In patients with aneurysmal subarachnoid hemorrhage simvastatin restores endothelial cell damage, activates fibrinolysis, and improves coagulation and inflammation after the hemorrhage.
ID
Bron
Verkorte titel
Aandoening
aneurysmal subarachnoid hemorrhage
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. The effects of simvastatin on parameters of fibrinolysis, coagulation, inflammation and endothelial function after SAH;<br>
2. The relation between changes in fibrinolytic activity and endothelial cell damage and activation.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
In patients with aneurysmal subarachnoid hemorrhage simvastatin restores endothelial cell damage, activates fibrinolysis, and improves coagulation and inflammation after the hemorrhage.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Patients will receive simvastatin 80 mg a day or placebo until day 14 after aneurysmal subarachnoid hemorrhage.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL610 |
| NTR-old | NTR668 |
| Ander register | : N/A |
| ISRCTN | ISRCTN45662651 |