Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06203795 |
| Other study ID # |
UGhent |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2, 2023 |
| Est. completion date |
August 31, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
University Hospital, Ghent |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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?
