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

RecruitingNAAges 18 Years - anyAllCHU de Reims
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In plain words

What the trial is, and whether it could suit you

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 hemorr

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📋 Eligibility rules (as published)
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
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What it tests

  • Decrease per-dialytic heparin therapy
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Where

1 site
Chu Reims
Reims, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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