Evaluating SOLACEA-H Dialyser in Heparin-sparing Dialysis
SOLACEA-H vs HYDROLINK-NVU for Haemodialysis Sessions in Extracorporeal Circulation Heparin-sparing Situations
NA · GCS Ramsay Santé pour l'Enseignement et la Recherche · NCT06281028
This study is testing a new dialysis machine called SOLACEA-H to see if it works better than another machine for patients who are at high risk of bleeding and need less heparin during treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 19 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche (other) |
| Locations | 1 site (Lille) |
| Trial ID | NCT06281028 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of the SOLACEA-H dialyser in patients at high risk of bleeding during haemodiafiltration sessions that minimize heparin use. It is a randomized, crossover, open-label, multicentre follow-up study comparing the SOLACEA-H dialyser with the HYDROLINK-NVU dialyser. Patients will undergo a series of dialysis sessions using both dialysers, with their performance evaluated over approximately two months. The study will be conducted in a routine clinical setting, with patient consent obtained prior to participation.
Who should consider this trial
Good fit: Ideal candidates are patients on haemodialysis for at least three months who are medically stable and have a stable haemoglobin level.
Not a fit: Patients on oral anticoagulants or those with severe hepatic impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer dialysis options for patients at risk of hemorrhage.
How similar studies have performed: While this approach is innovative, it builds on existing knowledge of dialysis techniques, and similar studies have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lille
- Hôpital Privé La Louvière — Lille, France (RECRUITING)
Study contacts
- Study coordinator: Maxime HOFFMANN, MD
- Email: maxime.hoffmann@gmail.com
- Phone: 6 86 70 91 23
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dialysis Membrane Reaction