A randomized cross-over study with objective quantification of the performance of an asymmetric triacetate and a polysulfone dialysis membrane using different anticoagulation strategies

Abstract

Background Different strategies can be used to counteract coagulation of extracorporeal systems. Systemic anticoagulation is most widely used in routine clinical practice, but can be contraindicated in specific settings. The Solacea™ dialyser, containing the asymmetric triacetate membrane, claims improved biocompatibility, which should result in decreased tendency for coagulation. We quantified the performance of the Solacea™ versus the FX800CORDIAX dialyser regarding resistance to fibre blocking as assessed by micro-computed tomography (CT). Methods This cross-over study with four arms randomized consecutively 10 maintenance haemodialysis patients to a 4-h post-dilution haemodiafiltration session at midweek, using either Solacea™ 19 H or FX800CORDIAX, with either regular or half dose of anticoagulation (EC2017/1459-NCT03820401). Dialyser fibre blocking was visualized in the dialyser outlet potting using a 3D CT scanning technique on micrometre resolution. Extraction ratios of middle molecules [myoglobin, lambda and kappa free light chains (FLCs)] were determined. Results The relative number of open fibres post-dialysis was lower in FX800CORDIAX versus Solacea™ dialyser, and this was irrespective of the anticoagulation dose used or the threshold for counting open fibres. Extraction ratios of FLCs were not different at regular anticoagulation between Solacea™ and FX800CORDIAX (21% ± 4% for kappa and 32% ± 8% for lambda with Solacea™ versus 23% ± 7% and 38% ± 6% for FX800CORDIAX), but were superior with the Solacea™ (34% ± 12% versus 22% ± 8% with FX800CORDIAX; P = 0.02) for myoglobin in case of halving anticoagulation dose. No clinically relevant albumin loss was detected. Conclusions The Solacea™ dialyser seems to be promising for use in conditions where systemic anticoagulation is contraindicated, as even under conditions of low systemic anticoagulation, virtually no signs of fibre blocking could be observed using the sensitive micro-CT scanning technique. This finding is in line with its presumed good performance in terms of biocompatibility.

Impact of Intradialytic Fiber Clotting on Dialyzer Extraction and Solute Removal: A Randomized Cross-Over Study

“…Apart from this thin layer, percentage open bers in the FX800 CorDiax were already lower after a 60min dialysis, and were, for 70% open ber area, further decreased by 66% (interval 60-240min) and 63% (interval 120-240min). These data con rm earlier work, in which it was demonstrated that better biocompatibility resulted in less activation of the coagulation cascade, even at very low levels of anticoagulation 3,5,9 .…”

“…Dialyzer extraction ratios for the middle molecules myoglobin and lambda and kappa free light chains, as measured at 1 hour after dialysis start, were not found associated with dialyzer ber patency post dialysis 3 . This absence of association suggests that ber blocking is a more delayed phenomenon that occurs only later in the dialysis session.…”

“…Power analysis was based on the relative number of patent bers in a previously performed cross-over study in 10 patients. Power was at least 98% (α = 0.05) using two different types of dialyzers 3 The protocol adhered to the Declaration of Helsinki, was approved by the institutional research committee (Ethical Committee -Ghent University Hospital, BC 08511 -B6702020000758 -11/2020), and was registered in www.clinicaltrials.gov (NCT04746391 -09/02/2021 -'Impact of Clotting on Dialyzer E ciency'). Written informed consent was obtained from all included patients.…”

“…Previous research of our group using the gold standard of ber quanti cation by micro-CT indicated that a substantial number of bers can become blocked before this is re ected in a change of routinely observed dialysis parameters or in termination of the dialysis session 2 . We also demonstrated that type of dialyzer (more or less biocompatible), dose and type of anticoagulation strategy, and duration of the dialysis session, next to patient factors such as in ammation, impact substantially on the number of patent bers at the end of the dialysis session [3][4][5][6][7][8] . This study aims to answer two major remaining questions: the kinetics of ber blocking during the dialysis session, and the degree to which unnoticed ber blocking impacts overall dialyzer performance in terms of extraction ratio and total solute removal.…”

Impact of intradialytic fiber clotting on dialyzer extraction and solute removal: a randomized cross-over study

“…Previous research of our group using the gold standard of fiber quantification by micro-CT indicated that a substantial number of fibers can become blocked before this is reflected in a change of routinely observed dialysis parameters or in termination of the dialysis session 2 . We also demonstrated that type of dialyzer (more or less biocompatible), dose and type of anticoagulation strategy, and duration of the dialysis session, next to patient factors such as inflammation, impact substantially on the number of patent fibers at the end of the dialysis session 3 – 8 .…”