An interventional study of Nicotine (transdermal) in Aneurysmal Subarachnoid Hemorrhage, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-12.
Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment
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.
Various aspects of the study:
509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.
This study's enrollment of 200 is above the median of 52 across 263 interventional studies indexed under Subarachnoid Hemorrhage.
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Exclusion Criteria:
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
Drug: Nicotine (transdermal)
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.
Application of transdermal nicotine replacement in smokers with acute aneurysmal hemorrhage
Also known as: Nicotinelle
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.
Time frame: 21 days
Smoking status
Managed to quit smoking after NRT?
Time frame: 1 year
Functional outcome
Glasgow outcome scale, Glasgow outcome scale extended, Rankin Stroke Scale, return to work
Time frame: 3 and 12 months
Drug consumption
Use of sedatives and anesthetics
Time frame: as long as the patient is in the intensive care unit
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)
Time frame: 3-6 months
Complications
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
Plan to share: No
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Oslo University Hospital