Dialysis Membrane ReactionSOLHEPANCT06281028
SOLACEA-H in Heparin-sparing Haemodialysis
A study testing SOLACEA-H/HYDROLINK-NVU and HYDROLINK-NVU/SOLACEA-H in people with Dialysis Membrane Reaction, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis Membrane Reaction
- What is being tested?
- SOLACEA-H/HYDROLINK-NVU and HYDROLINK-NVU/SOLACEA-H
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2024to 2 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SOLACEA-H vs HYDROLINK-NVU for Haemodialysis Sessions in Extracorporeal Circulation Heparin-sparing Situations
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)
Read the 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
- Being tested
- SOLACEA-H/HYDROLINK-NVU, HYDROLINK-NVU/SOLACEA-H
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOLACEA-H/HYDROLINK-NVUDevice
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-HDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| A : SOLACEA-H/HYDROLINK-NVU | Other | The dialysis sessions will take place in the following order :
Wash - SOLACEA-H dialysis - Wash - HYDROLINK-NVU dialysis Receives: Device: SOLACEA-H/HYDROLINK-NVU |
| B : HYDROLINK-NVU/SOLACEA-H | Other | The dialysis sessions will take place in the following order :
Wash - HYDROLINK-NVU dialysis - Wash - SOLACEA-H dialysis Receives: Device: HYDROLINK-NVU/SOLACEA-H |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start20 Nov 2024
- Primary completion2 Feb 2026
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialysis Membrane ReactionStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, multicenter, randomized
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281028
- Sponsor's protocol ID
- 2023-A02280-45
- Acronym
- SOLHEPA
- Status last verified
- Jun 2026
- First submitted
- 20 Feb 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOLACEA-H vs HYDROLINK-NVU for Haemodialysis Sessions in Extracorporeal Circulation Heparin-sparing Situations
- ClinicalTrials.gov ID
- NCT06281028
- Acronym / sponsor ID
- SOLHEPA / 2023-A02280-45
- Conditions
- Dialysis Membrane Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicenter, randomized
| Arm | Type | Receives |
|---|---|---|
| A : SOLACEA-H/HYDROLINK-NVU | Other | Device: SOLACEA-H/HYDROLINK-NVUThe dialysis sessions will take place in the following order : Wash - SOLACEA-H dialysis - Wash - HYDROLINK-NVU dialysis |
| B : HYDROLINK-NVU/SOLACEA-H | Other | Device: HYDROLINK-NVU/SOLACEA-HThe dialysis sessions will take place in the following order : Wash - HYDROLINK-NVU dialysis - Wash - SOLACEA-H dialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOLACEA-H/HYDROLINK-NVUPatients 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 | A : SOLACEA-H/HYDROLINK-NVU |
| HYDROLINK-NVU/SOLACEA-HPatients 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. | Device | B : HYDROLINK-NVU/SOLACEA-H |
Primary outcome
SOLACEA-H vs HYDROLINK-NVU efficacy
Time frame: 2 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOLACEA-H/HYDROLINK-NVU and HYDROLINK-NVU/SOLACEA-H in people with Dialysis Membrane Reaction, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SOLACEA-H vs HYDROLINK-NVU efficacy (time frame: 2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.