Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-03-03 @ 2:52 AM
Study NCT ID:
NCT01799018
Status:
COMPLETED
Last Update Posted:
2014-11-20
First Post:
2012-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Proteomics and Metallomics in Cerebral Vasospasm Following Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D020301', 'term': 'Vasospasm, Intracranial'}, {'id': 'D006849', 'term': 'Hydrocephalus'}], '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cerebrospinal Fluid (CSF)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-19', 'studyFirstSubmitDate': '2012-12-12', 'studyFirstSubmitQcDate': '2013-02-22', 'lastUpdatePostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Protein identification and concentration', 'timeFrame': 'For the duration of CSF drainage, or until the 21st day after admission.'}, {'measure': 'Metal ion identification and concentration', 'timeFrame': 'For the duration of CSF drainage, or until the 21st day after admission.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Xanthine Oxidase', 'Cerebrospinal fluid'], 'conditions': ['Subarachnoid Hemorrhage', 'Cerebral Vasospasm', 'Hydrocephalus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the role of Proteomics and Metallomics in Cerebral Vasospasm following Subarachnoid Hemorrhage'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non traumatic SAH documented by CT scan\n* Patient with SAH who would need external ventricular drain (EVD) for the management of hydrocephalus\n* Patients with normal pressure Hydrocephalus that require an external drain\n* Control (non - hemorrhagic) group - CSF collected from patients with posterior fossa tumor or stroke with EVD in place for the management of hydrocephalus.\n\nExclusion Criteria:\n\n* Recent infection within last 1 month of presentation- can increase inflammatory markers\n* Recent surgery or acute myocardial infarction within last 1 month of presentation\n* Age \\> 89 years or \\< 18 years'}, 'identificationModule': {'nctId': 'NCT01799018', 'briefTitle': 'Role of Proteomics and Metallomics in Cerebral Vasospasm Following Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York - Upstate Medical University'}, 'officialTitle': 'Role of Proteomics and Metallomics in Cerebral Vasospasm Following Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': 'IRB#225490'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SAH Patients', 'description': 'Patients admitted with the diagnosis of aneurismal subarachnoid hemorrhage (SAH) and cerebral angiogram negative SAH who would need to have the external ventricular drain (EVD) placed for the management of hydrocephalus.'}, {'label': 'Control Patients', 'description': 'Patients with non-hemorrhagic brain pathology such as posterior fossa tumor or stroke who will have the CSF sampling for diagnostic or therapeutic purposes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}], 'overallOfficials': [{'name': 'Eric M Deshaies, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SUNY Upstate Medical University - Neurosurgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York - Upstate Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}