SOLACEA-H in Heparin-sparing Haemodialysis (SOLHEPA)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Enrolling

Conditions: Dialysis Membrane Reaction

Treatments: Device: HYDROLINK-NVU/SOLACEA-H; Device: SOLACEA-H/HYDROLINK-NVU

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06281028

2023-A02280-45

Details and patient eligibility

About

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)

Full 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.

Enrollment: 19 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

A : SOLACEA-H/HYDROLINK-NVU

Other group

Description:

The dialysis sessions will take place in the following order : Wash - SOLACEA-H dialysis - Wash - HYDROLINK-NVU dialysis

Treatment:

Device: SOLACEA-H/HYDROLINK-NVU

B : HYDROLINK-NVU/SOLACEA-H

Other group

Description:

The dialysis sessions will take place in the following order : Wash - HYDROLINK-NVU dialysis - Wash - SOLACEA-H dialysis

Treatment:

Device: HYDROLINK-NVU/SOLACEA-H