StrokeNCT00509119
ICP Waveform Analysis in Stroke Patients
An observational study of Stroke, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2006to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute ICH
Who may be able to join
- Acute apoplexy
Who cannot join
- Subarachnoidal bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective ICP Waveform Analysis in Stroke Patients Followed Prospectively
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.
Read the 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.
- Conditions
- Stroke
- Keywords
- apoplexia, Intracranial and intraarterial pressure curves in acute apoplectic patients
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startDec 2006
- Study completionDec 2008 (estimated)
Why it stopped: Change of workplace for leading investigator, not replaced
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Gunnar Bentsen, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509119
- Sponsor's protocol ID
- 1-engum
- Status last verified
- Oct 2010
- First submitted
- 30 Jul 2007
- Last updated
- 27 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective ICP Waveform Analysis in Stroke Patients Followed Prospectively
- ClinicalTrials.gov ID
- NCT00509119
- Acronym / sponsor ID
- 1-engum
- Conditions
- Stroke
- Keywords
- apoplexia, Intracranial and intraarterial pressure curves in acute apoplectic patients
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Change of workplace for leading investigator, not replaced
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Dec 2006
- Study completion
- Dec 2008 (estimated)
- First posted
- 31 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ICH
Key inclusion criteria (1 listed)
- Acute apoplexy
Key exclusion criteria (1 listed)
- Subarachnoidal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical outcome
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Bentsen, MD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2015.