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New filter may protect tiny blood vessels during heart surgery

NCT ID NCT04201119

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether the Oxiris membrane, a filter used during heart-lung machine support, can reduce inflammation and improve blood flow in small blood vessels after heart surgery. 70 adults having elective heart surgery with a long bypass time took part. The membrane aims to remove inflammatory substances from the blood, potentially preventing microcirculation problems that often occur after such operations.

What this could mean

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

Active substance
Oxiris membrane (a device used during heart-lung machine to filter inflammatory substances from the blood)
What this could lead to
If it works, this could point toward a way to reduce complications after heart surgery by improving blood flow in tiny vessels.
What could go wrong
This is a small pilot study with only 70 people, so results may not apply widely. The membrane is used only during surgery, and long-term benefits are uncertain.

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

70 people

The number who actually took part.

Started

Feb 2020

Finished

Aug 2024

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 more than 18 years old * Elective cardiac surgery under CPB with an expected CPB time \> 90 minutes (double valve replacement or valve replacement plus coronary arterial bypass graft (CABG)) * Written informed consent from patient or legal surrogates Exclusion Criteria: * Missing informed consent. * Planned CPB hypothermia \<32ºC * Emergency surgery. * Acute infective endocarditis. * Immunosuppressive treatment or steroids (prednisone \> 0.5 mg/kg/day or equivalent). * AIDS with a CD4 count of \< 200/ μl * Autoimmune disorder. * Transplant receptor. * Advanced Chronic Kidney Disease (CKD 4 or 5). * Renal replacement therapy (RRT) in the last 90 days. * Documented intolerance to study device. * Inclusion in other ongoing study within the last 30 days. * Pregnancy. * Coexisting illness with a high probability of death (inferior to 6 months).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • CHU Amiens-Picardie

    Amiens, 80054, France

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