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NCT07682701Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 6 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
10 (actual)
First submitted
26 Jun 2026
Start date
13 Apr 2026
Primary completion date
15 May 2026
Lead sponsor
Universitair Ziekenhuis Brussel
NCT number
NCT07682701

What you commit to

  • Study type: Interventional
  • Participants enrolled: 10
  • From 13 Apr 2026 to the primary completion date, 15 May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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.
  • Patients treated with heparin-free hemodialysis
  • Patients receiving intradialytic TPN

Other illness

  • Known active malignancy and/or active autoimmune disease
  • Known clotting/bleeding disorders
  • Active infection and/or ongoing systemic antimicrobial treatment.
  • Patients known to have had allergic reactions to PS, PMMA or ATA dialyzer

Lab values

  • Recent (\<1 week) platelet transfusion or packed cells transfusion
  • Patients with cytopenia affecting either white blood cells (WBC \< 4x10³/mm³) or platelets defined as (platelet counts \<100x10³/mm³)

Other

  • Hospitalized patients
  • 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).

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitair Ziekenhuis Brussel
Coordinator of this site? Confirm its status
BrusselsBelgiumUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.