Overview
The aim of the study is to evaluate the efficacy of the SOLACEA-H dialyser, particularly in patients at high risk of haemorrhage, during post-dilution haemodiafiltration sessions with complete or partial heparin sparing. It will be compared with another dialyser (HYDROLINK-NVU)
Description
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.
Eligibility
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