SOLACEA-H in Heparin-sparing Haemodialysis

This is a randomised, crossover, open-label, prospective, multicentre post-marketing clinical follow-up study comparing two medical devices used (SOLACEA-H dialyser vs HYDROLINK-NVU dialyser) for their intended purpose.

Each patient will be followed for approximately 2 months, depending on the number of sessions in the anticoagulant reduction phase.

Patients will be offered the study by the investigator during a dialysis session as part of routine practice. If the patient accepts and signs the informed consent form, he or she will receive a succession of dialysis sessions including first the SOLACEA-H then the HYDROLINK-NVU membrane, or vice versa, depending on randomisation.

Inclusion criteria

• On haemodialysis for at least 3 months
• Dialysis in a haemodialysis department of the Ramsay-Santé group
• No active infection
• Medically stable
• Blood flow ≥ 300 ml/min
• Haemoglobin level stable and within recommended norms for a dialysis patient, id est > 10g/dl
• Bipunction
• No known allergy to SOLACEA H or HYDROLINK-NVU
• Willingness to comply with study procedures for the duration of the study
• For women of childbearing age: effective contraception, or absence of active pregnancy (negative pregnancy test)
• Member or beneficiary of a social security scheme
• Patient having been informed and having signed an informed consent form

Exclusion criteria

• Patient on oral anticoagulants for the duration of the study
• Patient on dialysate for the duration of the study
• Patient Medically unstable or fragile
• Severe hepatic impairment
• Patient hospitalised without consent
• Concurrent participation in another clinical study
• Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
• Pregnant, breast-feeding or parturient women
• Patient unable to receive heparin
• Known allergy to latex or phthalates