SOLACEA-H in Heparin-sparing Haemodialysis

Launched by GCS RAMSAY SANTÉ POUR L'ENSEIGNEMENT ET LA RECHERCHE · Feb 20, 2024

Keywords

ClinConnect Summary

The SOLACEA-H trial is studying a new type of dialysis filter called the SOLACEA-H, which is designed to help patients who have a risk of bleeding during their treatment. This trial is particularly focused on patients receiving a specific type of dialysis called post-dilution haemodiafiltration, where less heparin (a blood thinner) is used. Researchers want to see how effective the SOLACEA-H filter is compared to another filter called HYDROLINK-NVU.

To participate in this study, you need to have been on dialysis for at least three months, be medically stable, and have certain blood flow and hemoglobin levels. The trial is open to all gender identities, and you will need to be willing to follow the study procedures and give your consent. If you join, you can expect to be part of a carefully monitored process where your health will be closely observed. It's important to note that certain conditions, such as being on specific medications or having severe health issues, may prevent you from participating.

Gender

ALL

Eligibility 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