NCT00248690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2005

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 19, 2011

Status Verified

January 1, 2008

Enrollment Period

3.3 years

First QC Date

October 25, 2005

Last Update Submit

January 17, 2011

Conditions

Subarachnoid Hemorrhage (SAH)

Keywords

Subarachnoid hemorrhageIntracranial hypertensionIntracranial pressureDiagnostic techniques and proceduresComplianceTreatment outcomeIntensive care, surgical

Outcome Measures

Primary Outcomes (1)

  • All cause mortality and neurological outcome

    3 and 12 months

Secondary Outcomes (1)

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

    Hospital stay

Interventions

ICP mean wave amplitudeDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subarachnoid hemorrhage, acute
  • Intracerebral pressure monitoring device inserted

You may not qualify if:

  • No intracranial pressure monitoring
  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet University Hospital

Oslo, 0027, Norway

Location

Related Publications (1)

  • 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.

    PMID: 22324419DERIVED

MeSH Terms

Conditions

Subarachnoid HemorrhageIntracranial HypertensionPatient Compliance

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Gunnar Bentsen, MD

    Oslo University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2005

First Posted

November 4, 2005

Study Start

November 1, 2005

Primary Completion

February 1, 2009

Study Completion

June 1, 2009

Last Updated

January 19, 2011

Record last verified: 2008-01

Locations

NO(1)