Dialysis Membrane Reaction
Conditions
Brief summary
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)
Detailed 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.
Interventions
DEVICESOLACEA-H/HYDROLINK-NVU
Patients will receive 6 sessions of washout treatment, followed by a gradual tapering phase (4 sessions maximum) during which the anticoagulant will be reduced from the normal dose to the minimum effective dose (which may be zero) and maintained for a minimum of 2 sessions on the SOLACEA-H, followed by 6 washout sessions, then again a gradual reduction phase (4 sessions maximum) during which the anticoagulant will be reduced from the normal dose to the minimum effective dose (which may be zero) and maintained for a minimum of 2 sessions on the HYDROLINK-NVU.
DEVICEHYDROLINK-NVU/SOLACEA-H
Patients will receive 6 sessions of washout treatment, followed by a gradual tapering phase (4 sessions maximum) during which the anticoagulant will be reduced from the normal dose to the minimum effective dose (which may be zero) and maintained for a minimum of 2 sessions on the HYDROLINK-NVU, followed by 6 washout sessions, then again a gradual reduction phase (4 sessions maximum) during which the anticoagulant will be reduced from the normal dose to the minimum effective dose (which may be zero) and maintained for a minimum of 2 sessions on the SOLACEA-H.
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Euraxi Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multicenter, randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SOLACEA-H vs HYDROLINK-NVU efficacy | 2 month | The primary endpoint is dialysis time, as a marker of a complete and successful dialysis session. This criterion will make it possible to evaluate the effectiveness of a dialysis treatment with SOLACEA-H, complete without total coagulation of the circuit with little or no anticoagulant , with a similar or lesser quantity than that used for the current treatment with HYDROLINK-NVU. |
Countries
France
Outcome results
None listed