SurgeryOXICARDNCT04201119

Effect of Oxiris® Membrane on Microcirculation Following Cardiac Surgery Under Cardiopulmonary Bypass: a Pilot Prospective Monocentric Study (Oxicard Study).

A study testing Oxiris in people with Surgery and Cardiac Event, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Oxiris membrane is an efficient tool for inflammatory cytokines adsorption. Cardiac surgery is followed by an inflammatory state mimicking sepsis. The investigators hypothesized that cytokine adsorption by Oxiris® membrane can attenuate the inflammatory response and thus decrease the microcirculation impairment that… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Surgery, Cardiac Event
What is being tested?: Oxiris
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteFrance
Study dates: 28 Feb 2020to 14 Aug 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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
Pregnancy.
Coexisting illness with a high probability of death (inferior to 6 months).

Who cannot join

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

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

France1 site

CHU Amiens-Picardie
Amiens, 80054

Other trials in France

About this study

Read the detailed description

Conditions: Surgery, Cardiac Event
Being tested: Oxiris
Medical subject headings: Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxirisDevice
Oxiris membrane used on the Prismaflex device (Baxter) dedicated to that type of membrane at blood pump flow of 450 ml min-1

Study groups in NCT04201119
Study group	Role	What they receive
With Oxiris	Experimental	Not described Receives: Device: Oxiris
Without Oxiris	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Improvement in microcirculatory flow measured by sublingual microcirculation device (SDF/OPS) at day 1 following cardiac surgery with Oxiris membrane during CPB time.
Measured: Day 1

Secondary outcomes (51)

Improvement in microcirculation flow with Oxiris® membrane during CPB time at 6 hours after cardiac surgery
Measured: at 6 hours
Improvement in microcirculation flow with Oxiris® membrane during CPB time at 2 days after cardiac surgery
Measured: at 2 days
Decrease of myocardial infarction with Oxiris® membrane
Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality
Measured: at day 30
Decrease of stroke with Oxiris® membrane
Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality
Measured: at day 30
Decrease of ischemic mesenteric with Oxiris® membrane
Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality
Measured: at day 30
Decrease of cardiac arrest with Oxiris® membrane
Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality
Measured: at day 30
Decrease of sudden death with Oxiris® membrane
Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality
Measured: at day 30
Decrease of acute kidney injury with Oxiris® membrane
Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality
Measured: at day 30
Decrease of In-hospital mortality with Oxiris® membrane
Major cardiovascular and cerebral events (MACCE) are myocardial infarction, stroke, ischemic mesenteric, cardiac arrest, sudden death, acute kidney injury, In-hospital mortality
Measured: 30 days
Decrease of cumulative catecholamine use with Oxiris® membrane in the postoperative care period time
catecholamine are dobutamine and norepinephrine
Measured: day 30
Decrease of Requirement for renal replacement therapy events with Oxiris® membrane
Measured: 30 days
Sepsis-related Organ Failure Assessment (SOFA) score with Oxiris® membrane
The quick SOFA score (qSOFA) assists health care providers in estimating the risk of morbidity and mortality due to sepsis.
The score ranges from 0 to 3 points. The presence of 2 or more qSOFA points near the onset of infection was associated with a greater risk of death or prolonged intensive care unit stay.
Measured: 30 days
Simplified Acute Physiology Score (SAPS) II score with Oxiris® membrane
SAPS II was designed to measure the severity of disease for patients admitted to Intensive care units aged 18 or more.
24 hours after admission to the ICU, the measurement has been completed and resulted in an integer point score between 0 and 163 and a predicted mortality between 0% and 100%. No new score can be calculated during the stay. If a patient is discharged from the ICU and readmitted, a new SAPS II score can be calculated.
This scoring system is mostly used to:
describe the morbidity of a patient when comparing the outcome with other patients.
describe the morbidity of a group of patients when comparing the outcome with another group of patients
Measured: 30 days
decrease of day number in ICU with Oxiris® membrane
Measured: 30 days
decrease of hospital stay in days with Oxiris® membrane
Measured: 30 days
Decrease of syndecan-1 expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Measured: 6 hours
Decrease of syndecan-1 expression from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Measured: day 1
Decrease of syndecan-1 expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Measured: day 2
Decrease of heparan-sulfate expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Measured: 6 hours
Decrease of heparan-sulfate expression from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Measured: day 1
Decrease of heparan-sulfate expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Measured: day 2
Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Measured: 6 hours
Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 1 day after surgery with Oxiris® membrane
Measured: day 1
Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Measured: day 2
Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Measured: 6 hours
Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 1 day after surgery with Oxiris® membrane
Measured: one day
Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Measured: two days
Variation of endothelin concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Measured: 6 hours
Variation of endothelin concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
- Comparison endothelin from baseline and at the end of cardiac surgery, H6, day 1 and day2
Measured: one day
Variation of endothelin concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Measured: 2 days
Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Measured: 6 hours
Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Measured: one day
Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane
Measured: two days
Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Measured: 6 hours
Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Measured: one day
Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Measured: 2 days
Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Measured: 6 hours
Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Measured: one day
Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane
Measured: two days
Variation of VEGF concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Measured: 6 hours
Variation of VEGF concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Measured: one day
Variation of VEGF concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane
Measured: two days
Variation of myocardial strain from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Measured: 6 hours
Variation of myocardial strain from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Measured: one day
Variation of myocardial strain from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane
Measured: two days
Variation of diastolic function from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Measured: 6 hours
Variation of diastolic function from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Measured: one day
Variation of diastolic function from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Measured: 2 days
Variation of systolic function from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Measured: 6 hours
Variation of systolic function from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Measured: one day
Variation of systolic function from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 202014 Aug 2024

First posted17 Dec 2019
Study start28 Feb 2020
Primary completion17 Nov 2023
Study completion14 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04201119
Sponsor's protocol ID: PI2019_843_0072
Acronym: OXICARD
Status last verified: Sep 2025
First submitted: 13 Dec 2019
Last updated: 17 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Abou-Arab O, Huette P, Haye G, Guilbart M, Touati G, Diouf M, Beyls C, Dupont H, Mahjoub Y. Effect of the oXiris membrane on microcirculation after cardiac surgery under cardiopulmonary bypass: study protocol for a randomised controlled trial (OXICARD Study). BMJ Open. 2021 Jul 9;11(7):e044424. doi: 10.1136/bmjopen-2020-044424.
PubMed 34244250
Nguyen M, Alvarez M, Evezard C, Ibrahima A, Huette P, Mahjoub Y, Pais-De-Barros JP, Bouhemad B, Masson D, Gautier T, Guinot PG, Abou-Arab O. Impaired endotoxin inactivation, rather than gut translocation, is associated with organ injury in cardiac surgery with cardiopulmonary bypass: An ancilliary analysis of a randomised control trial. Eur J Anaesthesiol. 2026 Sep 1;43(9):762-768. doi: 10.1097/EJA.0000000000002350. Epub 2026 Jan 13.
PubMed 41532670

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Oxiris® Membrane on Microcirculation Following Cardiac Surgery Under Cardiopulmonary Bypass: a Pilot Prospective Monocentric Study (Oxicard Study).
ClinicalTrials.gov ID: NCT04201119
Acronym / sponsor ID: OXICARD / PI2019_843_0072
Conditions: Surgery, Cardiac Event
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
Study start: 28 Feb 2020 (actual)
Primary completion: 17 Nov 2023 (actual)
Study completion: 14 Aug 2024 (actual)
First posted: 17 Dec 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
With Oxiris	Experimental	Device: Oxiris
Without Oxiris	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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
Pregnancy.
Coexisting illness with a high probability of death (inferior to 6 months).

Key exclusion criteria (11 listed)

Missing informed consent.
Planned CPB hypothermia <32ºC
Emergency surgery.
Acute infective endocarditis.
Immunosuppressive treatment or steroids (prednisone > 0.5 mg/kg/day or equivalent).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OxirisOxiris membrane used on the Prismaflex device (Baxter) dedicated to that type of membrane at blood pump flow of 450 ml min-1	Device	With Oxiris

Primary outcome

Improvement in microcirculatory flow measured by sublingual microcirculation device (SDF/OPS) at day 1 following cardiac surgery with Oxiris membrane during CPB time.
Time frame: Day 1

51 secondary outcomes

Improvement in microcirculation flow with Oxiris® membrane during CPB time at 6 hours after cardiac surgery
Time frame: at 6 hours
Improvement in microcirculation flow with Oxiris® membrane during CPB time at 2 days after cardiac surgery
Time frame: at 2 days
Decrease of myocardial infarction with Oxiris® membrane
Time frame: at day 30
Decrease of stroke with Oxiris® membrane
Time frame: at day 30
Decrease of ischemic mesenteric with Oxiris® membrane
Time frame: at day 30
Decrease of cardiac arrest with Oxiris® membrane
Time frame: at day 30
Decrease of sudden death with Oxiris® membrane
Time frame: at day 30
Decrease of acute kidney injury with Oxiris® membrane
Time frame: at day 30
Decrease of In-hospital mortality with Oxiris® membrane
Time frame: 30 days
Decrease of cumulative catecholamine use with Oxiris® membrane in the postoperative care period time
Time frame: day 30
Decrease of Requirement for renal replacement therapy events with Oxiris® membrane
Time frame: 30 days
Sepsis-related Organ Failure Assessment (SOFA) score with Oxiris® membrane
Time frame: 30 days
Simplified Acute Physiology Score (SAPS) II score with Oxiris® membrane
Time frame: 30 days
decrease of day number in ICU with Oxiris® membrane
Time frame: 30 days
decrease of hospital stay in days with Oxiris® membrane
Time frame: 30 days
Decrease of syndecan-1 expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Decrease of syndecan-1 expression from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Time frame: day 1
Decrease of syndecan-1 expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Time frame: day 2
Decrease of heparan-sulfate expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Decrease of heparan-sulfate expression from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Time frame: day 1
Decrease of heparan-sulfate expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Time frame: day 2
Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 1 day after surgery with Oxiris® membrane
Time frame: day 1
Decrease of hyaluronic acid expression from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Time frame: day 2
Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 1 day after surgery with Oxiris® membrane
Time frame: one day
Variation of inflammatory cytokine concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Time frame: two days
Variation of endothelin concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Variation of endothelin concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Time frame: one day
Variation of endothelin concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Time frame: 2 days
Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Time frame: one day
Variation of angiopoietin 1 concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane
Time frame: two days
Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Time frame: one day
Variation of angiopoietin 2 concentration from baseline (prior to surgery) versus 2 days after surgery with Oxiris® membrane
Time frame: 2 days
Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours
Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus one day after surgery with Oxiris® membrane
Time frame: one day
Variation of Tie2 soluble receptor concentration from baseline (prior to surgery) versus two days after surgery with Oxiris® membrane
Time frame: two days
Variation of VEGF concentration from baseline (prior to surgery) versus 6 hours after surgery with Oxiris® membrane
Time frame: 6 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
Results publication: PubMed 34244250Abou-Arab O, Huette P, Haye G, Guilbart M, Touati G, Diouf M, Beyls C, Dupont H, Mahjoub Y. Effect of the oXiris membrane on microcirculation after cardiac surgery under cardiopulmonary bypass: study protocol for a randomised controlled trial (OXICARD Study). BMJ Open. 2021 Jul 9;11(7):e044424. doi: 10.1136/bmjopen-2020-044424.
Derived from this study: PubMed 41532670Nguyen M, Alvarez M, Evezard C, Ibrahima A, Huette P, Mahjoub Y, Pais-De-Barros JP, Bouhemad B, Masson D, Gautier T, Guinot PG, Abou-Arab O. Impaired endotoxin inactivation, rather than gut translocation, is associated with organ injury in cardiac surgery with cardiopulmonary bypass: An ancilliary analysis of a randomised control trial. Eur J Anaesthesiol. 2026 Sep 1;43(9):762-768. doi: 10.1097/EJA.0000000000002350. Epub 2026 Jan 13.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Oxiris in people with Surgery and Cardiac Event, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in microcirculatory flow measured by sublingual microcirculation device (SDF/OPS) at day 1 following cardiac surgery with Oxiris membrane during CPB time. (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04201119, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.