Aneurysmal Subarachnoid Hemorrhage
Conditions
Keywords
aneurysm, nicotine replacement therapy, cerebral vasospasm, outcome
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.
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.
Interventions
DRUGNicotine (transdermal)
Application of transdermal nicotine replacement in smokers with acute aneurysmal hemorrhage
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Norway
Outcome results
None listed