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Exploring the Modulatory Effect of the Dialyzer Membrane Choice on Hemodialysisassociated Thromboinflammation: a Prospective Randomized Cross-over Trial (CELL-ACT-MEMBR)

26. juni 2026 opdateret af: Universitair Ziekenhuis Brussel

EXPLORING THE MODULATORY EFFECT OF THE DIALYZER MEMBRANE CHOICE ON HEMODIALYSIS ASSOCIATED THROMBOINFLAMMATION: A PROSPECTIVE RANDOMIZED CROSSOVER TRIAL

This clinical trial investigates whether the dialyzer membrane influences hemodialysis-associated thromboinflammation. Specifically, it evaluates the effects of 3 commercially available dialyzer membrane types on immune cell activation and thromboinflammatory responses.

During this trial, participants will undergo standard hemodialysis (3 sessions/week, 4 hours each) and receive three different dialyzer membranes in a crossover design, one for each session with a total study duration of 1 week.

During each session blood samples will be collected (at baseline, hourly, and at the end of dialysis) and additionally, after each session, the used dialysis circuit will be rinsed to recover adherent cells.

The study aims to:

  • Assess whether the dialyzer membrane influences leukocyte and platelet activation .
  • Evaluate whether the dialyzer membrane influences neutrophil extracellular trap (NET) formation.
  • Evaluate whether the dialyzer membrane influences the transcriptomic profiles of immune cells.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Brussels, Belgien, 1090
        • Universitair Ziekenhuis Brussel

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Dialysis vintage ≥ 3 months
  • Treatment schedule of 3x4 hours weekly
  • well functioning dual lumen vascular access
  • Treatment with ASA 80-100mg daily
  • Patients able and agree to provide signed informed consent

Exclusion Criteria:

  • Known vascular access dysfunction defined by FOR CATHETER ACCESS: high dose urokinase use within 4 weeks prior to study participation, planned catheter opacification, Qb <250mL/min within the 2 weeks prior to study participation FOR AV ACCESS: planned AV access intervention, recent AV access intervention within 4 weeks prior to study participation, known AV access dysfunction
  • Known active malignancy and/or active autoimmune disease
  • Known clotting/bleeding disorders
  • Current treatment with immunosuppressive medication
  • Current treatment with P2Y12 receptor antagonists (including clopidogrel, prasugrel, ticlodipine, cangrelor, ticagrelor), epoprostenol and glycoproteine IIb/IIIa receptor antagonists (tirofiban)
  • Current treatment with oral anticoagulation maintenance therapy, including vitamin K antagonists or direct oral anticoagulants
  • Current treatment with low molecular weight heparins (LMWH), heparinoids, bivalirudin, fondaparinux, protein C, or antithrombin.
  • Active infection and/or ongoing systemic antimicrobial treatment.
  • Hospitalized patients
  • Patients treated with heparin-free hemodialysis
  • Recent (<1 week) platelet transfusion or packed cells transfusion
  • Patients receiving intradialytic TPN
  • Patients requiring intravenous iron administration during dialysis (EPO or Parsabiv administration will be postponed until after disconnection from the dialysis circuit and after T240 blood sampling).
  • Patients with cytopenia affecting either white blood cells (WBC < 4x10³/mm³) or platelets defined as (platelet counts <100x10³/mm³)
  • Patients known to have had allergic reactions to PS, PMMA or ATA dialyzer

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Polysulfone dialyzer membrane
Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Xevonta, Braun)
Enhed: Use of a polysulfone membrane
Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Xevonta, Braun)
Aktiv komparator: Asymmetric triacetate dialyzer membrane
Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Solacea, Nipro)
Enhed: Use of an asymmetric triacetate membrane
Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Solacea, Nipro)
Aktiv komparator: Polymethyl methacrylate dialyzer membrane
Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Filtryzer, Toray)
Enhed: Use of a polymethyl methacrylate membrane
Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Filtryzer, Toray)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Differences in leukocyte and platelet counts in rinse fluids of discarded hemodialysis circuit in relation to the dialysate composition
Tidsramme: Over the course of 1 week (3 hemodialysis sessions)
The primary endpoint will be the difference in leukocyte and platelet counts in rinse fluids of discarded hemodialysis circuits in relation to the dialyzer membrane used.
Over the course of 1 week (3 hemodialysis sessions)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Differences in leukocyte and platelet activation markers in blood and rinse fluid samples of discarded hemodialysis circuits measured by flow cytometry in relation to dialysate composition
Tidsramme: over the course of 1 week (3 hemodialysis sessions)
differences in leukocyte and platelet activation markers in blood samples and rinse fluids of discarded hemodialysis circuits in relation to the dialysate composition; assessed by mean fluorescence intensity and the relative number of positive cells for the respective activation marker measured by flow cytometry.
over the course of 1 week (3 hemodialysis sessions)
Differences in coagulation activation and inflammatory markers measured by multiplex-based immunoassays in relation to dialysate composition
Tidsramme: Over the course of 1 week (3 hemodialysis sessions)
Biological evaluation of systemic coagulation activation and inflammation in relation to dialysate composition. Markers will be measured using multiplex-based immunoassays from plasma samples collected.
Over the course of 1 week (3 hemodialysis sessions)
Differences in Neutrophil Extracellular Trap (NET) formation in relation to the dialysate composition
Tidsramme: Over the course of 1 week (3 hemodialysis sessions)
Quantification of NET biomarkers in blood and rinse fluids in relation to the dialysate composition.
Over the course of 1 week (3 hemodialysis sessions)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universitair Ziekenhuis Brussel

Samarbejdspartnere

University of Rochester
Vrije Universiteit Brussel
NIER research group

Efterforskere

  • Ledende efterforsker: Florine Janssens, Medical Doctor, Universitair Ziekenhuis Brussel (UZ Brussel)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. april 2026

Primær færdiggørelse (Faktiske)

15. maj 2026

Studieafslutning (Anslået)

30. oktober 2026

Datoer for studieregistrering

Først indsendt

26. juni 2026

Først indsendt, der opfyldte QC-kriterier

26. juni 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BUN 1432026000041

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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