Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage (NRT-SAH)
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|ClinicalTrials.gov Identifier: NCT02350335|
Recruitment Status : Completed
First Posted : January 29, 2015
Last Update Posted : April 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Aneurysmal Subarachnoid Hemorrhage||Drug: Nicotine (transdermal)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
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
Drug: Nicotine (transdermal)
Application of transdermal nicotine replacement in smokers with acute aneurysmal hemorrhage
Other Name: Nicotinelle
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.
- 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.
- Smoking status [ Time Frame: 1 year ]Managed to quit smoking after NRT?
- Functional outcome [ Time Frame: 3 and 12 months ]Glasgow outcome scale, Glasgow outcome scale extended, Rankin Stroke Scale, return to work
- Drug consumption [ Time Frame: as long as the patient is in the intensive care unit ]Use of sedatives and anesthetics
- 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)
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350335
|Oslo University Hospital|
|Oslo, Norway, 0027|
|Principal Investigator:||Angelika G Sorteberg, MD, PhD||Consulting neurosurgeon, Head of division Rikshospitalet|