Back to resultsTransdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage (NRT-SAH)
Primary Purpose
Aneurysmal Subarachnoid Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Nicotine (transdermal)
Sponsored by
About this trial
This is an interventional treatment trial for Aneurysmal Subarachnoid Hemorrhage focused on measuring aneurysm, nicotine replacement therapy, cerebral vasospasm, outcome
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)
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
No Intervention
No Intervention
Arm Label
NRT
no NRT
non-smokers
Arm Description
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
Active smokers with acute aneurysmal hemorrhage that were assigned to not receive transdermal nicotine replacement.
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.
Outcomes
Primary Outcome Measures
Cerebral vasospasm
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 Outcome Measures
Smoking status
Managed to quit smoking after NRT?
Functional outcome
Glasgow outcome scale, Glasgow outcome scale extended, Rankin Stroke Scale, return to work
Drug consumption
Use of sedatives and anesthetics
Cerebral infarction
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)
Complications
Frequency of complications including secondary hydrocephalus and mortality. Special emphasis on thrombo-embolic complications (deep venous thrombosis and pulmonary embolism)
Full Information
NCT ID
NCT02350335
First Posted
January 12, 2015
Last Updated
April 11, 2016
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02350335
Brief Title
Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage
Acronym
NRT-SAH
Official Title
Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysmal Subarachnoid Hemorrhage
Keywords
aneurysm, nicotine replacement therapy, cerebral vasospasm, outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NRT
Arm Type
Active Comparator
Arm Description
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
Arm Title
no NRT
Arm Type
No Intervention
Arm Description
Active smokers with acute aneurysmal hemorrhage that were assigned to not receive transdermal nicotine replacement.
Arm Title
non-smokers
Arm Type
No Intervention
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Nicotine (transdermal)
Other Intervention Name(s)
Nicotinelle
Intervention Description
Application of transdermal nicotine replacement in smokers with acute aneurysmal hemorrhage
Primary Outcome Measure Information:
Title
Cerebral vasospasm
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.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Smoking status
Description
Managed to quit smoking after NRT?
Time Frame
1 year
Title
Functional outcome
Description
Glasgow outcome scale, Glasgow outcome scale extended, Rankin Stroke Scale, return to work
Time Frame
3 and 12 months
Title
Drug consumption
Description
Use of sedatives and anesthetics
Time Frame
as long as the patient is in the intensive care unit
Title
Cerebral infarction
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)
Time Frame
3-6 months
Title
Complications
Description
Frequency of complications including secondary hydrocephalus and mortality. Special emphasis on thrombo-embolic complications (deep venous thrombosis and pulmonary embolism)
Time Frame
3-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelika G Sorteberg, MD, PhD
Organizational Affiliation
Consulting neurosurgeon, Head of division Rikshospitalet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0027
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20949331
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.
Results Reference
background
PubMed Identifier
17881958
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.
Results Reference
background
PubMed Identifier
9724114
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.
Results Reference
background
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Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage
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