Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-03 @ 9:02 PM
Study NCT ID:
NCT02890004
Status:
UNKNOWN
Last Update Posted:
2018-02-23
First Post:
2016-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Patients With Subarachnoid Hemorrhage
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2020-03-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-22', 'studyFirstSubmitDate': '2016-08-24', 'studyFirstSubmitQcDate': '2016-08-31', 'lastUpdatePostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'at day 0'}, {'measure': 'Survival', 'timeFrame': 'at 6 months'}, {'measure': 'Survival', 'timeFrame': 'at 12 months'}], 'secondaryOutcomes': [{'measure': 'Neurological outcome with the Glasgow Coma Scale (GCS) score', 'timeFrame': 'at day 0'}, {'measure': 'Neurological outcome with the Glasgow Coma Scale (GCS) score', 'timeFrame': 'at 6 months'}, {'measure': 'Neurological outcome with the Glasgow Coma Scale (GCS) score', 'timeFrame': 'at 12 months'}, {'measure': 'Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score', 'timeFrame': 'at day 0'}, {'measure': 'Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score', 'timeFrame': 'at 6 months'}, {'measure': 'Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score', 'timeFrame': 'at 12 months'}, {'measure': 'Brain lesions with MRI', 'timeFrame': 'at day 0'}, {'measure': 'Brain lesions with MRI', 'timeFrame': 'at 6 months'}, {'measure': 'Brain lesions with MRI', 'timeFrame': 'at 12 months'}, {'measure': 'delay of apparition of hyponatremia', 'timeFrame': 'on alternte days after Day 0', 'description': 'Natremia in standard blood sample, Natremia is routinelly evaluated on alternte days, and more if required.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Subarachnoid Hemorrhage', 'Neurointensive care', 'Observational registry'], 'conditions': ['Subarachnoid Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '39448701', 'type': 'DERIVED', 'citation': 'Chardon N, Nourredine M, Ledochowski S, Kurland NT, Dailler F, Ritzenthaler T, Nougier C, Balanca B. Trajectory of mean platelet volume changes after aneurysmal subarachnoid hemorrhage in patients with or without delayed cerebral ischemia. Sci Rep. 2024 Oct 24;14(1):25122. doi: 10.1038/s41598-024-75587-8.'}]}, 'descriptionModule': {'briefSummary': 'This prospective, observational study aim to identify :\n\n* Prognostic factor of patients with subarachnoid haemorrhage in neuro intensive care unit\n* The impact of standard therapeutic used (surgery, embolization ; medical treatment of vasospasm ; treatment of complications like hyponatremia, stress myocardiopathy, …)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted to the unit of investigator with subarachnoid hemorrhage, whatever the etiology, is included in their prospective registry', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subarachnoid hemorrhage\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02890004', 'acronym': 'ProReSHA', 'briefTitle': 'Observational Study of Patients With Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'A Prospective, Observational Registry of Patient With Subarachnoid Hemorrhage in Neurocritical Care Unit', 'orgStudyIdInfo': {'id': '69HCL16_0561'}}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frédéric DAILLER, MD', 'role': 'CONTACT', 'email': 'frederic.dailler@chu-lyon.fr', 'phone': '472 35 75 76', 'phoneExt': '+33'}, {'name': 'Frédéric DAILLER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de réanimation polyvalente neurologique Hôpital Neurologique HCL', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'centralContacts': [{'name': 'Frédéric DAILLER, MD', 'role': 'CONTACT', 'email': 'frederic.dailler@chu-lyon.fr', 'phone': '4 72 35 75 76', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Frédéric DAILLER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de réanimation neurologique Hospices Civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}