Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-03-01 @ 4:12 PM
Study NCT ID:
NCT02894034
Status:
UNKNOWN
Last Update Posted:
2018-08-21
First Post:
2016-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is the Measured Diameter of the Optic Nerve Sheath by Cerebral Scan in Patients With Early-phase Meningeal Hemorrhage, Due to a Ruptured Aneurysm, a Prognostic 6-month Mortality Factor ?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'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'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-20', 'studyFirstSubmitDate': '2016-09-05', 'studyFirstSubmitQcDate': '2016-09-05', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient survival', 'timeFrame': 'month 6', 'description': 'patient survival'}]}, 'conditionsModule': {'keywords': ['optic nerve sheath', 'meningeal hemorrhage', 'early phase', 'prognostic'], 'conditions': ['Subarachnoid Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Sub Arachnoid Hemorrhage (SAH) is a public health concern because of its high incidence (7/100 000 inhab.), its mortality rate (25%), and its morbidity rate (50%).', 'detailedDescription': "Sub Arachnoid Hemorrhage (SAH) is a public health concern because of its high incidence (7/100 000 inhab.), its mortality rate (25%), and its morbidity rate (50%).\n\nPrognostic tools are indispensable in guiding and optimizing the care of these patients.\n\nSome diagnostic factors have been identified (e.g. age, comorbidities, ACSOS , GCS, ICP, occurrence of complications) as well as some classification schemes used for grading seriousness of the disease (Hunt and Hess, World Federation of NeuroSurgery).\n\nA tool that is simple, reliable, reproducible, non costly, non invasive, and simple to perform (including remote methods and without changing planned patient care) would be ideal.\n\nThe measurement of the Optic Nerve Sheath Diameter (ONSD,) correlated by MRI and ultrasound in previous studies, with intra-cranial pressure (ICP: a fundamental prognostic factor for SAH) could be one of these tools.\n\nThis measurement, previously demonstrated using ultrasound, could be carried out at the time of the patient's initial cerebral scan.\n\nIn practice, at admission each patient undergoes a cerebral CT scan much more often than an ultrasound (faster, less costly, less technical training required).\n\nTwo preliminary studies seem to suggest that this measurement of ONSD on CTc is a predictive factor for morbi-morbidity in patients having serious traumatic skull fractures.The measurement is reliable, reproducible, non invasive, and non costly, with good sensitivity and specificity.\n\nProving that it is also applicable to SAH could be particularly useful."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient admitted to the Neurosurgical Urgent Care Unit for SAH following a ruputred aneurysm', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years or older\n* Patient admitted to the Neurosurgical Urgent Care Unit for SAH following a ruptured aneurysm\n* Patients or one of their loved ones providing written informed consent\n* Patients with healthcare coverage\n\nExclusion Criteria:\n\n* Unavailability of a CTc in the initial phase (within the first 12 hours) or absence of 1-mm slices from the scan\n* Trauma to the optic globe or optic nerve pathology\n* Preexisting anomalies of ICP or history of neurosurgical cerebral pathologies\n* SAH of non aneurysm origin (e.g. arterio-venous malformation (AVM), tumor, trauma, sepsis)\n* Patients under legal protection'}, 'identificationModule': {'nctId': 'NCT02894034', 'acronym': 'GAINE', 'briefTitle': 'Is the Measured Diameter of the Optic Nerve Sheath by Cerebral Scan in Patients With Early-phase Meningeal Hemorrhage, Due to a Ruptured Aneurysm, a Prognostic 6-month Mortality Factor ?', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Is the Measured Diameter of the Optic Nerve Sheath by Cerebral Scan in Patients With Early Phase Meningeal Hemorrhage Due to a Ruptured Aneurysm a Prognostic 6-month Mortality Factor?', 'orgStudyIdInfo': {'id': 'PI2013_843_0009'}}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'Patrick JEANJEAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}