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Clinical Trials/NCT00248690
NCT00248690
Completed
Not Applicable

Intracranial Pressure (ICP) Versus Intracranial Compliance (ICC) Guided Management in Subarachnoid Hemorrhage; - a Prospective, Randomized Trial.

Oslo University Hospital1 site in 1 country100 target enrollmentNovember 2005
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ConditionsSubarachnoid Hemorrhage (SAH)

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Subarachnoid Hemorrhage (SAH)
Sponsor
Oslo University Hospital
Enrollment
100
Locations
1
Primary Endpoint
All cause mortality and neurological outcome
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 2005
End Date
June 2009
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

  • •Subarachnoid hemorrhage, acute
  • •Intracerebral pressure monitoring device inserted
  • •Exclusion criteria:
  • •No intracranial pressure monitoring
  • •Age \< 18 years

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

All cause mortality and neurological outcome

Time Frame: 3 and 12 months

Secondary Outcomes

  • Length of stay (ICU, hospital); complications; effect of treatment modalities on mean ICP, CPP, ICP mean wave amplitude.(Hospital stay)

Study Sites (1)

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