Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Cerebral vasospasm
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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
Intervention: Nicotine (transdermal) (Drug)
Outcomes
Primary Outcomes
Cerebral vasospasm
Time Frame: 21 days
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.
Secondary Outcomes
- Drug consumption(as long as the patient is in the intensive care unit)
- Cerebral infarction(3-6 months)
- Complications(3-6 months)
- Functional outcome(3 and 12 months)
- Smoking status(1 year)
Investigators
Angelika Sorteberg
Md, PhD
Oslo University Hospital