ICP Versus Intracranial Compliance Guided Management in SAH | NCT00248690

Studies
ICP Versus Intracranial Compliance Guided Management in SAH

NCT00248690

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Jan 19, 2011Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Subarachnoid Hemorrhage (SAH)

Interventions

ICP mean wave amplitude

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
S-05184

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Feb 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Oct 25, 2005

First Submission Date that Met QC Criteria

Nov 3, 2005

First Posted Date

Nov 4, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2011

Last Update Posted Date

Jan 19, 2011Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ICP mean wave amplitude	Device	Appropriate measures when ICP mean wave amplitude is to high, e.g. CSF drainage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All cause mortality and neurological outcome		3 and 12 months

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subarachnoid hemorrhage, acute
Intracerebral pressure monitoring device inserted

Exclusion criteria:

No intracranial pressure monitoring
Age < 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gunnar Bentsen, MD	Oslo University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rikshospitalet University Hospital		Oslo		0027	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22324419	Derived	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.

ID	Term
D013345	Subarachnoid Hemorrhage
D019586	Intracranial Hypertension
D010349	Patient Compliance

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases