ICP Versus Intracranial Compliance Guided Management in SAH

Subarachnoid Hemorrhage (SAH) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00248690
• Other study ID #: 2005-SAHD
• Secondary ID: S-05184
• Status: Completed
• Phase: N/A
• First received: October 25, 2005
• Last updated: January 17, 2011
• Start date: November 2005
• Est. completion date: June 2009

Study information

• Verified date: January 2008
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway: The Data InspectorateNorway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subarachnoid hemorrhage, acute

• Intracerebral pressure monitoring device inserted

Exclusion criteria:

• No intracranial pressure monitoring

• Age < 18 years

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage (SAH)

Intervention

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

Locations

Country	Name	City	State
Norway	Rikshospitalet University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality and neurological outcome		3 and 12 months	No
Secondary	Length of stay (ICU, hospital); complications; effect of treatment modalities on mean ICP, CPP, ICP mean wave amplitude.		Hospital stay	Yes