ICP Versus Intracranial Compliance Guided Management in SAH
The purpose of this study is to determine whether treatment guided also by ICP mean wave amplitude improves outcome compared to international standard care in patients with SAH.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
|Official Title:||Intracranial Pressure (ICP) Versus Intracranial Compliance (ICC) Guided Management in Subarachnoid Hemorrhage; - a Prospective, Randomized Trial.|
- All cause mortality and neurological outcome [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
- Length of stay (ICU, hospital); complications; effect of treatment modalities on mean ICP, CPP, ICP mean wave amplitude. [ Time Frame: Hospital stay ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2005|
|Study Completion Date:||June 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Device: ICP mean wave amplitude
In this study SAH-patients are randomized to treatment based on international standard care (ICP/CPP guided therapy) or intracranial compliance (ICP mean wave amplitude) guided therapy in addition to ICP/CPP guided therapy. Main outcome variables are survival and neurological outcome after 3 and 12 months.