Dialysis Performance of Different Dialyzer Membranes Using Different Coagulation Strategies
Quantification of Dialysis Performance of Different Dialyzer Membranes With Different Coagulation Strategies, Using a Reference microCT Scanning Technique
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2019
CompletedFirst Submitted
Initial submission to the registry
January 22, 2019
CompletedFirst Posted
Study publicly available on registry
January 29, 2019
CompletedJanuary 29, 2019
January 1, 2019
3 months
January 22, 2019
January 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of open fibres in the dialyzer
Number of open fibres as assessed post dialysis by a reference microCT scanning technique
17 weeks
Secondary Outcomes (1)
Extraction ratio of three middle molecules in the dialyzer
4 weeks
Study Arms (17)
Solacea_postHDF_1/1anticoagulation
EXPERIMENTALintervention: * choice of dialyzer: Solacea dialyzer (Nipro, Japan) * choice of dialysis mode: post dilution hemodiafiltration * choice of anticoagulation strategy: standard anticoagulation dose measurements: * blood \& dialysate sampling at 60min after dialysis start * microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
Solacea_postHDF_1/2anticoagulation
EXPERIMENTALintervention: * choice of dialyzer: Solacea dialyzer (Nipro Japan) * choice of dialysis mode: post dilution hemodiafiltration * choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose measurements: * blood \& dialysate sampling at 60min after dialysis start * microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
FX800_postHDF_1/1anticoagulation
EXPERIMENTALintervention: * choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany) * choice of dialysis mode: post dilution hemodiafiltration * choice of anticoagulation strategy: standard anticoagulation dose measurements: * blood \& dialysate sampling at 60min after dialysis start * microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
FX800_postHDF_1/2anticoagulation
EXPERIMENTALintervention: * choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany) * choice of dialysis mode: post dilution hemodiafiltration * choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose measurements: * blood \& dialysate sampling at 60min after dialysis start * microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
Solacea_HD_1/1anticoagulation
EXPERIMENTALintervention: * choice of dialyzer: Solacea dialyzer (Nipro, Japan) * choice of dialysis mode: hemodialysis * choice of anticoagulation strategy: standard anticoagulation dose measurement: \- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
Solacea_HD_1/2anticoagulation
EXPERIMENTALintervention: * choice of dialyzer: Solacea dialyzer (Nipro, Japan) * choice of dialysis mode: hemodialysis * choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose measurements: \- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
FX800_HD_1/1anticoagulation
EXPERIMENTALintervention: * choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany) * choice of dialysis mode: hemodialysis * choice of anticoagulation strategy: standard anticoagulation dose measurements: \- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
FX800_HD_1/2anticoagulation
EXPERIMENTALintervention: * choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany) * choice of dialysis mode: hemodialysis * choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose measurements: \- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
FX800_HD_1/2anticoagulation_albuprime
EXPERIMENTALintervention: * choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany) * choice of dialysis mode: hemodialysis * choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose * preparation of dialyzer: the dialyzer was preprimed with albumin solution measurement: \- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
Evodial_HD_no anticoagulation
EXPERIMENTALintervention: * choice of dialyzer: Evodial 1.3 (Baxter, USA) * choice of dialysis mode: hemodialysis * choice of anticoagulation strategy: no anticoagulation is administered measurement: \- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
Evodial_HD_no anticoagulation_albuprime
EXPERIMENTALintervention: * choice of dialyzer: Evodial 1.3 (Baxter, USA) * choice of dialysis mode: hemodialysis * choice of anticoagulation strategy: no anticoagulation is administered * preparation of dialyzer: the dialyzer was preprimed with albumin solution measurement: \- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
Solacea_preHDF_1/4anticoagulation
EXPERIMENTALintervention: * choice of dialyzer: Solacea dialyzer (Nipro Japan) * choice of dialysis mode: pre dilution hemodiafiltration * choice of anticoagulation strategy: the patient receives only 1/4th of his/her standard anticoagulation dose measurements: \- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
Solacea_postHDF_1/4anticoagulation
EXPERIMENTALintervention: * choice of dialyzer: Solacea dialyzer (Nipro Japan) * choice of dialysis mode: post dilution hemodiafiltration * choice of anticoagulation strategy: the patient receives only 1/4th of his/her standard anticoagulation dose measurements: \- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
Solacea_HD_1/4anticoagulation
EXPERIMENTALintervention: * choice of dialyzer: Solacea dialyzer (Nipro Japan) * choice of dialysis mode: hemodialysis * choice of anticoagulation strategy: the patient receives only 1/4th of his/her standard anticoagulation dose measurements:microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
Solacea_preHDF_no anticoagulation
EXPERIMENTALintervention: * choice of dialyzer: Solacea dialyzer (Nipro Japan) * choice of dialysis mode: pre dilution hemodiafiltration * choice of anticoagulation strategy: no anticoagulation is administered measurements: \- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
Solacea_postHDF_no anticoagulation
EXPERIMENTALintervention: * choice of dialyzer: Solacea dialyzer (Nipro Japan) * choice of dialysis mode: post dilution hemodiafiltration * choice of anticoagulation strategy: no anticoagulation is administered measurements: \- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
Solacea_HD_no anticoagulation
EXPERIMENTALintervention: * choice of dialyzer: Solacea dialyzer (Nipro Japan) * choice of dialysis mode: hemodialysis * choice of anticoagulation strategy: no anticoagulation is administered measurements: \- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
Interventions
Fiber blocking is calculated in different commercially available dialyzers
Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
Fiber blocking is calculated in different commercially available dialyzers either preprimed with Albumin or not
Eligibility Criteria
You may qualify if:
- years or older
- experienced stable dialysis sessions during the last 4 weeks
- double needle/lumen well-functioning vascular access
You may not qualify if:
- known coagulation disorder
- active inflammation
- malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- University Ghentcollaborator
Study Sites (1)
Ghent University Hospital - Nephrology
Ghent, Belgium
Related Publications (2)
Vanommeslaeghe F, Van Biesen W, Dierick M, Boone M, Dhondt A, Eloot S. Micro-computed tomography for the quantification of blocked fibers in hemodialyzers. Sci Rep. 2018 Feb 8;8(1):2677. doi: 10.1038/s41598-018-20898-w.
PMID: 29422614RESULTNatale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.
PMID: 38189593DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2019
First Posted
January 29, 2019
Study Start
March 7, 2018
Primary Completion
May 30, 2018
Study Completion
January 17, 2019
Last Updated
January 29, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share