SOLACEA-H in Heparin-sparing Haemodialysis

GCS Ramsay Santé pour l'Enseignement et la Recherche20 enrolled

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)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dialysis Membrane Reaction

Interventions

SOLACEA-H/HYDROLINK-NVUDEVICE

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.

HYDROLINK-NVU/SOLACEA-HDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Privé La Louvière

Lille, France

Outcomes

Primary Outcomes

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.

Time frame: 2 month

Data from ClinicalTrials.gov

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