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New dialyser aims to cut blood thinner risks for kidney patients

NCT ID NCT06281028

Disease control Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two dialysis filters, SOLACEA-H and HYDROLINK-NVU, to see if SOLACEA-H can allow dialysis sessions with less or no blood thinner (heparin). The trial involves 20 adults who have been on dialysis for at least 3 months and are medically stable. Each participant will try both filters in sequence, gradually reducing blood thinner doses to find the minimum effective amount.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SOLACEA-H dialyser
What this could lead to
If successful, this dialyser could allow safer dialysis for patients at high risk of bleeding by reducing the need for blood thinners.
What could go wrong
This is a small, early-stage study with only 20 participants, so results may not apply to all dialysis patients. The device may not work as well as expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Nov 2024

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dialysis membrane reaction

Contacts and locations

Locations

  • Hôpital Privé La Louvière

    Lille, 59800, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.