ICP Versus Intracranial Compliance Guided Management in SAH

Not Applicable

Completed

• Conditions: Subarachnoid Hemorrhage (SAH)

• Registration Number: NCT00248690
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study First Submitted: 2005-10-25
• Study Start: 2005-11
• Study First Submitted QC: 2005-11-03
• Study First Posted: 2005-11-04
• Status Verified: 2008-01
• Primary Completion: 2009-02
• Study Completion: 2009-06
• Last Update Submitted: 2011-01-17
• Last Update Posted: 2011-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Subarachnoid hemorrhage, acute
• Intracerebral pressure monitoring device inserted

Exclusion criteria:

• No intracranial pressure monitoring
• Age < 18 years

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
All cause mortality and neurological outcome	3 and 12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rikshospitalet University Hospital; 🇳🇴 Oslo, Norway