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

NCT05117450 | Recruiting

• 1 other identifier: PO20179*
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

• number of hemodialysis session success without heparin

  The success of the hemodialysis session is defined by a dialysis time\> 95% of the prescribed time

  4 weeks

Study Arms (2)

HeprAN first

ACTIVE COMPARATOR

Each included patient will have hemodialysis sessions with HeprAN membrane and then HYDROLINK

Device: Decrease per-dialytic heparin therapy

HYDROLINK first

ACTIVE COMPARATOR

Each included patient will have hemodialysis sessions with HYDROLINK and then HeprAN membrane

Device: Decrease per-dialytic heparin therapy

Interventions

Decrease per-dialytic heparin therapy DEVICE

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)

HYDROLINK first; HeprAN first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Antoine BRACONNIER

CONTACT

03 26 78 41 40; abraconnier@chu-reims.fr

Philippe RIEU

CONTACT

03 26 78 76 38; prieu@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: November 11, 2021
• Study Start: November 17, 2021
• Primary Completion (Estimated): November 17, 2026
• Study Completion (Estimated): December 17, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

FR (1)