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

Launched by CHU DE REIMS · Nov 2, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two types of special membranes used during hemodialysis to see if they can help patients avoid the need for heparin, a blood thinner that can increase the risk of bleeding. The trial compares the HYDROLINK™ membrane, which does not use heparin, to the HeprAN™ membrane, which is coated with heparin. Both membranes aim to prevent blood clots during dialysis sessions, which is important because patients with chronic kidney disease often have issues with blood clotting and anemia.

To participate in the trial, patients must be over 18 years old, have been on hemodialysis for at least three months, and currently receive heparin during their treatment. The trial is looking for individuals who are stable and do not have certain health issues that could complicate the study, like bleeding disorders or active cancer. Participants will receive either the HYDROLINK™ or the HeprAN™ membrane during their hemodialysis sessions and will be monitored for safety and effectiveness. This trial could lead to safer dialysis treatments for patients with chronic kidney disease by reducing the reliance on blood thinners.

Gender

ALL

Eligibility criteria

• 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