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New citrate dialysis cuts bleeding risk for critically ill patients

NCT ID NCT03842657

Disease control Sponsor: University Hospital, Toulouse Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new way to prevent blood clots in the dialysis machine without using heparin, a blood thinner that can cause dangerous bleeding. The method uses a special fluid with citrate and no calcium, and adds calcium back into the body as needed. The study included 97 critically ill patients with a high risk of bleeding and found the approach to be safe and effective.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

97 people

The number who actually took part.

Started

Jul 2019

Finished

Sep 2021

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: will be included in the study, patients * hat require two sessions of dialysis that last for greater than 240 minutes in the 7 days following the inclusion. * With a moderate to high risk of bleeding (platelets count below 150.000/mm3; platelet disorders; bleeding in the last 10 days, surgery or biopsy in the last 10 days or planned in the next 7 days; admission to the ICU) * Older than 18 years of age * That gave written informed consent Exclusion Criteria: will be excluded from the study, patients with * Heparin allergy * On-going treatment by vitamin-K antagonists (INR \> 1.2) or unfractionated heparin (anti-Xa activity \> 0.10).. * Known allergy to the Evodial (Baxter, France) or Cordiax FX100 (Fresenius, France) membranes * On-going treatment by angiotensin converting enzyme inhibitors * Pregnancy or risk of pregnancy * Patient under guardianship

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Conditions

The condition(s) this trial relates to.

dialysis disequilibrium syndrome Hemorrhage hemorrhagic disease thrombotic disease

As listed by the trial registrant

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

Bleeding Hemodialysis complication

Contacts and locations

Locations

  • CHU Toulouse

    Toulouse, France

  • Montpellier Hospital

    Montpellier, France

  • Nimes Hospital

    Nîmes, France

  • Pellegrin Hospital

    Bordeaux, France

  • Tenon Hospital

    Paris, France

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