ICP Versus Intracranial Compliance Guided Management in SAH
This study has been completed.
Sponsor:
Oslo University Hospital
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00248690
First received: October 25, 2005
Last updated: January 17, 2011
Last verified: January 2008
| Tracking Information | |||||
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| First Received Date ICMJE | October 25, 2005 | ||||
| Last Updated Date | January 17, 2011 | ||||
| Start Date ICMJE | November 2005 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
All cause mortality and neurological outcome [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
All cause mortality and neurological outcome at 3 and 12 months. | ||||
| Change History | Complete list of historical versions of study NCT00248690 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE |
Length of stay (ICU, hospital); complications; effect of treatment modalities on mean ICP, CPP, ICP mean wave amplitude. | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | ICP Versus Intracranial Compliance Guided Management in SAH | ||||
| Official Title ICMJE | Intracranial Pressure (ICP) Versus Intracranial Compliance (ICC) Guided Management in Subarachnoid Hemorrhage; - a Prospective, Randomized Trial. | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) |
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| Condition ICMJE | Subarachnoid Hemorrhage (SAH) | ||||
| Intervention ICMJE | Device: ICP mean wave amplitude
Appropriate measures when ICP mean wave amplitude is to high, e.g. CSF drainage |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Eide PK, Sorteberg A, Bentsen G, Marthinsen PB, Stubhaug A, Sorteberg W. Pressure-derived versus pressure wave amplitude-derived indices of cerebrovascular pressure reactivity in relation to early clinical state and 12-month outcome following aneurysmal subarachnoid hemorrhage. J Neurosurg. 2012 May;116(5):961-71. Epub 2012 Feb 10. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 100 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00248690 | ||||
| Other Study ID Numbers ICMJE | 2005-SAHD, S-05184 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Audun Stubhaug / Professor, Rikshospitalet-Radiumhospitalet HF | ||||
| Study Sponsor ICMJE | Oslo University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Oslo University Hospital | ||||
| Verification Date | January 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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