Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-05 @ 6:30 PM
Study NCT ID:
NCT02350335
Status:
COMPLETED
Last Update Posted:
2016-04-12
First Post:
2015-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D020301', 'term': 'Vasospasm, Intracranial'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009538', 'term': 'Nicotine'}, {'id': 'D000279', 'term': 'Administration, Cutaneous'}], 'ancestors': [{'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D000287', 'term': 'Administration, Topical'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-11', 'studyFirstSubmitDate': '2015-01-12', 'studyFirstSubmitQcDate': '2015-01-25', 'lastUpdatePostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral vasospasm', 'timeFrame': '21 days', 'description': 'Frequency of cerebral vasospasm within 21 days after the ictus. The institutional protocol for management of aneurysmal hemorrhage is followed in diagnosing cerebral vasospasm. This includes monitoring for cerebral vasospasm with transcranial Doppler ultrasonography and a cerebral computed tomography angiogram on day 7 after the ictus. Digital subtraction angiography is performed when necessary. All patients are monitored in the intensive care or intermediate care unit for clinical signs of cerebral vasospasm.'}], 'secondaryOutcomes': [{'measure': 'Smoking status', 'timeFrame': '1 year', 'description': 'Managed to quit smoking after NRT?'}, {'measure': 'Functional outcome', 'timeFrame': '3 and 12 months', 'description': 'Glasgow outcome scale, Glasgow outcome scale extended, Rankin Stroke Scale, return to work'}, {'measure': 'Drug consumption', 'timeFrame': 'as long as the patient is in the intensive care unit', 'description': 'Use of sedatives and anesthetics'}, {'measure': 'Cerebral infarction', 'timeFrame': '3-6 months', 'description': 'Radiological evidence of irreversible brain tissue damage. All patients have a control scan approximately 3 months after the ictus. This is either a computed tomography scan (if the patient had the aneurysm secured surgically) or a magnetic resonance image (if the patient had endovascular repair of the aneurysm)'}, {'measure': 'Complications', 'timeFrame': '3-6 months', 'description': 'Frequency of complications including secondary hydrocephalus and mortality. Special emphasis on thrombo-embolic complications (deep venous thrombosis and pulmonary embolism)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['aneurysm', 'nicotine replacement therapy', 'cerebral vasospasm', 'outcome'], 'conditions': ['Aneurysmal Subarachnoid Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '20949331', 'type': 'BACKGROUND', 'citation': 'Seder DB, Schmidt JM, Badjatia N, Fernandez L, Rincon F, Claassen J, Gordon E, Carrera E, Kurtz P, Lee K, Connolly ES, Mayer SA. Transdermal nicotine replacement therapy in cigarette smokers with acute subarachnoid hemorrhage. Neurocrit Care. 2011 Feb;14(1):77-83. doi: 10.1007/s12028-010-9456-9.'}, {'pmid': '17881958', 'type': 'BACKGROUND', 'citation': 'Krishnamurthy S, Kelleher JP, Lehman EB, Cockroft KM. Effects of tobacco dose and length of exposure on delayed neurological deterioration and overall clinical outcome after aneurysmal subarachnoid hemorrhage. Neurosurgery. 2007 Sep;61(3):475-80; discussion 480-1. doi: 10.1227/01.NEU.0000290892.46954.12.'}, {'pmid': '9724114', 'type': 'BACKGROUND', 'citation': 'Weir BK, Kongable GL, Kassell NF, Schultz JR, Truskowski LL, Sigrest A. Cigarette smoking as a cause of aneurysmal subarachnoid hemorrhage and risk for vasospasm: a report of the Cooperative Aneurysm Study. J Neurosurg. 1998 Sep;89(3):405-11. doi: 10.3171/jns.1998.89.3.0405.'}]}, 'descriptionModule': {'briefSummary': 'All patients with acute aneurysmal hemorrhage are treated in accordance with our institutional protocol. After securing of the aneurysm, some smokers with acute aneurysmal hemorrhage are randomly assigned to transdermal nicotine replacement (NRT). The short- and long-term effect of NRT will be studied comparing non-smokers, smokers without NRT and smokers with NRT.', 'detailedDescription': 'Various aspects of the study:\n\n* Study cerebral circulation with transcranial Doppler ultrasonography (TCD) prior to and after NRT.\n* Study cardiac output and peripheral vessel resistance minimally invasive (LiDCO) prior to and after NRT in patients that already have established LiDCO.\n* Monitor intracranial pressure prior to and after NRT in patients that have established an intracranial pressure sensor.\n* Register the frequency of cerebral vasospasm and complications in non-smokers, smokers without NRT, and smokers with NRT.\n* Register the use of opioids, opioidanesthetics, propofol og psycholeptics in non-smokers, smokers without NRT, and smokers with NRT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aneurysmal subarachnoid hemorrhage after securing of the aneurysm and surviving the first 2 weeks.\n\nExclusion Criteria:\n\n* manifest cerebral vasospasm at arrival at our department (i.e. before securing of the aneurysm)'}, 'identificationModule': {'nctId': 'NCT02350335', 'acronym': 'NRT-SAH', 'briefTitle': 'Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': '2011-2561b'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NRT', 'description': 'Active smokers with acute aneurysmal hemorrhage randomly assigned to transdermal nicotine replacement after securing of the aneurysm.\n\nPatient management for all patients is according to the institutional treatment guidelines and independent of group assignment.\n\nThe dose is dependent on smoke consumption prior to the ictus. Nicorette 7 mg/day for smokers smoking 1-10 cigarettes /day Nicorette 14mg/day for smokers smoking 11-19 cigarettes/day Nicorette 21 mg/day for smokers smoking 20 or more cigarettes daily', 'interventionNames': ['Drug: Nicotine (transdermal)']}, {'type': 'NO_INTERVENTION', 'label': 'no NRT', 'description': 'Active smokers with acute aneurysmal hemorrhage that were assigned to not receive transdermal nicotine replacement.'}, {'type': 'NO_INTERVENTION', 'label': 'non-smokers', 'description': 'Non-smokers with acute aneurysmal hemorrhage. Non-smokers do not receive transdermal nicotine replacement. This group is to be compared to the group of active smokers receiving transdermal nicotine replacement and to the group of active smokers not receiving transdermal nicotine replacement.'}], 'interventions': [{'name': 'Nicotine (transdermal)', 'type': 'DRUG', 'otherNames': ['Nicotinelle'], 'description': 'Application of transdermal nicotine replacement in smokers with acute aneurysmal hemorrhage', 'armGroupLabels': ['NRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0027', 'city': 'Oslo', 'state': 'Oslo County', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Angelika G Sorteberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consulting neurosurgeon, Head of division Rikshospitalet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Md, PhD', 'investigatorFullName': 'Angelika Sorteberg', 'investigatorAffiliation': 'Oslo University Hospital'}}}}