ICP Versus Intracranial Compliance Guided Management in SAH - Full Text View

Sponsored by:	Rikshospitalet HF
Information provided by:	Rikshospitalet HF
ClinicalTrials.gov Identifier:	NCT00248690

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Intracranial Pressure (ICP) Versus Intracranial Compliance (ICC) Guided Management in Subarachnoid Hemorrhage; - a Prospective, Randomized Trial.

Further study details as provided by Rikshospitalet HF:

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
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Rikshospitalet HF

Investigators

Study Director:

Gunnar Bentsen, MD

Rikshospitalet HF

More Information

Responsible Party:	Rikshospitalet-Radiumhospitalet HF ( Audun Stubhaug / Professor )
Study ID Numbers:	2005-SAHD, S-05184
Study First Received:	October 25, 2005
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00248690
Health Authority:	Norway: Norwegian Medicines Agency; Norway: The Data Inspectorate; Norway: Directorate for Health and Social Affairs

Keywords provided by Rikshospitalet HF:

Subarachnoid hemorrhage
Intracranial hypertension
Intracranial pressure
Diagnostic techniques and procedures

Compliance
Treatment outcome
Intensive care, surgical

Study placed in the following topic categories:

Pseudotumor cerebri
Vascular Diseases
Pseudotumor Cerebri
Subarachnoid Hemorrhage
Central Nervous System Diseases
Intracranial Hemorrhages

Brain Diseases
Hemorrhage
Cerebrovascular Disorders
Intracranial Hypertension
Hypertension

Additional relevant MeSH terms:

Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009