NCT06281028

SOLACEA-H in Heparin-sparing Haemodialysis

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dialysis Membrane Reaction

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2024-11-20
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2024-02-28
• Last updated: 2025-03-25

Locations

1 site across 1 country: France