NCT03820401

Dialysis Performance of Different Dialyzer Membranes Using Different Coagulation Strategies

Completed NA Last updated 29 January 2019

What this trial tests

NA trial testing choice of dialyzer in Hemodialysis in 20 participants. Completed in 17 January 2019.

Timeline

7 March 2018

Primary endpoint
30 May 2018

17 January 2019

Quick facts

Lead sponsor	University Hospital, Ghent
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	7 March 2018
Primary completion	30 May 2018
Estimated completion	17 January 2019
Sites	1 location across Belgium

Drugs / interventions tested

• choice of dialyzer
• choice of dialysis mode
• choice of anticoagulation strategy
• preparation of dialyzer

Conditions studied

• Hemodialysis — all drugs for Hemodialysis →
• Coagulation — all drugs for Coagulation →

Sponsor

University Hospital, Ghent

Who can join

18 and older, any sex, with Hemodialysis or Coagulation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A randomized cross-over study with objective quantification of the performance of an asymmetric triacetate and a polysulfone dialysis membrane using different anticoagulation strategies.
   Vanommeslaeghe F, Josipovic I, Boone M, Dhondt A, et al · · 2021 · cited 11× · PMID 33564444 · DOI 10.1093/ckj/sfz163
2. Evaluation of Different Dialyzers and the Impact of Predialysis Albumin Priming in Intermittent Hemodialysis With Reduced Anticoagulation.
   Vanommeslaeghe F, De Somer F, Josipovic I, Boone M, et al · · 2019 · cited 10× · PMID 31890995 · DOI 10.1016/j.ekir.2019.07.010
3. How biocompatible haemodialysers can conquer the need for systemic anticoagulation even in post-dilution haemodiafiltration: a cross-over study.
   Vanommeslaeghe F, Josipovic I, Boone M, van der Tol A, et al · · 2021 · cited 6× · PMID 34548919 · DOI 10.1093/ckj/sfaa219