Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

— NRT-SAH  

Official title:

Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350335
• Other study ID #: 2011-2561b
• Status: Completed
• Phase: N/A
• First received: January 12, 2015
• Last updated: April 11, 2016
• Start date: January 2011
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Drug:
• Nicotine (transdermal)
Application of transdermal nicotine replacement in smokers with acute aneurysmal hemorrhage

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Smoking status	Managed to quit smoking after NRT?	1 year	No
Secondary	Functional outcome	Glasgow outcome scale, Glasgow outcome scale extended, Rankin Stroke Scale, return to work	3 and 12 months	No
Secondary	Drug consumption	Use of sedatives and anesthetics	as long as the patient is in the intensive care unit	No
Secondary	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)	3-6 months	No
Secondary	Complications	Frequency of complications including secondary hydrocephalus and mortality. Special emphasis on thrombo-embolic complications (deep venous thrombosis and pulmonary embolism)	3-6 months	No