Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage

NCT02350335 | Completed

• 1 other identifier: 2011-2561b
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage

Keywords

aneurysm; nicotine replacement therapy; cerebral vasospasm; outcome

Outcome Measures

Primary Outcomes (1)

• 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.

  21 days

Secondary Outcomes (5)

• Smoking status

  1 year

• Functional outcome

  3 and 12 months

• Drug consumption

  as long as the patient is in the intensive care unit

• Cerebral infarction

  3-6 months

• Complications

  3-6 months

Study Arms (3)

NRT

ACTIVE COMPARATOR

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)

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.

Interventions

Nicotine (transdermal) DRUG

Application of transdermal nicotine replacement in smokers with acute aneurysmal hemorrhage

Also known as: Nicotinelle

NRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aneurysmal subarachnoid hemorrhage after securing of the aneurysm and surviving the first 2 weeks.

You may not qualify if:

• manifest cerebral vasospasm at arrival at our department (i.e. before securing of the aneurysm)

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0027, Norway

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Aneurysm; Vasospasm, Intracranial

Interventions

Nicotine; Administration, Cutaneous

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Administration, Topical; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Angelika G Sorteberg, MD, PhD

  Consulting neurosurgeon, Head of division Rikshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md, PhD

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 29, 2015
• Study Start: January 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 12, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)