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

Renal Insufficiency Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial Description

The aim of this study is to compare the HYDROLINK™ membrane to the HeprAN™ membrane in a large-scale trial with the strategy of minimizing the dose of peridialytic heparin in order to reduce the risk of bleeding in chronic hemodialysis patients.

Participation in the research will be offered at the time of a hemodialysis session to any eligible patient, i.e., over 18 years of age, who has been on chronic hemodialysis for at least 3 months at a rate of three times a week and who has given their consent to this study. A cross over trial will be performed. Each included patient will have hemodialysis sessions with HYDROLINK™ and HeprAN™ membrane. ;

Related Conditions & MeSH terms

• Renal Insufficiency

• NCT number: NCT05117450
• Study type: Interventional
• Source: CHU de Reims
• Contact: Antoine BRACONNIER
• Phone: 03 26 78 41 40
• Email: abraconnier@chu-reims.fr
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2021
• Completion date: December 17, 2024