Actively Recruiting
Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients
Led by CHU de Reims · Updated on 2025-11-21
302
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged over 18 years
- Receiving chronic hemodialysis for at least 3 months
- Undergoing hemodialysis three times a week
- Currently on peridialytic heparin therapy (UFH or LMWH)
- Affiliated with the French Social Security
- Provided consent to participate in the study
You will not qualify if you...
- Patients undergoing Hemodiafiltration (HDF)
- Pregnant or lactating women
- Participating in another interventional study
- Persons deprived of liberty by judicial or administrative decision
- Adults under legal protection (guardianship or curatorship)
- Persons under any legal protection measure
- History of heparin-induced thrombocytopenia (HIT)
- Acquired or congenital coagulation disorders
- Active cancers (Myeloma, Waldenström disease, solid tumors)
- Currently on ACE inhibitor medication
- Requiring transfusion during the study period
- Hemoglobin not stabilized (mean Hb < 10 g/dL or > 12 g/dL in the last month)
- Septic or with significant inflammation (C-reactive protein > 25 mg/L) at inclusion
- Requiring per-dialytic parenteral nutrition
- Hospitalization or scheduled surgery during the study
- Vascular access not allowing sufficient blood pump flow (< 300 mL/min)
- Dialyzing on catheter or unipuncture on arteriovenous fistula on screening day
- Net ultrafiltration > 4000 mL on screening day
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chu Reims
Reims, France, 51092
Actively Recruiting
Research Team
A
Antoine BRACONNIER
CONTACT
P
Philippe RIEU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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