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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hemodialysis; End Stage Renal Disease (ESRD); Thromboinflammation; Hemodialysis Treatment
• Intervention / Treatment: Device: Use of a polysulfone membrane; Device: Use of an asymmetric triacetate membrane; Device: Use of a polymethyl methacrylate membrane

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Polysulfone dialyzer membrane; Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Xevonta, Braun)	Device: Use of a polysulfone membrane; Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Xevonta, Braun)
Active Comparator: Asymmetric triacetate dialyzer membrane; Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Solacea, Nipro)	Device: Use of an asymmetric triacetate membrane; Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Solacea, Nipro)
Active Comparator: Polymethyl methacrylate dialyzer membrane; Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Filtryzer, Toray)	Device: Use of a polymethyl methacrylate membrane; Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Filtryzer, Toray)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in leukocyte and platelet counts in rinse fluids of discarded hemodialysis circuit in relation to the dialysate composition	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Quantification of NET biomarkers in blood and rinse fluids in relation to the dialysate composition.	Over the course of 1 week (3 hemodialysis sessions)

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Collaborators: University of Rochester; Vrije Universiteit Brussel; NIER research group
• Investigators: Principal Investigator: Florine Janssens, Medical Doctor, Universitair Ziekenhuis Brussel (UZ Brussel)

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2026
• Primary Completion (Actual): May 15, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: hemodialysis; neutrophil extracellular traps; thrombin generation; thromboinflammation; dialyzer membrane
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Inflammation; Hematologic Diseases; Embolism and Thrombosis; Renal Insufficiency; Blood Coagulation Disorders; Renal Insufficiency, Chronic; Thrombosis; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Thromboinflammation; Kidney Failure, Chronic
• Other Study ID Numbers: BUN 1432026000041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No