Dialysis Performance of Different Dialyzer Membranes Using Different Coagulation Strategies

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.

Conditions

• Hemodialysis
• Coagulation

Interventions

DEVICE

choice of dialyzer

Fiber blocking is calculated in different commercially available dialyzers

OTHER

choice of dialysis mode

Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies

OTHER

choice of anticoagulation strategy

Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies

OTHER

preparation of dialyzer

Fiber blocking is calculated in different commercially available dialyzers either preprimed with Albumin or not

Sponsors & Collaborators

• University Ghent

  collaborator OTHER

• University Hospital, Ghent

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-07

Primary Completion

2018-05-30

Completion

2019-01-17

Countries

• Belgium

Study Locations