Subarachnoid Hemorrhage, AneurysmalO2-VASONCT03361722
Interest of Tissue Oxygen Pressure (PtiO2) Monitoring to Detect a Vasospasm Post Aneurysmal Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage, Aneurysmal, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
Vasospasm is a current complication after aneurysmal subarachnoid hemorrhage and often and often associated with brain ischemia. This complication is difficult to detect, because clinical examination is hardly helpful in sedated patients and the performances of transcranial doppler can only detect the spasm of middle… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2015to 15 Sep 2016
- 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: Adult patients, hospitalized in intensive care unit and sedated, with severe aneurysmal subarachnoid hemorrhage
Who may be able to join
- severe aneurysmal subarachnoid hemorrhage
- patient sedated
- patient hospitalized in intensive care unit between January 2013 and August 2015
- multimodal neurologic monitoring including Tissue Oxygen Pressure and transcranial doppler
Who cannot join
- insonation impossible
About this study
Vasospasm is a current complication after aneurysmal subarachnoid hemorrhage and often and often associated with brain ischemia. This complication is difficult to detect, because clinical examination is hardly helpful in sedated patients and the performances of transcranial doppler can only detect the spasm of middle cerebral arteries.
Tissue Oxygen Pressure (PtiO2) Monitoring allows early detection of brain oxygenation local modifications and of brain ischemia, via continuous monitoring.
This study aims to assess the performance of the tissue oxygen pressure monitoring in detecting a vasospasm post aneurysmal subarachnoid hemorrhage.
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Medical subject headings
- Subarachnoid Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Oxygen Pressure
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start15 Feb 2015
- Primary completion15 Sep 2016
- Study completion15 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361722
- Sponsor's protocol ID
- CE_20151215_1_SWG
- Acronym
- O2-VASO
- Status last verified
- Nov 2017
- First submitted
- 29 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Tissue Oxygen Pressure (PtiO2) Monitoring to Detect a Vasospasm Post Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT03361722
- Acronym / sponsor ID
- O2-VASO / CE_20151215_1_SWG
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 15 Feb 2015 (actual)
- Primary completion
- 15 Sep 2016 (actual)
- Study completion
- 15 Sep 2016 (actual)
- First posted
- 5 Dec 2017 (actual)
- 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.
Vasospasm is a current complication after aneurysmal subarachnoid hemorrhage and often and often associated with brain ischemia. This complication is difficult to detect, because clinical examination is hardly helpful in sedated patients and the performances of transcranial doppler can only detect the spasm of middle cerebral arteries.
Tissue Oxygen Pressure (PtiO2) Monitoring allows early detection of brain oxygenation local modifications and of brain ischemia, via continuous monitoring.
This study aims to assess the performance of the tissue oxygen pressure monitoring in detecting a vasospasm post aneurysmal subarachnoid hemorrhage.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients, hospitalized in intensive care unit and sedated, with severe aneurysmal subarachnoid hemorrhage
Key inclusion criteria (4 listed)
- severe aneurysmal subarachnoid hemorrhage
- patient sedated
- patient hospitalized in intensive care unit between January 2013 and August 2015
- multimodal neurologic monitoring including Tissue Oxygen Pressure and transcranial doppler
Key exclusion criteria (1 listed)
- insonation impossible
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
Tissue Oxygen Pressure
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, Aneurysmal, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 4 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: finished, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tissue Oxygen Pressure (time frame: baseline). 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 5 Dec 2017.