ICP Waveform Analysis in Stroke Patients | NCT00509119

Studies
ICP Waveform Analysis in Stroke Patients

NCT00509119

Sponsor

Oslo University Hospital

Status

Withdrawn

Last Update Posted

Apr 27, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Stroke

Interventions

Not provided

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

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Change of workplace for leading investigator, not replaced

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Not provided

Completion Date

Dec 2008Estimated

First Submitted Date

Jul 30, 2007

First Submission Date that Met QC Criteria

Jul 30, 2007

First Posted Date

Jul 31, 2007Estimated

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

Apr 24, 2015

Last Update Posted Date

Apr 27, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a study on how acute clinical state and final clinical outcome in patients with stroke (exclusive subarachnoid hemorrhage) relate to ICP/ABP-derived pressure waveform parameters recorded during intensive care management.

Detailed Description

Aim of study:

Prospectively collect clinical and radiological data as well as management data.
Perform retrospective analysis of ICP/ABP recordings (mean ICP, mean ICP wave amplitude, mean ABP, mean ABP wave amplitude, CPP)
Relate the prospectively collected data with results of retrospective pressure analysis.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Measure	Description	Time Frame
Clinical outcome		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute apoplexy

Exclusion Criteria:

Subarachnoidal bleeding

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

Acute ICH

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gunnar Bentsen, MD	Oslo University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rikshospitalet - Radiumhospitalet HF		Oslo			Norway

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided