ICP Versus Intracranial Compliance Guided Management in SAH

• Sponsor: Oslo University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00248690
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 43
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Subarachnoid Hemorrhage (SAH)	Device: ICP mean wave amplitude	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Official Title: Intracranial Pressure (ICP) Versus Intracranial Compliance (ICC) Guided Management in Subarachnoid Hemorrhage; - a Prospective, Randomized Trial.
• Study Start Date: Nov 1, 2005
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Outcome Measures

Primary Outcome Measures

1. All cause mortality and neurological outcome [3 and 12 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subarachnoid hemorrhage, acute

• Intracerebral pressure monitoring device inserted

Exclusion criteria:

• No intracranial pressure monitoring

• Age < 18 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rikshospitalet University Hospital	Oslo		Norway	0027

Sponsors and Collaborators

• Oslo University Hospital

Investigators

• Study Director: Gunnar Bentsen, MD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00248690
• Other Study ID Numbers: 2005-SAHD; S-05184
• First Posted: Nov 4, 2005
• Last Update Posted: Jan 19, 2011
• Last Verified: Jan 1, 2008

• Keywords provided by , ,: Subarachnoid hemorrhage; Intracranial hypertension; Intracranial pressure; Diagnostic techniques and procedures; Compliance; Treatment outcome; Intensive care, surgical
• Additional relevant MeSH terms: Subarachnoid Hemorrhage; Hemorrhage

Study Results

No Results Posted as of Jan 19, 2011