Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 194 for:    Hemorrhage AND SAH

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02350335
Recruitment Status : Completed
First Posted : January 29, 2015
Last Update Posted : April 12, 2016
Sponsor:
Information provided by (Responsible Party):
Angelika Sorteberg, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Aneurysmal Subarachnoid Hemorrhage Drug: Nicotine (transdermal) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage
Study Start Date : January 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: NRT

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)
Application of transdermal nicotine replacement in smokers with acute aneurysmal hemorrhage
Other Name: Nicotinelle

No Intervention: no NRT
Active smokers with acute aneurysmal hemorrhage that were assigned to not receive transdermal nicotine replacement.
No Intervention: non-smokers
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350335


Locations
Layout table for location information
Norway
Oslo University Hospital
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Angelika G Sorteberg, MD, PhD Consulting neurosurgeon, Head of division Rikshospitalet

Publications:
Layout table for additonal information
Responsible Party: Angelika Sorteberg, Md, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02350335     History of Changes
Other Study ID Numbers: 2011-2561b
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Angelika Sorteberg, Oslo University Hospital:
aneurysm
nicotine replacement therapy
cerebral vasospasm
outcome

Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Subarachnoid Hemorrhage
Intracranial Hemorrhages
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action