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Completed

NCT Number: NCT02350335

Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0027, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nicotine (transdermal)

Drug

Application of transdermal nicotine replacement in smokers with acute aneurysmal hemorrhage

Other names: Nicotinelle

Primary outcomes

  1. 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.

Secondary outcomes

  1. Smoking status

    Time frame: 1 year

    Managed to quit smoking after NRT?

  2. Functional outcome

    Time frame: 3 and 12 months

    Glasgow outcome scale, Glasgow outcome scale extended, Rankin Stroke Scale, return to work

  3. Drug consumption

    Time frame: as long as the patient is in the intensive care unit

    Use of sedatives and anesthetics

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Acronym: NRT-SAH

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 29, 2015
Registry last updated
Apr 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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