Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage

NCT02350335 — Not applicable, Completed, 200 participants, Oslo University Hospital

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Registry	NCT02350335, acronym NRT-SAH
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	200 (Actual)
Sponsor	Oslo University Hospital (Other)
Conditions	Aneurysmal Subarachnoid Hemorrhage
Interventions	Nicotine (transdermal) (Drug)
Dates	start 2011-01-01, primary completion 2015-12-01, completion 2015-12-01, first posted 2015-01-29, last updated 2016-04-12
Locations	1 site in Norway

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
NRT	Active comparator	Drug: Nicotine (transdermal)	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
no NRT	No intervention		Active smokers with acute aneurysmal hemorrhage that were assigned to not receive transdermal nicotine replacement.
non-smokers	No intervention		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.

Nicotine (transdermal) (Drug), also known as Nicotinelle: Application of transdermal nicotine replacement in smokers with acute aneurysmal hemorrhage

+Outcome measures

Primary outcomes

Cerebral vasospasm [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.

Secondary outcomes

Smoking status [1 year]: Managed to quit smoking after NRT?
Functional outcome [3 and 12 months]: Glasgow outcome scale, Glasgow outcome scale extended, Rankin Stroke Scale, return to work
Drug consumption [as long as the patient is in the intensive care unit]: Use of sedatives and anesthetics
Cerebral infarction [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 [3-6 months]: Frequency of complications including secondary hydrocephalus and mortality. Special emphasis on thrombo-embolic complications (deep venous thrombosis and pulmonary embolism)

+Eligibility

Sex: All, ages: 18 Years to any

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)

+Locations (1)

Facility	City	Country	Status
Oslo University Hospital	Oslo, Oslo	Norway

+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. PMID 20949331
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. PMID 17881958
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. PMID 9724114

+Investigators

Angelika G Sorteberg, MD, PhD, Principal investigator, Consulting neurosurgeon, Head of division Rikshospitalet