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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
History of Changes
  Purpose

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.


Condition Intervention
Subarachnoid Hemorrhage (SAH)
 Device: ICP mean wave amplitude

Study Type: Interventional
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • All cause mortality and neurological outcome [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: November 2005
Study Completion Date: June 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ICP mean wave amplitude
    Appropriate measures when ICP mean wave amplitude is to high, e.g. CSF drainage
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subarachnoid hemorrhage, acute
  • Intracerebral pressure monitoring device inserted

Exclusion criteria:

  • No intracranial pressure monitoring
  • Age < 18 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248690

Locations
Norway
Rikshospitalet University Hospital
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Director: Gunnar Bentsen, MD Oslo University Hospital
  More Information

No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Audun Stubhaug / Professor, Rikshospitalet-Radiumhospitalet HF
ClinicalTrials.gov Identifier: NCT00248690     History of Changes
Other Study ID Numbers: 2005-SAHD, S-05184
Study First Received: October 25, 2005
Last Updated: January 17, 2011
Health Authority: Norway: Norwegian Medicines Agency
Norway: The Data Inspectorate
Norway: Directorate of Health

Keywords provided by Oslo University Hospital:
Subarachnoid hemorrhage
Intracranial hypertension
Intracranial pressure
Diagnostic techniques and procedures
 Compliance
Treatment outcome
Intensive care, surgical

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013