New filter may protect tiny blood vessels during heart surgery
NCT ID NCT04201119
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
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70 people
The number who actually took part.
- Started
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Feb 2020
- Finished
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Aug 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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