ICP Versus Intracranial Compliance Guided Management in SAH

NCT ID: NCT00248690

Last Updated: 2011-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2009-06-30

Brief Summary

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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

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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.

Conditions

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Subarachnoid Hemorrhage (SAH)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Interventions

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ICP mean wave amplitude

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subarachnoid hemorrhage, acute
* Intracerebral pressure monitoring device inserted

Exclusion Criteria

* No intracranial pressure monitoring
* Age \< 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rikshospitalet-Radiumhospitalet HF

Principal Investigators

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Gunnar Bentsen, MD

Role: STUDY_DIRECTOR

Oslo University Hospital

Locations

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Rikshospitalet University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 22324419 (View on PubMed)

Other Identifiers

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S-05184

Identifier Type: -

Identifier Source: secondary_id

2005-SAHD

Identifier Type: -

Identifier Source: org_study_id

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