SOLACEA-H in Heparin-sparing Haemodialysis

Not Applicable

Recruiting

• Conditions: Dialysis Membrane Reaction
• Interventions: Device: SOLACEA-H/HYDROLINK-NVU; Device: HYDROLINK-NVU/SOLACEA-H

• Registration Number: NCT06281028
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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.

Study Timeline

• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-28
• Study Start: 2024-11-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A : SOLACEA-H/HYDROLINK-NVU	SOLACEA-H/HYDROLINK-NVU	The dialysis sessions will take place in the following order : Wash - SOLACEA-H dialysis - Wash - HYDROLINK-NVU dialysis
B : HYDROLINK-NVU/SOLACEA-H	HYDROLINK-NVU/SOLACEA-H	The dialysis sessions will take place in the following order : Wash - HYDROLINK-NVU dialysis - Wash - SOLACEA-H dialysis

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hôpital Privé La Louvière; 🇫🇷 Lille, France