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| Name | Class |
|---|---|
| Euraxi Pharma | INDUSTRY |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A : SOLACEA-H/HYDROLINK-NVU | Other | The dialysis sessions will take place in the following order : Wash - SOLACEA-H dialysis - Wash - HYDROLINK-NVU dialysis |
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| B : HYDROLINK-NVU/SOLACEA-H | Other | The dialysis sessions will take place in the following order : Wash - HYDROLINK-NVU dialysis - Wash - SOLACEA-H dialysis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOLACEA-H/HYDROLINK-NVU | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| SOLACEA-H vs HYDROLINK-NVU efficacy | 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. | 2 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé La Louvière | Lille | 59800 | France |
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Prospective, multicenter, randomized
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| HYDROLINK-NVU/SOLACEA-H | Device | 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. |
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