SOLACEA-H in Heparin-sparing Haemodialysis

Dialysis Membrane Reaction Clinical Trial

— SOLHEPA  

Official title:

SOLACEA-H vs HYDROLINK-NVU for Haemodialysis Sessions in Extracorporeal Circulation Heparin-sparing Situations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06281028
• Other study ID #: 2023-A02280-45
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Maxime HOFFMANN, MD
• Phone: 6 86 70 91 23
• Email: maxime.hoffmann[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 19
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dialysis Membrane Reaction

Intervention

Device:
• SOLACEA-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.
• HYDROLINK-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.

Locations

Country	Name	City	State
France	Hôpital Privé La Louvière	Lille

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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