Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients

NCT05117450 · tracked via the Priya Life Science France tracker

Sponsor

CHU de Reims

Phase

Not applicable

Started

2021-11-17

Last updated

2025-11-21

Condition(s) studied

Renal Insufficiency

Investigational drug(s) / intervention(s)

Decrease per-dialytic heparin therapy

Decrease per-dialytic heparin therapy: Decrease per-dialytic heparin therapy with the HYDROLINK membrane (dialyzer NV-21U, surface 2.1m², Toray industry, Tokyo, Japan) and with the HeprAN membrane (dialyzer Evodial 2.2, surface 2.15 m2, Hospal SAS, Meyzieu, France)

Study summary

Chronic kidney disease (CKD) results from the progressive and irreversible destruction of the kidneys. As of December 31, 2018, there were 89,692 people in France undergoing replacement therapy, including 49,271 (55%) on dialysis and 40,421 (45%) with a functioning kidney transplant. The primary treatment modality is currently hemodialysis. It is known to activate the coagulation cascade and blood platelets, leading to thrombus formation and premature termination of the hemodialysis session. This loss of circuitry results in a decrease in session time leading to an insufficient dialysis dose and blood loss in patients who are already often anemic due to their chronic renal failure.

To avoid this complication, current recommendations recommend the use of unfractionated heparin (UFH) or low molecular weight heparin (LMWH) during the hemodialysis session at the cost of an obligatory hemorrhagic risk due to the systemic administration of heparin. However, this risk of bleeding is already very high, due to platelet dysfunction, a direct consequence of uremic toxin impregnation in these patients. In addition, this hemodialysis population is frequently exposed to antiplatelet agents and anticoagulants (heparin or VKA), which aggravate the hemorrhagic risk inherent to renal pathology.

In this context, bioactive membranes such as the HeprAN™ membrane, coated in heparin, have been developed to minimize or even eliminate the need for anticoagulation during sessions in chronic hemodialysis patients. Several studies with this membrane have demonstrated the absence of the need for additional heparin in populations with no particular bleeding risk and in populations at risk of bleeding: post-operative (HepZero study), patients on VKA.

The HYDROLINK™ membrane offers the same anticoagulant prospects as the HeprAN™ membrane, but its mode of action involves the use of a copolymer with hydrophilic properties, making it possible to avoid the presence of heparin. This membrane would have an influence on platelet aggregation. It would also make it possible to avoid the risk of heparin-induced thrombocytopenia (HIT) by completely excluding heparin from the dialysis session

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

inclusion criteria : * Patients with Age \> 18 years * Chronic hemodialysis for at least 3 months * Hemodialysis three times a week * On per dialytic heparin therapy (UFH or LMWH) * Affiliated to the French Social Security * Having given their consent for this study exclusion criteria : * Patients undergoing Hemodiafiltration (HDF) * Pregnant or lactating woman * Patient participating in another interventional study * Persons deprived of liberty by judicial or administrative decision * Adults under legal protection (under guardianship or curators) * Persons under a legal protection measure * Patients with a history of HIT * Patients with acquired or congenital coagulation disorders * Pathology with active neoplasia (Myeloma, Waldenström disease, solid cancers) * Patient on an ACE inhibitor (ACE inhibitor) * Patient requiring transfusion during the study period * Patient not hemoglobin-stabilized (mean Hb \< 10g/dL or \>12 g/dL in the previous month) * Patient septic or with significant inflammation (defined as C-reactive protein \> 25mg/L) at the time of inclusion * Patient requiring per-dialytic parenteral nutrition * Patient requiring hospitalization or scheduled surgery during the study period * Vascular access (Arteriovenous Fistula or Arteriovenous graft with the possibility of 2 needles) not allowing a sufficient blood pump flow (\< 300 mL/min determined during the screening phase = blood flow prescribed by the nephrologist) * Patient dialyzing on catheter ("single line" or "double line") or in unipuncture on Arteriovenous fistula on the day of the screening session * Net ultrafiltration on the day of the screening session \> 4000 mL

Primary outcome measure(s)

number of hemodialysis session success without heparin — 4 weeks
The success of the hemodialysis session is defined by a dialysis time\> 95% of the prescribed time

Trial sites (1)

Facility	City	Region	Status
Chu Reims	Reims	France	Recruiting

More CHU de Reims trials in France

Prevalence and Consequences of Antiphospholipid Syndrome in Patients Aged 65 and Over With Ischemic Strokes (IS) Recruiting

Neutrophil Extracellular Traps in Different Forms of Systemic Sclerosis Recruiting

Evaluation of the Agreement Between a Consultation With a Nurse Acquiring Three-dimensional Intraoral Images Made With a 3D Intraoral Camera and the Standard Consultation With a Dental Surgeon, in Institutionalized Elderly Subjects Starting soon

Intraoral Scanners as Periodontal and Dental Pathologies Diagnosis Tools Recruiting

Evaluation of the Efficacy of the Addition of Magnesium Sulfate to Morphine on the Occurrence of Acute Urinary Retention Following Epidural Anesthesia for Cesarean Section. Recruiting

Other trials for the same condition

Study of the Quality of Life in School Aged-children With Posterior Urethral Valves Recruiting

Food Frequency Questionnaire to Assess Sodium Intake Recruiting

Tolerability and Safety of CARDIOMEMS™ Intracardiac Continuous Cardiac Hemodynamic Monitoring Device in Patients with Cardio Renal Syndrome with Severe Renal Impairment Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05117450 on ClinicalTrials.gov ↗ ← All trials in France