental: Evodial_HD_no anticoagulation
intervention:
measurement: - microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers |
Device: choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies |
Experimental: Evodial_HD_no anticoagulation_albuprime
intervention:
measurement: - microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers |
Device: choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies Other: preparation of dialyzer Fiber blocking is calculated in different commercially available dialyzers either preprimed with Albumin or not |
Experimental: Solacea_preHDF_1/4anticoagulation
intervention:
measurements: - microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers |
Device: choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies |
Experimental: Solacea_postHDF_1/4anticoagulation
intervention:
measurements: - microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers |
Device: choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies |
Experimental: Solacea_HD_1/4anticoagulation
intervention:
measurements:microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers |
Device: choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies |
Experimental: Solacea_preHDF_no anticoagulation
intervention:
measurements: - microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers |
Device: choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies |
Experimental: Solacea_postHDF_no anticoagulation
intervention:
measurements: - microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers |
Device: choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies |
Experimental: Solacea_HD_no anticoagulation
intervention:
measurements: - microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers |
Device: choice of dialyzer
Fiber blocking is calculated in different commercially available dialyzers Other: choice of dialysis mode Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies Other: choice of anticoagulation strategy Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies |
- Number of open fibres in the dialyzer [ Time Frame: 17 weeks ]Number of open fibres as assessed post dialysis by a reference microCT scanning technique
- Extraction ratio of three middle molecules in the dialyzer [ Time Frame: 4 weeks ]Extraction ratio from myoglobin, kappa and lambda free light chains as calculated from their concentrations at the dialyzer inlet en outlet

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 years or older
- experienced stable dialysis sessions during the last 4 weeks
- double needle/lumen well-functioning vascular access
Exclusion Criteria:
- known coagulation disorder
- active inflammation
- malignancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820401
Belgium | |
Ghent University Hospital - Nephrology | |
Gent, Belgium |
Responsible Party: | University Hospital, Ghent |
ClinicalTrials.gov Identifier: | NCT03820401 |
Other Study ID Numbers: |
UGent_FiberClotting_1 |
First Posted: | January 29, 2019 Key Record Dates |
Last Update Posted: | January 29, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
hemodialyzer fibre clotting |