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New dialysis filters aim to cut bleeding risk by reducing heparin use

NCT ID NCT05117450

Disease control Sponsor: CHU de Reims Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 special dialysis membranes (HYDROLINK and HeprAN) to see if they can safely reduce or eliminate the need for heparin, a blood thinner that raises bleeding risk. About 302 adults on long-term hemodialysis will take part. The goal is to complete dialysis sessions without using heparin, lowering the chance of bleeding complications.

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

About 302 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

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 : * Patients with Age \> 18 years * Chronic hemodialysis for at least 3 months * Hemodialysis three times a week * On per dialytic heparin therapy (UFH or LMWH) * Affiliated to the French Social Security * Having given their consent for this study exclusion criteria : * Patients undergoing Hemodiafiltration (HDF) * Pregnant or lactating woman * Patient participating in another interventional study * Persons deprived of liberty by judicial or administrative decision * Adults under legal protection (under guardianship or curators) * Persons under a legal protection measure * Patients with a history of HIT * Patients with acquired or congenital coagulation disorders * Pathology with active neoplasia (Myeloma, Waldenström disease, solid cancers) * Patient on an ACE inhibitor (ACE inhibitor) * Patient requiring transfusion during the study period * Patient not hemoglobin-stabilized (mean Hb \< 10g/dL or \>12 g/dL in the previous month) * Patient septic or with significant inflammation (defined as C-reactive protein \> 25mg/L) at the time of inclusion * Patient requiring per-dialytic parenteral nutrition * Patient requiring hospitalization or scheduled surgery during the study period * Vascular access (Arteriovenous Fistula or Arteriovenous graft with the possibility of 2 needles) not allowing a sufficient blood pump flow (\< 300 mL/min determined during the screening phase = blood flow prescribed by the nephrologist) * Patient dialyzing on catheter ("single line" or "double line") or in unipuncture on Arteriovenous fistula on the day of the screening session * Net ultrafiltration on the day of the screening session \> 4000 mL

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Conditions

The condition(s) this trial relates to.

chronic kidney disease kidney failure

As listed by the trial registrant

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

Renal insufficiency

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Chu Reims

    RECRUITING

    Reims, 51092, France

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