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NCT Number: NCT07682701

Exploring the Modulatory Effect of the Dialyzer Membrane Choice on Hemodialysisassociated Thromboinflammation: a Prospective Randomized Cross-over 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hemodialysis Blood Coagulation Disorders Cardiovascular Diseases Chronic Disease Disease Attributes Embolism and Thrombosis End Stage Renal Disease (ESRD) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hemodialysis Treatment Inflammation Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Thromboinflammation Thrombosis Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Use of a polysulfone membrane

Device

Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Xevonta, Braun)

Use of an asymmetric triacetate membrane

Device

Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Solacea, Nipro)

Use of a polymethyl methacrylate membrane

Device

Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Filtryzer, Toray)

Primary outcomes

  1. Differences in leukocyte and platelet counts in rinse fluids of discarded hemodialysis circuit in relation to the dialysate composition

    Time frame: 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.

Secondary outcomes

  1. 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

    Time frame: 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.

  2. Differences in coagulation activation and inflammatory markers measured by multiplex-based immunoassays in relation to dialysate composition

    Time frame: 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.

  3. Differences in Neutrophil Extracellular Trap (NET) formation in relation to the dialysate composition

    Time frame: Over the course of 1 week (3 hemodialysis sessions)

    Quantification of NET biomarkers in blood and rinse fluids in relation to the dialysate composition.

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Collaborators

  • NIER research group
  • University of Rochester
  • Vrije Universiteit Brussel

Registry information

Official study title

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

Acronym: CELL-ACT-MEMBR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

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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