Active — Not RecruitingNot Applicable

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

Belgium10 participantsStarted 2026-04-13

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Pat…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT07682701

SponsorUniversitair Ziekenhuis Brussel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-15

View on ClinicalTrials.gov More Hemodialysis trials