Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-01 @ 10:12 AM
Study NCT ID:
NCT05237232
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2022-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modeling of Intracerebral Vascularization After Extracorporeal Membrane Oxygenation in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C502936', 'term': 'tocilizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2022-01-28', 'studyFirstSubmitQcDate': '2022-02-09', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intracerebral arterial flows of patients treated with ECMO', 'timeFrame': '1 month', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Modeling of the flow of internal carotid arteries in their extra-cranial portion in children after ECMO', 'timeFrame': '1 month', 'description': 'Brain Magnetic Resonance Angiography (MRA)'}, {'measure': 'Cerebral vascularization of patients treated for hypoxic-ischemic encephalopathy', 'timeFrame': '1 month', 'description': 'Additional acquisition time, time of flight, during brain Magnetic Resonance Angiography. (MRA) of the care.\n\nModeling of the normal cerebral vascularization in children and infants / newborns.'}, {'measure': 'Intracerebral arterial flows of patients treated for hypoxic-ischemic encephalopathy', 'timeFrame': '1 month', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extra corporeal membrane oxygenation', 'Pediatric patients', 'Arterial circulation', 'Techniques of carotid decanulation', 'Circle of Willis', 'Magnetic Resonance Angiography'], 'conditions': ['Extra Corporeal Membrane Oxygenation', 'Decanulated Alive']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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).', 'detailedDescription': '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.\n\nWhen 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.\n\nVascular 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.\n\nThis 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor everyone :\n\n1. Information and non-opposition of holders of parental authority\n2. Newborn, infant and child \\<20kg\n3. Hospitalization in pediatric and neonatal intensive care unit (PICU) of Trousseau Hospital\n4. Performing a Magnetic Resonance Angiography (MRA) as part of the treatment\n\n For patients treated with ECMO: study population\n5. Hemodynamic or respiratory failure\n6. Requiring the use of extracorporeal circulation with jugulo-carotid cannulation\n7. Weaned alive off Extra corporeal membrane oxygenation (ECMO)\n\n For patients with hypoxic-ischemic encephalopathy: control population\n8. hypoxic-ischemic encephalopathy diagnosed at birth\n\nExclusion Criteria:\n\n1. Contraindication to MRA\n2. Opposition of holders of parental authority'}, 'identificationModule': {'nctId': 'NCT05237232', 'acronym': 'MoVa-ECMO', 'briefTitle': 'Modeling of Intracerebral Vascularization After Extracorporeal Membrane Oxygenation in Children', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Cerebral Hemodynamic Impact in Children Depending on the Technique of Carotid Artery Decanulation Technique After Extracorporeal Membrane Oxygenation: Modeling of Intra-cerebral Vascular Flows', 'orgStudyIdInfo': {'id': 'APHP211306'}, 'secondaryIdInfos': [{'id': '2021-A01935-36', 'type': 'OTHER', 'domain': 'IDRCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': '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.', 'interventionNames': ['Other: Modeling cerebral vascularization']}, {'label': 'Controls', 'description': 'Newborns treated for hypoxic-ischemic encephalopathy in the PICU of Trousseau Hospital.', 'interventionNames': ['Other: Magnetic Resonance Angiography (MRA) additional acquisition time', 'Other: Modeling cerebral vascularization']}], 'interventions': [{'name': 'Magnetic Resonance Angiography (MRA) additional acquisition time', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Controls']}, {'name': 'Modeling cerebral vascularization', 'type': 'OTHER', 'description': 'The modeling of cerebral vascularization from CRIMSON software (CaRdiovascular Integrated Modeling \\& Simulation) requires several inputs:\n\n* The MRA images\n* The cardiac function curve\n* The cerebral blood flow\n* Measurement of systolic, diastolic and mean arterial blood pressure', 'armGroupLabels': ['Controls', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Garance Martin, MD', 'role': 'CONTACT', 'email': 'garance.martin@aphp.fr'}, {'name': 'Pierre-Louis Léger, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yaël Levy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Sabine Irtan, MD, PhD', 'role': 'CONTACT', 'email': 'sabine.irtan@aphp.fr', 'phone': '1 71 73 87 98', 'phoneExt': '+33'}, {'name': 'Hélène Morel', 'role': 'CONTACT', 'email': 'helene.morel@aphp.fr', 'phone': '1 71 19 63 46', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Sabine Irtan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Garance Martin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}