ICP Versus Intracranial Compliance Guided Management in SAH

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00248690
First received: October 25, 2005
Last updated: January 17, 2011
Last verified: January 2008

October 25, 2005
January 17, 2011
November 2005
February 2009   (final data collection date for primary outcome measure)
All cause mortality and neurological outcome [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
All cause mortality and neurological outcome at 3 and 12 months.
Complete list of historical versions of study NCT00248690 on ClinicalTrials.gov Archive Site
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 ]
Length of stay (ICU, hospital); complications; effect of treatment modalities on mean ICP, CPP, ICP mean wave amplitude.
Not Provided
Not Provided
 
ICP Versus Intracranial Compliance Guided Management in SAH
Intracranial Pressure (ICP) Versus Intracranial Compliance (ICC) Guided Management in Subarachnoid Hemorrhage; - a Prospective, Randomized Trial.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Subarachnoid Hemorrhage (SAH)
Device: ICP mean wave amplitude
Appropriate measures when ICP mean wave amplitude is to high, e.g. CSF drainage
Not Provided
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. doi: 10.3171/2012.1.JNS111313. Epub 2012 Feb 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
June 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subarachnoid hemorrhage, acute
  • Intracerebral pressure monitoring device inserted

Exclusion criteria:

  • No intracranial pressure monitoring
  • Age < 18 years
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00248690
2005-SAHD, S-05184
Not Provided
Audun Stubhaug / Professor, Rikshospitalet-Radiumhospitalet HF
Oslo University Hospital
Not Provided
Study Director: Gunnar Bentsen, MD Oslo University Hospital
Oslo University Hospital
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP