Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage
NCT ID: NCT02350335
Last Updated: 2016-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2011-01-31
2015-12-31
Brief Summary
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Detailed Description
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* Study cerebral circulation with transcranial Doppler ultrasonography (TCD) prior to and after NRT.
* Study cardiac output and peripheral vessel resistance minimally invasive (LiDCO) prior to and after NRT in patients that already have established LiDCO.
* Monitor intracranial pressure prior to and after NRT in patients that have established an intracranial pressure sensor.
* Register the frequency of cerebral vasospasm and complications in non-smokers, smokers without NRT, and smokers with NRT.
* Register the use of opioids, opioidanesthetics, propofol og psycholeptics in non-smokers, smokers without NRT, and smokers with NRT.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NRT
Active smokers with acute aneurysmal hemorrhage randomly assigned to transdermal nicotine replacement after securing of the aneurysm.
Patient management for all patients is according to the institutional treatment guidelines and independent of group assignment.
The 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
Nicotine (transdermal)
Application of transdermal nicotine replacement in smokers with acute aneurysmal hemorrhage
no NRT
Active smokers with acute aneurysmal hemorrhage that were assigned to not receive transdermal nicotine replacement.
No interventions assigned to this group
non-smokers
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.
No interventions assigned to this group
Interventions
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Nicotine (transdermal)
Application of transdermal nicotine replacement in smokers with acute aneurysmal hemorrhage
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Angelika Sorteberg
Md, PhD
Principal Investigators
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Angelika G Sorteberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Consulting neurosurgeon, Head of division Rikshospitalet
Locations
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Oslo University Hospital
Oslo, Oslo County, Norway
Countries
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References
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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.
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.
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.
Other Identifiers
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2011-2561b
Identifier Type: -
Identifier Source: org_study_id
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