Extra Corporeal Membrane OxygenationMoVa-ECMONCT05237232
Modeling of Intracerebral Vascularization After Extracorporeal Membrane Oxygenation in Children
An observational study of Extra Corporeal Membrane Oxygenation and Decanulated Alive, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Extra corporeal membrane oxygenation (ECMO) is a transient supplementation technique that alleviates hemodynamic and ventilatory failure. Its implementation requires carotid arterial and jugular venous cannulation in newborns or children weighing less than 20 kg. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Extra Corporeal Membrane Oxygenation, Decanulated Alive
- What is being tested?
- Magnetic Resonance Angiography (MRA) additional acquisition time and Modeling cerebral vascularization
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2022to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Newborns, infants and children having been treated with jugulocarotid ECMO and weaned alive off ECMO and newborns treated for hypoxic-ischemic encephalopathy, hospitalized in pediatric intensive care unit (PICU) at Trousseau Hospital.
Who may be able to join
- For everyone :
- Information and non-opposition of holders of parental authority
- Newborn, infant and child <20kg
- Hospitalization in pediatric and neonatal intensive care unit (PICU) of Trousseau Hospital
- Performing a Magnetic Resonance Angiography (MRA) as part of the treatment
- For patients treated with ECMO: study population
Show all 11Show fewer
- Hemodynamic or respiratory failure
- Requiring the use of extracorporeal circulation with jugulo-carotid cannulation
- Weaned alive off Extra corporeal membrane oxygenation (ECMO)
- For patients with hypoxic-ischemic encephalopathy: control population
- hypoxic-ischemic encephalopathy diagnosed at birth
Who cannot join
- Contraindication to MRA
- Opposition of holders of parental authority
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Trousseau
Paris, 75012
Garance Martin, MD, garance.martin@aphp.fr
Pierre-Louis Léger, MD, PhD
About this study
Official title: Cerebral Hemodynamic Impact in Children Depending on the Technique of Carotid Artery Decanulation Technique After Extracorporeal Membrane Oxygenation: Modeling of Intra-cerebral Vascular Flows
Extra corporeal membrane oxygenation (ECMO) is a transient supplementation technique that alleviates hemodynamic and ventilatory failure. Its implementation requires carotid arterial and jugular venous cannulation in newborns or children weighing less than 20 kg. The impact of ECMO on arterial circulation was studied by Doppler ultrasound and shows a redistribution of flows within the circle of Willis.
This study aims to model cerebral flow in children who have been cared from jugulocarotid ECMO and compare cerebral hemodynamics according to the technique of reconstruction of the common carotid artery after decanulation (reconstruction or ligation).
Read the detailed description
Extra corporeal membrane oxygenation (ECMO) is a transient supplementation technique that alleviates hemodynamic and ventilatory failure. Its implementation requires carotid arterial and jugular venous cannulation in newborns or children weighing less than 20 kg. The impact of ECMO on arterial circulation was studied by Doppler ultrasound and shows a redistribution of flows within the circle of Willis.
When ECMO is stopped, carotid decanulation is done either by ligation or by reconstruction, depending on the practices of the surgical team and the peroperative findings. The reconstruction allows a restoration of blood flow to the internal carotid artery and the middle cerebral artery with a disappearance of compensation by the circle of Willis.
Vascular flow modeling is a computational method derived from imaging for the hemodynamic study of fluids, including pressures and flow rates at different points in a vessel. Data from the literature on the modeling of cerebral vascularization in newborns are scarce.
This study aims to model cerebral flow in children who have been cared from jugulocarotid ECMO and compare cerebral hemodynamics according to the technique of reconstruction of the common carotid artery after decanulation (reconstruction or ligation).
- Being tested
- Magnetic Resonance Angiography (MRA) additional acquisition time, Modeling cerebral vascularization
- Keywords
- Extra corporeal membrane oxygenation, Pediatric patients, Arterial circulation, Techniques of carotid decanulation, Circle of Willis, Magnetic Resonance Angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Angiography (MRA) additional acquisition timeOther
Additional acquisition time, time of flight, during brain MRA of the care allowing to obtain the same quality of vascular anatomical visualization as the brain MRA with gadolinium contrast medium injection performed for the care of the patients treated with jugulocarotid ECMO.
Modeling cerebral vascularizationOther
The modeling of cerebral vascularization from CRIMSON software (CaRdiovascular Integrated Modeling \& Simulation) requires several inputs:
- The MRA images
- The cardiac function curve
- The cerebral blood flow
- Measurement of systolic, diastolic and mean arterial blood pressure
| Study group | Role | What they receive |
|---|---|---|
| Patients | Newborns, infants and children hospitalized in pediatric intensive care unit (PICU) at Trousseau Hospital, having been treated with jugulocarotid ECMO and weaned alive off ECMO. Receives: Other: Modeling cerebral vascularization | |
| Controls | Newborns treated for hypoxic-ischemic encephalopathy in the PICU of Trousseau Hospital. Receives: Other: Magnetic Resonance Angiography (MRA) additional acquisition time; Other: Modeling cerebral vascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracerebral arterial flows of patients treated with ECMO
Comparison of intracerebral arterial flows according to the technique of reconstruction of the common carotid artery (reconstruction or ligation) after decanulation from data of MRA performed in weaned living patients off ECMO using computational fluid dynamic.
Measured: 1 month
Secondary outcomes (3)
Modeling of the flow of internal carotid arteries in their extra-cranial portion in children after ECMO
Brain Magnetic Resonance Angiography (MRA)
Measured: 1 month
Cerebral vascularization of patients treated for hypoxic-ischemic encephalopathy
Additional acquisition time, time of flight, during brain Magnetic Resonance Angiography. (MRA) of the care.
Modeling of the normal cerebral vascularization in children and infants / newborns.
Measured: 1 month
Intracerebral arterial flows of patients treated for hypoxic-ischemic encephalopathy
Comparison of intracerebral arterial flows between patients treated with ECMO and those treated for anoxo-ischemia from data of MRA and by using computational fluid dynamic.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start31 Mar 2022
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extra Corporeal Membrane OxygenationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Sabine Irtan, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisGarance Martin, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237232
- Sponsor's protocol ID
- APHP211306
- Other IDs
- 2021-A01935-36
- Acronym
- MoVa-ECMO
- Status last verified
- Aug 2025
- First submitted
- 28 Jan 2022
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Hemodynamic Impact in Children Depending on the Technique of Carotid Artery Decanulation Technique After Extracorporeal Membrane Oxygenation: Modeling of Intra-cerebral Vascular Flows
- ClinicalTrials.gov ID
- NCT05237232
- Acronym / sponsor ID
- MoVa-ECMO / APHP211306
- Keywords
- Extra corporeal membrane oxygenation, Pediatric patients, Arterial circulation, Techniques of carotid decanulation, Circle of Willis, Magnetic Resonance Angiography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 14 Feb 2022 (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.
Extra corporeal membrane oxygenation (ECMO) is a transient supplementation technique that alleviates hemodynamic and ventilatory failure. Its implementation requires carotid arterial and jugular venous cannulation in newborns or children weighing less than 20 kg. The impact of ECMO on arterial circulation was studied by Doppler ultrasound and shows a redistribution of flows within the circle of Willis.
This study aims to model cerebral flow in children who have been cared from jugulocarotid ECMO and compare cerebral hemodynamics according to the technique of reconstruction of the common carotid artery after decanulation (reconstruction or ligation).
Detailed description
Extra corporeal membrane oxygenation (ECMO) is a transient supplementation technique that alleviates hemodynamic and ventilatory failure. Its implementation requires carotid arterial and jugular venous cannulation in newborns or children weighing less than 20 kg. The impact of ECMO on arterial circulation was studied by Doppler ultrasound and shows a redistribution of flows within the circle of Willis.
When ECMO is stopped, carotid decanulation is done either by ligation or by reconstruction, depending on the practices of the surgical team and the peroperative findings. The reconstruction allows a restoration of blood flow to the internal carotid artery and the middle cerebral artery with a disappearance of compensation by the circle of Willis.
Vascular flow modeling is a computational method derived from imaging for the hemodynamic study of fluids, including pressures and flow rates at different points in a vessel. Data from the literature on the modeling of cerebral vascularization in newborns are scarce.
This study aims to model cerebral flow in children who have been cared from jugulocarotid ECMO and compare cerebral hemodynamics according to the technique of reconstruction of the common carotid artery after decanulation (reconstruction or ligation).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Modeling cerebral vascularizationNewborns, infants and children hospitalized in pediatric intensive care unit (PICU) at Trousseau Hospital, having been treated with jugulocarotid ECMO and weaned alive off ECMO. |
| Controls | – | Other: Magnetic Resonance Angiography (MRA) additional acquisition time, Other: Modeling cerebral vascularizationNewborns treated for hypoxic-ischemic encephalopathy in the PICU of Trousseau Hospital. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborns, infants and children having been treated with jugulocarotid ECMO and weaned alive off ECMO and newborns treated for hypoxic-ischemic encephalopathy, hospitalized in pediatric intensive care unit (PICU) at Trousseau Hospital.
Key inclusion criteria (11 listed)
- Information and non-opposition of holders of parental authority
- Newborn, infant and child <20kg
- Hospitalization in pediatric and neonatal intensive care unit (PICU) of Trousseau Hospital
- Performing a Magnetic Resonance Angiography (MRA) as part of the treatment
- For patients treated with ECMO: study population
Key exclusion criteria (2 listed)
- Contraindication to MRA
- Opposition of holders of parental authority
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 |
|---|---|---|
| Magnetic Resonance Angiography (MRA) additional acquisition timeAdditional acquisition time, time of flight, during brain MRA of the care allowing to obtain the same quality of vascular anatomical visualization as the brain MRA with gadolinium contrast medium injection performed for the care of the patients treated with jugulocarotid ECMO. | Other | Controls |
| Modeling cerebral vascularizationThe modeling of cerebral vascularization from CRIMSON software (CaRdiovascular Integrated Modeling \& Simulation) requires several inputs: * The MRA images * The cardiac function curve * The cerebral blood flow * Measurement of systolic, diastolic and mean arterial blood pressure | Other | Controls, Patients |
Primary outcome
Intracerebral arterial flows of patients treated with ECMO
Time frame: 1 month
Comparison of intracerebral arterial flows according to the technique of reconstruction of the common carotid artery (reconstruction or ligation) after decanulation from data of MRA performed in weaned living patients off ECMO using computational fluid dynamic.
3 secondary outcomes
Modeling of the flow of internal carotid arteries in their extra-cranial portion in children after ECMO
Time frame: 1 month
Cerebral vascularization of patients treated for hypoxic-ischemic encephalopathy
Time frame: 1 month
Intracerebral arterial flows of patients treated for hypoxic-ischemic encephalopathy
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- 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.
Sabine Irtan, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Garance Martin, MD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extra Corporeal Membrane Oxygenation and Decanulated Alive, run by Assistance Publique - Hôpitaux de Paris 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 11 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Irtan, MD, PhD (1 71 73 87 98 ext. +33, sabine.irtan@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracerebral arterial flows of patients treated with ECMO (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2025.