Dialysis Performance of the FX CorAL Membrane

NCT ID: NCT06203795

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2024-12-01

Brief Summary

Anticoagulation remains an important issue in the setting of hemodialysis, and up till now there are some major points on which further research is needed. First, it is important to have a portfolio of the performance of different commercially available dialyzers with respect to fiber clotting. Second, to better estimate the impact of clotting on the overall dialysis performance, clotting kinetics during dialysis should be understood.

The aim of the present project is therefore to quantify the performance of the FX CorAL dialyzer (Fresenius Medical Care, Germany) in settings with reduced anticoagulation, and compare different performance outcomes (percent open fibers, solute removal rates) to those of other commercially available dialyzers. The different outcomes are related to the dialyzer extraction ratio and reduction ratio of small and middle molecules and albumin, the visual scoring of the dialyzer post dialysis, and the anticoagulation properties as assessed by fiber blocking in the dialyzer. Performance parameters at different time steps will allow to better understand clotting kinetics during dialysis.

Detailed Description

The FX CorAL is a polysulfone dialyzer with improved biocompatibility due to the increased polyvinylpyrrolidone (PVP) content on its blood side surface. Herewith, protein adsorption onto the membrane is lower, decreasing initiation of inflammation and suggesting less clotting problems.

The comPERFORM study already revealed the superiority of the FX CorAL 600 dialyzer versus the polysulfone-based Xevonta Hi15 (B. Braun, Germany) and the polyethersulfone-based Elisio 150H (Nipro, Japan) with respect to the clearance of Beta-2-Microglobulin at 60 min after dialysis start. Also the clearance of the larger toxin myoglobin was found superior in the FX CorAL, and removal rates, as calculated over the 240 min post dilution hemodiafiltration sessions, were superior in the FX CorAL for both middle molecules. Furthermore, albumin sieving properties of FX CorAL changed less over time than with the competitors.

Our group previously showed that here is a correlation between myoglobin dialyzer extraction and the percentage of open dialyzer fibers as quantified using the gold standard micro Computed Tomography (CT) scanning technique. However, previous data also suggested that fiber blocking during dialysis is not a linear process, but is rather accelerated during the second half of dialysis. Nevertheless, details about the kinetics of membrane and fiber clotting are still lacking. It can be hypothesized that the membrane pores and fibers in the FX CorAL have an improved tendency to remain open during the entire dialysis session, and that this will result in improved total solute removal, especially for middle molecules. Quantification of dialyzer fiber blocking using micro-CT scanning of dialyzer cross-sections, and this preferably after different durations of dialysis sessions, should be used to test this hypothesis. By including time points for performance measurements, like Extraction Ratio, with blood sampling e.g. at 10, 30, 60 min after dialysis start on the one hand, and at 180 and 240min, it might be possible to better understand clotting kinetics.

Polysulfone and polyethersulfone membranes have previously been associated with hypersensitivity reactions attributed to the use of additives such as PVP to enhance hydrophilic properties. In the FX CorAL however, the PVP is surface-stabilized and does not elute from the inner membrane surface. The Solacea dialyzer (Nipro, Japan), manufactured with an asymmetric triacetate (ATATM) membrane without hydrophilization agents, is also showing a lower risk of hypersensitivity, less decrease in platelets, and high permeability and filtration performance, and might be seen as a competitor for the FX CorAL.

Anticoagulation needs to be well-balanced to avoid an increased risk for bleeding complications on the one hand, and clotting of the extracorporeal circuit resulting in blood loss for the patient on the other hand. A high degree of fiber clotting in the early stage of the dialysis session might also result in decreased solute removal. More biocompatible membranes, such as FX CorAL and Solacea are theoretically less prone to coagulation problems during dialysis and could be used with decreased anticoagulation dose, reducing bleeding problems whilst still maintaining patency. The Solacea dialyzer showed maintained adequacy in conditions where systemic anticoagulation is contraindicated. Up till now, no studies to explore this in the FX CorAL have been performed.

The main questions the investigators want to answer with this study are:

1. How is fiber patency post dialysis in the FX CorAL versus competitors?

2. Can the FX CorAL be safely and adequately used in settings with reduced anticoagulation?

3. How is the time-dependent evolution of dialyzer extraction and clearance of small and middle molecules changing during the course of dialysis?

4. How is the time-dependent evolution of albumin loss?

5. How is the progression of membrane blockage and fiber blockage during the course of dialysis, i.e. during the last hour of a 4 hours dialysis session?

Conditions

Hemodialysis Complication; Anticoagulants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hemodiafiltration with FX CorAL 800 dialyzer

• Patients are dialyzed three consecutive dialysis sessions with an FX CorAL 800 dialyzer, starting on Saturday.
• On Tuesday and Thursday, patients are dialyzed with only a quarter of their regular anticoagulation dose during 4 hours on Tuesday, and 3 hours on Thursday.
• Blood is sampled from the arterial and venous blood line at different time points to determine concentrations of different uremic toxins and albumin

Group Type: EXPERIMENTAL

Anticoagulation dosing

Intervention Type: OTHER

Patients are dialyzed with only one quarter of their regular anticoagulation dose during the sessions on Tuesday and Thursday

Blood sampling

Intervention Type: OTHER

Blood is sampled at start and at 10, 30, 60, 180, and 240 min after dialysis start for the 4 hours dialysis session, and at start and 10 and 180 min after dialysis start for the 3 hours dialysis session.

Duration of the dialysis session

Intervention Type: OTHER

Patients have a washout with their regular dialysis duration on Saturday, a study session of 4 hours dialysis on Tuesday, and a study session of 3 hours dialysis on Thursday

Choice of the hemodialyzer

Intervention Type: DEVICE

Patients are dialyzed with one of the four dialyzers during the entire week, starting at Saturday (i.a. Saturday, Tuesday and Thursday). Block randomization is performed per two weeks. In week 1 and 2, patients are dialyzed with the FX CorAL 800 and the FX 800 Cordiax. In week 3 and 4 of the study, patients are dialyzed with the Solacea 19H and the Xevonta Hi20.

Hemodiafiltration with FX 800 Cordiax dialyzer

• Patients are dialyzed three consecutive dialysis sessions with an FX 800 Cordiax dialyzer, starting on Saturday.
• On Tuesday and Thursday, patients are dialyzed with only a quarter of their regular anticoagulation dose during 4 hours on Tuesday, and 3 hours on Thursday.
• Blood is sampled from the arterial and venous blood line at different time points to determine concentrations of different uremic toxins and albumin

Group Type: EXPERIMENTAL

Anticoagulation dosing

Intervention Type: OTHER

Patients are dialyzed with only one quarter of their regular anticoagulation dose during the sessions on Tuesday and Thursday

Blood sampling

Intervention Type: OTHER

Blood is sampled at start and at 10, 30, 60, 180, and 240 min after dialysis start for the 4 hours dialysis session, and at start and 10 and 180 min after dialysis start for the 3 hours dialysis session.

Duration of the dialysis session

Intervention Type: OTHER

Patients have a washout with their regular dialysis duration on Saturday, a study session of 4 hours dialysis on Tuesday, and a study session of 3 hours dialysis on Thursday

Choice of the hemodialyzer

Intervention Type: DEVICE

Patients are dialyzed with one of the four dialyzers during the entire week, starting at Saturday (i.a. Saturday, Tuesday and Thursday). Block randomization is performed per two weeks. In week 1 and 2, patients are dialyzed with the FX CorAL 800 and the FX 800 Cordiax. In week 3 and 4 of the study, patients are dialyzed with the Solacea 19H and the Xevonta Hi20.

Hemodiafiltration with Solacea 19H dialyzer

• Patients are dialyzed three consecutive dialysis sessions with a Solacea 19H dialyzer, starting on Saturday.
• On Tuesday and Thursday, patients are dialyzed with only a quarter of their regular anticoagulation dose during 4 hours on Tuesday, and 3 hours on Thursday.
• Blood is sampled from the arterial and venous blood line at different time points to determine concentrations of different uremic toxins and albumin

Group Type: EXPERIMENTAL

Anticoagulation dosing

Intervention Type: OTHER

Patients are dialyzed with only one quarter of their regular anticoagulation dose during the sessions on Tuesday and Thursday

Blood sampling

Intervention Type: OTHER

Blood is sampled at start and at 10, 30, 60, 180, and 240 min after dialysis start for the 4 hours dialysis session, and at start and 10 and 180 min after dialysis start for the 3 hours dialysis session.

Duration of the dialysis session

Intervention Type: OTHER

Patients have a washout with their regular dialysis duration on Saturday, a study session of 4 hours dialysis on Tuesday, and a study session of 3 hours dialysis on Thursday

Choice of the hemodialyzer

Intervention Type: DEVICE

Patients are dialyzed with one of the four dialyzers during the entire week, starting at Saturday (i.a. Saturday, Tuesday and Thursday). Block randomization is performed per two weeks. In week 1 and 2, patients are dialyzed with the FX CorAL 800 and the FX 800 Cordiax. In week 3 and 4 of the study, patients are dialyzed with the Solacea 19H and the Xevonta Hi20.

Hemodiafiltration with Xevonta Hi-20

• Patients are dialyzed three consecutive dialysis sessions with a Xevonta Hi-20 dialyzer, starting on Saturday.
• On Tuesday and Thursday, patients are dialyzed with only a quarter of their regular anticoagulation dose during 4 hours on Tuesday, and 3 hours on Thursday.
• Blood is sampled from the arterial and venous blood line at different time points to determine concentrations of different uremic toxins and albumin

Group Type: EXPERIMENTAL

Anticoagulation dosing

Intervention Type: OTHER

Patients are dialyzed with only one quarter of their regular anticoagulation dose during the sessions on Tuesday and Thursday

Blood sampling

Intervention Type: OTHER

Blood is sampled at start and at 10, 30, 60, 180, and 240 min after dialysis start for the 4 hours dialysis session, and at start and 10 and 180 min after dialysis start for the 3 hours dialysis session.

Duration of the dialysis session

Intervention Type: OTHER

Patients have a washout with their regular dialysis duration on Saturday, a study session of 4 hours dialysis on Tuesday, and a study session of 3 hours dialysis on Thursday

Choice of the hemodialyzer

Intervention Type: DEVICE

Patients are dialyzed with one of the four dialyzers during the entire week, starting at Saturday (i.a. Saturday, Tuesday and Thursday). Block randomization is performed per two weeks. In week 1 and 2, patients are dialyzed with the FX CorAL 800 and the FX 800 Cordiax. In week 3 and 4 of the study, patients are dialyzed with the Solacea 19H and the Xevonta Hi20.

Interventions

Anticoagulation dosing

Patients are dialyzed with only one quarter of their regular anticoagulation dose during the sessions on Tuesday and Thursday

Intervention Type: OTHER

Blood sampling

Blood is sampled at start and at 10, 30, 60, 180, and 240 min after dialysis start for the 4 hours dialysis session, and at start and 10 and 180 min after dialysis start for the 3 hours dialysis session.

Intervention Type: OTHER

Duration of the dialysis session

Patients have a washout with their regular dialysis duration on Saturday, a study session of 4 hours dialysis on Tuesday, and a study session of 3 hours dialysis on Thursday

Intervention Type: OTHER

Choice of the hemodialyzer

Patients are dialyzed with one of the four dialyzers during the entire week, starting at Saturday (i.a. Saturday, Tuesday and Thursday). Block randomization is performed per two weeks. In week 1 and 2, patients are dialyzed with the FX CorAL 800 and the FX 800 Cordiax. In week 3 and 4 of the study, patients are dialyzed with the Solacea 19H and the Xevonta Hi20.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• stable chronic hemodialysis patient
• well functioning vascular access

Exclusion Criteria

• known coagulation disorder
• active inflammation
• malignancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wim Van Biesen, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Ghent University Hospital

Ghent, , Belgium

Countries

Belgium

Other Identifiers

ONZ-2023-0017 PATENCY

Identifier Type: -

Identifier Source: org_study_id