Actively Recruiting
SOLACEA-H in Heparin-sparing Haemodialysis
Led by GCS Ramsay Santé pour l'Enseignement et la Recherche · Updated on 2025-03-25
19
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
Sponsors
G
GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead Sponsor
E
Euraxi Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
SOLACEA-H in Heparin-sparing Haemodialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- On haemodialysis for at least 3 months
- Dialysis performed in a Ramsay-Santé group haemodialysis department
- No active infection
- Medically stable condition
- Blood flow rate of at least 300 ml/min
- Stable haemoglobin level above 10 g/dl within recommended norms for dialysis patients
- Bipuncture access
- No known allergy to SOLACEA-H or HYDROLINK-NVU
- Willingness to comply with study procedures for the entire study duration
- For women of childbearing age: use of effective contraception or negative pregnancy test
- Member or beneficiary of a social security scheme
- Informed consent signed by the patient
You will not qualify if you...
- Taking oral anticoagulants during the study period
- Receiving dialysate during the study period
- Medically unstable or fragile condition
- Severe liver impairment
- Hospitalized without consent
- Participating in another clinical study concurrently
- Under legal protection such as guardianship, curatorship, or deprived of liberty by judicial or administrative decision
- Pregnant, breastfeeding, or recent childbirth
- Unable to receive heparin
- Known allergy to latex or phthalates
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hôpital Privé La Louvière
Lille, France, 59800
Actively Recruiting
Research Team
M
Maxime HOFFMANN, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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