No registrations found.
ID
Source
Brief title
Health condition
aneurysmal subarachnoid hemorrhage
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The effects of simvastatin on parameters of fibrinolysis, coagulation, inflammation and endothelial function after SAH;
2. The relation between changes in fibrinolytic activity and endothelial cell damage and activation.
Secondary outcome
1. The occurrence of cerebral ischemia after SAH;
2. Outcome on the Glasgow Outcome Scale and AMC Linear Disability Scale (ALDS) 3 and 6 months after subarachnoid hemorrhage;
3. The relation between vasospasm as observed on Transcranial Doppler examination and parameters of fibrinolysis, coagulation, endothelium dysfunction and inflammation;
4. The relation between cerebral ischemia as observed on perfusion CT-scans and
parameters of fibrinolysis, coagulation, endothelium dysfunction and inflammation;
5. The relation of PAI-1 polymorphism on fibrinolysis in patients treated with simvastatin and placebo;
6. The relation of polymorphisms in the endothelin system on endothelial cell damage;
7. Differences in cerebral microcirculation between patients treated with placebo and
simvastatin.
Background summary
Recently it has been observed that statins decrease the incidence of cerebral ischemia and vasospasm in patients with aneurysmal subarachnoid hemorrhage. This prospective, randomized, double-blind, placebo-controlled trial is an exploratory study designed to investigate the biological effects of simvastatin in patients with aneurysmal subarachnoid hemorrhage.
Study objective
In patients with aneurysmal subarachnoid hemorrhage simvastatin restores endothelial cell damage, activates fibrinolysis, and improves coagulation and inflammation after the hemorrhage.
Study design
N/A
Intervention
Patients will receive simvastatin 80 mg a day or placebo until day 14 after aneurysmal subarachnoid hemorrhage.
P.O. Box 22660
M.D.I. Vergouwen
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663842
m.d.vergouwen@amc.uva.nl
P.O. Box 22660
M.D.I. Vergouwen
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663842
m.d.vergouwen@amc.uva.nl
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;
3. If CT scan is negative while there is evidence of bleeding in the cerebrospinal fluid (xanthochromia) and the (CT-) angiography has shown an aneurysm.
Exclusion criteria
1. Under 18 years of age;
2. A time lapse of more than 48 hours after SAH onset;
3. Patients using aspirin or warfarin;
4. Patients already using statins;
5. Contra-indication for simvastatin (active liver disease, liver transaminase more than three times the normal upper limit, myopathy);
6. Kidney insufficiency;
7. If death appears imminent;
8. Pregnancy or lactation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL610 |
| NTR-old | NTR668 |
| Other | : N/A |
| ISRCTN | ISRCTN45662651 |