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

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.

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