Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage (NRT-SAH)

University of Oslo (UIO)

Status: Completed

Conditions: Aneurysmal Subarachnoid Hemorrhage

Treatments: Drug: Nicotine (transdermal)

Study type: Interventional

Funder types: Other

Identifiers

NCT02350335

2011-2561b

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

NRT

Active Comparator group

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

Treatment:

Drug: Nicotine (transdermal)

no NRT

No Intervention group

Description:

Active smokers with acute aneurysmal hemorrhage that were assigned to not receive transdermal nicotine replacement.

non-smokers

No Intervention group

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.