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Completed

NCT Number: NCT04746391

Impact of Clotting on Dialyzer Efficiency

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.

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Key information

Conditions

Hemodialysis Cardiovascular Diseases Coagulation Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital - Nephrology

Ghent, 9000, Belgium

About this study

This single centre, randomized cross-over study includes ten consecutive stable chronic hemodialysis (HD) patients who experienced stable dialysis sessions during the last 4 weeks, and had no known coagulation disorder, active inflammation or malignancy. Double-needle vascular access is achieved through a native arterio-venous fistula or a well-functioning double lumen tunnelled central venous catheter. Patients are followed during 6 consecutive midweek dialysis sessions. At midweek, patients receive only 1/4th of their regular brand of Low-Molecular Weight Heparin anticoagulation at the beginning of the dialysis session. All test sessions are performed with blood flow at 300mL/min and dialysate flow at 500mL/min in post dilution hemodiafiltration (HDF) mode (substitution flow 75mL/min). Ultrafiltration rates are set according to the patient's interdialytic weight gain and clinical status.

Patients are randomized for hemodialyzer type and dialysis duration:

  • ATA™ Solacea 19H - 60min dialysis
  • ATA™ Solacea 19H - 120min dialysis
  • ATA™ Solacea 19H - 240min dialysis
  • polysulfone FX800Cordiax - 60min dialysis
  • polysulfone FX800Cordiax - 120min dialysis
  • polysulfone FX800Cordiax - 240min dialysis

Just before the termination of the 6 experimental midweek sessions, blood is sampled from the inlet and outlet blood lines. Blood samples are immediately centrifuged and serum vials are stored at -80°C until batch analysis. Post dialysis, dialyzers are rinsed and dried and scanned with micro computed tomography (CT) to count the number of open fibers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • experienced stable dialysis sessions during the last 4 weeks
  • double needle/lumen well-functioning vascular access

Exclusion criteria

  • known coagulation disorder
  • active inflammation
  • malignancy

Treatment and study plan

Dialyzer type

Device

Fiber blocking and dialyzer clearance is calculated in two different commercially available dialyzers

Dialysis duration

Other

Fiber blocking and dialyzer clearance is calculated for three different dialysis durations

Primary outcomes

  1. Fibre blocking in hemodialyzers

    Time frame: 6 weeks

    Fibre blocking as assessed post dialysis by a reference microCT scanning technique

  2. Hemodialyzer performance

    Time frame: 6 weeks

    Dialyzer performance based on calculated clearances for different solutes

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Official study title

Assessment of a Relation Between Dialyzer Clearance and Clotting in Hemodialyzer

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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