Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-27 @ 9:27 PM
Study NCT ID:
NCT04763161
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-25
First Post:
2021-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immuno-inflammation in the Acute Phase of an Ischaemic Cerebral Accident Managed by Decompressive Hemicraniectomy: a Case-control Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2021-02-11', 'studyFirstSubmitQcDate': '2021-02-18', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neutrophil polynuclear cells levels', 'timeFrame': 'Day 0'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Cerebrovascular Accident']}, 'descriptionModule': {'briefSummary': 'The objective of the NEUTROSURGERY study is to describe the local and locoregional immuno-inflammatory activity in patients suffering from malignant sylvian ischaemic cerebral accident and treated with decompressive hemicraniectomy compared to a control population of patients to be operated on in neurosurgery for another neurosurgical pathology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The target population concerns patients suffering from malignant sylvian ischaemic cerebral accident and treated with decompressive hemicraniectomy. Eligibility will be assessed as soon as the first results of the MRI or brain scan carried out as part of the thrombolysis alert by the interventional neurologist or neuroradiologist triggering the treatment, in front of a large ischaemic cerebral accident (\\>145 ml).', 'eligibilityCriteria': 'Inclusion Criteria Patients:\n\n* Collegial indication given by a neurologist, a neuroreanimator and a neurosurgeon for HD in the context of a malignant sylvian AIC.\n\nInclusion Criteria Control:\n\n\\- For neurosurgical operations in which cranial, meningeal, vascular (branch of the middle meningeal artery) or cerebral bone tissue is not preserved during the surgical approach.\n\nNon-inclusion Criteria Patients:\n\n* HD carried out in a context of acute cerebral haemorrhage\n* Pre-existing neurological disability: modified Rankin score \\> 2\n* Patient benefiting from a legal protection measure\n\nNon-inclusion Criteria Controls:\n\n* Patient to be operated on for an acute vascular condition: meningeal haemorrhage, subdural or extradural haemorrhage, intra parenchymal haemorrhage.\n* Patient operated on for an osteomeningeal pathology present at the approach site.\n* Patient operated on for an infectious cranial or neuro-meningeal pathology.\n* Patient to be operated on as a result of an intracranial traumatic condition'}, 'identificationModule': {'nctId': 'NCT04763161', 'acronym': 'NEUTROSURGERY', 'briefTitle': 'Immuno-inflammation in the Acute Phase of an Ischaemic Cerebral Accident Managed by Decompressive Hemicraniectomy: a Case-control Study', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Immuno-inflammation in the Acute Phase of an Ischaemic Cerebral Accident Managed by Decompressive Hemicraniectomy: a Case-control Study', 'orgStudyIdInfo': {'id': 'BMR_2021_2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental group', 'description': 'Patients suffering from malignant sylvian ischaemic cerebral accident and treated with decompressive hemicraniectomy.\n\nIntervention is decompressive hemicraniectomy in the context of a malignant sylvian ischaemic cerebral', 'interventionNames': ['Procedure: Decompressive hemicraniectomy']}, {'label': 'Control group', 'description': 'Patients not suffering from AIC, hospitalised in neurosurgery for another reason,\n\nPatients to be opered on which cranial, meningeal, vascular (branch of the middle meningeal artery) or cerebral bone tissue is not preserved during the surgical approach.', 'interventionNames': ['Procedure: neurosurgical operation']}], 'interventions': [{'name': 'Decompressive hemicraniectomy', 'type': 'PROCEDURE', 'description': 'Decompressive hemicraniectomy in the context of a malignat sylvian ischaemic cerebral accident', 'armGroupLabels': ['Experimental group']}, {'name': 'neurosurgical operation', 'type': 'PROCEDURE', 'description': 'neurosurgical operation on which cranial, meningeal, vascular (branch of the middle meningeal artery) or cerebral bone tissue is not preserved during the surgical approach.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Benjamin Dr Maier', 'role': 'CONTACT', 'email': 'bmaier@for.paris', 'phone': '0148036454'}, {'name': 'Amélie Dr Yavchitz', 'role': 'CONTACT', 'email': 'ayavchitz@for.paris', 'phone': '0148036454'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}