Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage (NRT-SAH)
April 11, 2016 updated by: Angelika Sorteberg, Oslo University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Oslo, Norway, 0027
- Oslo University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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 |
Application of transdermal nicotine replacement in smokers with acute aneurysmal hemorrhage
Other Names:
|
|
No Intervention: no NRT
Active smokers with acute aneurysmal hemorrhage that were assigned to not receive transdermal nicotine replacement.
|
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Smoking status
Time Frame: 1 year
|
Managed to quit smoking after NRT?
|
1 year
|
|
Functional outcome
Time Frame: 3 and 12 months
|
Glasgow outcome scale, Glasgow outcome scale extended, Rankin Stroke Scale, return to work
|
3 and 12 months
|
|
Drug consumption
Time Frame: as long as the patient is in the intensive care unit
|
Use of sedatives and anesthetics
|
as long as the patient is in the intensive care unit
|
|
Cerebral infarction
Time Frame: 3-6 months
|
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)
|
3-6 months
|
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Complications
Time Frame: 3-6 months
|
Frequency of complications including secondary hydrocephalus and mortality.
Special emphasis on thrombo-embolic complications (deep venous thrombosis and pulmonary embolism)
|
3-6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Angelika G Sorteberg, MD, PhD, Consulting neurosurgeon, Head of division Rikshospitalet
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
January 12, 2015
First Submitted That Met QC Criteria
January 25, 2015
First Posted (Estimate)
January 29, 2015
Study Record Updates
Last Update Posted (Estimate)
April 12, 2016
Last Update Submitted That Met QC Criteria
April 11, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Intracranial Hemorrhages
- Hemorrhage
- Subarachnoid Hemorrhage
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- 2011-2561b
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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