Brief 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 may influence both the diffusive and convective transport characteristics of the dialyzer membrane before leading to complete dialyzer clotting. In 2018, we described a method to objectively count the number of blocked fibres inside a dialyzer using a micro-CT scanning technique. In the present trial, we use this method to assess the number of open fibers post dialysis, and this for three different dialysis durations and in two different dialyzer types. Just before the termination of the dialysis session, dialyzer clearance is assessed for different solutes from concentration measurements in blood samples as taken from the dialyzer inlet and outlet line. The aim of this randomized cross-over study is to objectively quantify the impact of blocked fibers on the performance of different dialyzer membranes: ATA™ (asymmetric triacetate) membrane in the Solacea™ dialyzer, and polysulfone membrane in the FX800Cordiax dialyzer, and this with a decreased anticoagulation dose.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 months study duration

First Submitted

Initial submission to the registry

September 29, 2020

Completed

4 months until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed

3 months until next milestone

Study Start

First participant enrolled

May 19, 2021

Completed

1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1 month

First QC Date

September 29, 2020

Last Update Submit

September 5, 2024

Conditions

Hemodialysis Coagulation

Keywords

HemodialyzerFibre Clotting

Outcome Measures

Primary Outcomes (2)

Fibre blocking in hemodialyzers
Fibre blocking as assessed post dialysis by a reference microCT scanning technique
6 weeks
Hemodialyzer performance
Dialyzer performance based on calculated clearances for different solutes
6 weeks

Study Arms (6)

Solacea_60min

EXPERIMENTAL

* blood sampling from dialyzer inlet and outlet line at 60min, just before dialysis termination * microCT scanning of rinsed and dried hemodialyzer, post dialysis in order to count open fibers