Clinical trial NCT02350335: Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage
Official title: Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aneurysmal Subarachnoid Hemorrhage
Keywords: aneurysm
nicotine replacement therapy
cerebral vasospasm
outcome
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Various aspects of the study:

* 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.

Eligibility criteria: Inclusion Criteria:

* aneurysmal subarachnoid hemorrhage after securing of the aneurysm and surviving the first 2 weeks.

Exclusion Criteria:

* manifest cerebral vasospasm at arrival at our department (i.e. before securing of the aneurysm)

Primary outcomes:
measure: Cerebral vasospasm
timeFrame: 21 days
Secondary outcomes:
measure: Smoking status
timeFrame: 1 year
measure: Functional outcome
timeFrame: 3 and 12 months
measure: Drug consumption
timeFrame: as long as the patient is in the intensive care unit
measure: Cerebral infarction
timeFrame: 3-6 months
measure: Complications
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Consulting neurosurgeon, Head of division Rikshospitalet
name: Angelika G Sorteberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.