Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-01-03 @ 10:20 PM
Study NCT ID:
NCT00593268
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-07
First Post:
2008-01-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Cerebral Spinal Fluid and Blood in 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'cerebrospinal fluid and blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2008-01-02', 'studyFirstSubmitQcDate': '2008-01-02', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlate biological markers of cerebral vasospasm with clinical outcomes', 'timeFrame': 'post hemorrhage', 'description': 'Correlation of blood biological markers and clinical outcomes of cerebral vasospasm'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Subarachnoid Hemorrhage']}, 'descriptionModule': {'briefSummary': 'In this project we are collecting cerebrospinal fluid and blood from patients at Vanderbilt Medical Center who have a subarachnoid hemorrhage which has followed the rupture of a brain aneurysm. We then propose to study the cerebrospinal fluid using a novel microscopic laser directed mass spectrometric analysis (MALDI) available at Vanderbilt. The cerebrospinal fluid and blood will then be analysed for different biological markers, protein expression and gene expression. These markers will then be statistically correlated with clinical data including prediction of vasospasm, time to vasospasm and response to standard therapy.', 'detailedDescription': 'In this project we are collecting cerebrospinal fluid and blood from patients at Vanderbilt Medical Center who have a subarachnoid hemorrhage which has followed the rupture of a brain aneurysm. We then propose to study the cerebrospinal fluid using a novel microscopic laser directed mass spectrometric analysis (MALDI) available at Vanderbilt. The cerebrospinal fluid and blood will then be analysed for different biological markers, protein expression and gene expression. These markers will then be statistically correlated with clinical data including prediction of vasospasm, time to vasospasm and response to standard therapy.\n\nThe goal of this study is to determine cerebrospinal fluid and serum markers which will be predictive of vasospasm. This in turn may lead to improved outcomes in this population of patients.\n\nThe data will be compared to excess cerebrospinal fluid collected from patients who are undergoing lumbar puncture in the Neurology Clinic or excess cerebrospinal fluid from patients undergoing cranial surgery for other causes like tumor excision.\n\nFor patients enrolled in the study, cerebrospinal fluid will be collected by either lumbar puncture or external ventricular catheter. Specimens will be collected immediately pre-operatively if an external ventricular drain is in place or intraoperatively if an external ventricular drain is not present. We will also collect cerebrospinal fluid post operatively after placement of an external ventricular drain regularly from the excess cerebrospinal fluid that has been collected in the drainage bag. CSF will be collected in a serial fashion at multiple time points: immediately post operatively, during vasospasm and before the external ventricular drain is removed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '18 years of age or older', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients eligible to participate in this study are those that have a documented subarachnoid hemorrhage from a ruptured cerebral aneurysm or patients who have excess cerebrospinal fluid after a Lumbar Puncture or surgery for tumor resection.\n* 18 years of age or older\n\nExclusion Criteria:\n\n* Patients or family who are unable to understand the informed consent process will be excluded.'}, 'identificationModule': {'nctId': 'NCT00593268', 'briefTitle': 'Evaluation of Cerebral Spinal Fluid and Blood in Patients With Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Biological Markers of Vasospasm in Cerebral Spinal Fluid and Blood in Patients With Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': '031084'}}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center, Department of Neurological Surgery', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Reid C. Thomspon, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center, Department of Neurological Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurological Surgery', 'investigatorFullName': 'Reid Thompson', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}