RecruitingNot ApplicableNCT05117450

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


Sponsor

CHU de Reims

Enrollment

302 participants

Start Date

Nov 17, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two types of dialysis filter membranes — HYDROLINK and HeprAN — in patients on regular hemodialysis (kidney dialysis) who currently receive heparin (a blood thinner) during each session to prevent clotting. The goal is to test whether these special membranes allow doctors to safely reduce or stop heparin use, which would reduce bleeding risk. **You may be eligible if...** - You are over 18 and have been on hemodialysis three times per week for at least 3 months - You are currently receiving heparin (either unfractionated or low molecular weight) during dialysis - You are covered by French Social Security - You have given consent to participate **You may NOT be eligible if...** - You are on hemodiafiltration (a different type of dialysis) - You have a history of heparin-induced thrombocytopenia (a dangerous reaction to heparin) - You have a clotting disorder - You are pregnant or breastfeeding - You have active cancer, sepsis, or significant inflammation - You are on ACE inhibitor medications - Your hemoglobin is unstable or you need transfusions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDecrease 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)


Locations(1)

Chu Reims

Reims, France

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NCT05117450


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