SAH Clinical Trial
Official title:
Atorvastatin Effect in Incidence and Ischemic Complications of Vasospasm After Subarachnoid Aneurysmal Hemorrhage: a Cohort Study
The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, known as statins, have recently been demonstrated to improve endothelial function. Additionally, numerous studies have shown statins as having antiinflammatory and cell-signaling effects together with a selective up-regulation of the eNOS activity. These findings are of potential benefit for the prevention of cerebral vasospasm after a aneurysmal subarachnoid hemorrhage. Indeed, one of the possible mechanisms for this vasospasm is the eNOS depletion or even increase of eNOS expression after the hemorrhage. The purpose of this study is to observe the immediate effect of statins after aneurysmal subarachnoid hemorrhage (aSAH) in cerebral vasospasm and outcome at one year.
Status | Completed |
Enrollment | 278 |
Est. completion date | December 2007 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 80 Years |
Eligibility |
Inclusion Criteria: - SAH patient > 16 years-old admitted to the Pitie- Salpetriere Teaching Hospital - Securing procedure within 96 hours of bleeding Exclusion Criteria: - Securing procedure > 96 hours of bleeding - Rebleeding of original aneurysm |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier Pitie-Salpetriere |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | S100B assay measured daily from days 1-15 | Day 1 through 15 | No | |
Secondary | Ischemic lesion volume | Ischemic lesion voulume was measured on the last available CT prior to death or hospital discharge | admission upon death or hospital discharge | No |
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