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ICP Versus Intracranial Compliance Guided Management in SAH

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ClinicalTrials.gov Identifier: NCT00248690
Recruitment Status : Completed
First Posted : November 4, 2005
Last Update Posted : January 19, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Subarachnoid Hemorrhage (SAH) Device: ICP mean wave amplitude

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: Intracranial Pressure (ICP) Versus Intracranial Compliance (ICC) Guided Management in Subarachnoid Hemorrhage; - a Prospective, Randomized Trial.
Study Start Date : November 2005
Primary Completion Date : February 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Device: ICP mean wave amplitude
    Appropriate measures when ICP mean wave amplitude is to high, e.g. CSF drainage

Outcome Measures

Primary Outcome Measures :
  1. All cause mortality and neurological outcome [ Time Frame: 3 and 12 months ]

Secondary Outcome Measures :
  1. Length of stay (ICU, hospital); complications; effect of treatment modalities on mean ICP, CPP, ICP mean wave amplitude. [ Time Frame: Hospital stay ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 4, 2005    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: January 2008

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