Effect of simvastatin on endothelial dysfunction, fibrinolysis, coagulation and inflammation after aneurysmal subarachnoid hemorrhage.
Completed
- Conditions
- aneurysmal subarachnoid hemorrhage
- Registration Number
- NL-OMON28808
- Lead Sponsor
- Academic Medical Center (AMC), Department of Neurology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Patients with clinical symptoms and signs of SAH with an aneurysmal bleeding pattern on the initial CT scan. CT scan has to be performed within 48 hours after SAH onset;
2. Patients with a perimesencephalic hemorrhage pattern on the initial CT scan while CTA or conventional angiography has shown an appropriate aneurysm. CTA or angiography has to be performed within 48 hours after SAH onset;
Exclusion Criteria
1. Under 18 years of age;
2. A time lapse of more than 48 hours after SAH onset;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The effects of simvastatin on parameters of fibrinolysis, coagulation, inflammation and endothelial function after SAH;<br /><br>2. The relation between changes in fibrinolytic activity and endothelial cell damage and activation.
- Secondary Outcome Measures
Name Time Method 1. The occurrence of cerebral ischemia after SAH; <br /><br>2. Outcome on the Glasgow Outcome Scale and AMC Linear Disability Scale (ALDS) 3 and 6 months after subarachnoid hemorrhage; <br /><br>3. The relation between vasospasm as observed on Transcranial Doppler examination and parameters of fibrinolysis, coagulation, endothelium dysfunction and inflammation;<br /><br>4. The relation between cerebral ischemia as observed on perfusion CT-scans and <br>parameters of fibrinolysis, coagulation, endothelium dysfunction and inflammation;<br /><br>5. The relation of PAI-1 polymorphism on fibrinolysis in patients treated with simvastatin and placebo;<br /><br>6. The relation of polymorphisms in the endothelin system on endothelial cell damage;<br /><br>7. Differences in cerebral microcirculation between patients treated with placebo and <br>simvastatin.