ICP Versus Intracranial Compliance Guided Management in SAH

Oslo University Hospital100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

100

Conditions

Subarachnoid Hemorrhage (SAH)

Interventions

ICP mean wave amplitudeDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rikshospitalet University Hospital

Oslo, Norway

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.

Time frame: Hospital stay

Data from ClinicalTrials.gov

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