Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT00787020
Status:
COMPLETED
Last Update Posted:
2015-11-03
First Post:
2008-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Ventriculostomies in SAH: ICP Open or Not?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Olson006@mc.duke.edu', 'phone': '9196683751', 'title': 'DaiWai M Olson', 'organization': 'Duke University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ventriculostomy Open', 'description': 'Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ventriculostomy Monitored', 'description': 'Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.', 'otherNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cerebral Artery Vasospasm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ventriculostomy Open', 'description': 'Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.'}, {'id': 'OG001', 'title': 'Ventriculostomy Monitored', 'description': 'Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 days', 'description': 'Cerebral artery vasospasm is defined as transcranial doppler mean velocity greater than 120 or angiographic vasospasm determined by cerebral angiogram.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'External Ventricular Drain (EVD) Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ventriculostomy Open', 'description': 'Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.'}, {'id': 'OG001', 'title': 'Ventriculostomy Monitored', 'description': 'Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '14 Days', 'description': 'External ventricular drain complications are defined as ventriculitis, shunt dependency, ventricular catheter obstruction requiring manipulation, or removal by the patient.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cerebrospinal Fluid (CSF) Output Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ventriculostomy Open', 'description': 'Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.'}, {'id': 'OG001', 'title': 'Ventriculostomy Monitored', 'description': 'Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000', 'lowerLimit': '116.9', 'upperLimit': '151.1'}, {'value': '135', 'groupId': 'OG001', 'lowerLimit': '112.2', 'upperLimit': '157.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': '14 Days', 'unitOfMeasure': 'Milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ventriculostomy Open', 'description': 'Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.'}, {'id': 'FG001', 'title': 'Ventriculostomy Monitored', 'description': 'Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ventriculostomy Open', 'description': 'Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.'}, {'id': 'BG001', 'title': 'Ventriculostomy Monitored', 'description': 'Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.92', 'spread': '13.35', 'groupId': 'BG000'}, {'value': '53.13', 'spread': '11.13', 'groupId': 'BG001'}, {'value': '54.11', 'spread': '11.85', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-11', 'studyFirstSubmitDate': '2008-11-06', 'resultsFirstSubmitDate': '2010-10-06', 'studyFirstSubmitQcDate': '2008-11-06', 'lastUpdatePostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-22', 'studyFirstPostDateStruct': {'date': '2008-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral Artery Vasospasm', 'timeFrame': '14 days', 'description': 'Cerebral artery vasospasm is defined as transcranial doppler mean velocity greater than 120 or angiographic vasospasm determined by cerebral angiogram.'}], 'secondaryOutcomes': [{'measure': 'External Ventricular Drain (EVD) Complications', 'timeFrame': '14 Days', 'description': 'External ventricular drain complications are defined as ventriculitis, shunt dependency, ventricular catheter obstruction requiring manipulation, or removal by the patient.'}, {'measure': 'Cerebrospinal Fluid (CSF) Output Per Day', 'timeFrame': '14 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cerebrospinal Fluid', 'Ventriculostomy', 'Subarachnoid hemorrhage', 'vasospasm', 'Human Subjects'], 'conditions': ['Subarachnoid Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '20596794', 'type': 'RESULT', 'citation': 'Kim GS, Amato A, James ML, Britz GW, Zomorodi A, Graffagnino C, Zomorodi M, Olson DM. Continuous and intermittent CSF diversion after subarachnoid hemorrhage: a pilot study. Neurocrit Care. 2011 Feb;14(1):68-72. doi: 10.1007/s12028-010-9401-y.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is explore how cerebrospinal fluid (CSF) drainage impacts outcomes for patients diagnosed with subarachnoid hemorrhage (SAH). This is a non-randomized observational study of two physician-prescribed approaches to managing intracranial pressure monitoring and CSF drainage for SAH patients. The study will enroll only those patients who have intracranial pressure (ICP) monitoring in situ. Because this is an observational study, there are no physical risks to the patient, the only risk is loss of confidentiality.', 'detailedDescription': "There are no interventions specific to this observational study. The nurses and physicians who care for subjects in the study are already competent in the care and management of patients with subarachnoid hemorrhage (SAH) and intracranial pressure (ICP) monitoring as a requirement of their current employment at Duke University. Patients with confirmed diagnosis of subarachnoid hemorrhage requiring ICP and CSF management will be admitted to the 16 bed Neurocritical Care Unit (NCCU) at Duke Hospital. After admission procedures and a baseline neurologic assessment are complete, the charge nurse or NCCU fellow will notify an investigator of subjects meeting inclusion criteria. The investigator or research coordinator for this project will complete a review preparatory to research (RPR) to ensure no exclusion criteria are present and once subject appropriateness has been confirmed patients and their families will be introduced to the investigator for the purpose of obtaining informed consent. The subject's legally authorized representative (LAR) will be informed of the study's purpose, risks and benefits, and the rights of research subjects.\n\nData will be collected that reflects the duration of the patient's hospitalization at Duke University through chart abstraction. The study period will be defined as admission to discharge. The attending physician has, and will continue to, determine the appropriateness of the duration of ICP monitoring, NCCU discharge criteria and hospital discharge criteria. Chart abstraction will be completed daily to obtain the ICP values and CSF volumes during that period of time for which the patient has a ventriculostomy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subarachnoid hemorrhage', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of subarachnoid hemorrhage\n* Age 18 years or older\n* Ventriculostomy in situ\n\nExclusion Criteria:\n\n* Prisoners\n* Glasgow coma score = 3'}, 'identificationModule': {'nctId': 'NCT00787020', 'acronym': 'VISION', 'briefTitle': 'Ventriculostomies in SAH: ICP Open or Not?', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Ventriculostomies in SAH: ICP Open or Not?', 'orgStudyIdInfo': {'id': 'Pro00005900'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ventriculostomy Open', 'description': 'Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by positioning the stopcock in the open position and the intracranial pressure (ICP) is monitored once each hour: CSF drains into an external ventricular drainage bag.'}, {'label': 'Ventriculostomy Monitored', 'description': 'Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'DaiWai M Olson, PhD RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}