Cerebral StrokeNCT02827825
Patients Undergoing Strokes Admitted in Intensive Care Requiring Neurosurgical ICU Crossing: Patient Profile and Prognosis
An observational study of Cerebral Stroke, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The aim of this study is to describe the population of patients admitted to the ICU in neurosurgery for stroke requiring secondary care in intensive care and their future. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Stroke
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Jan 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: Patients admitted in Intensive Care Requiring Neurosurgical for ischemic or hemorrhagic stroke. then, admitted secondarily in ICU
Who may be able to join
- Admitted USINV for ischemic or hemorrhagic stroke
- Admitted secondarily in ICU
Who cannot join
- Admission in ICU in first
- Administrative Admission in Intensive Care Requiring Neurosurgical within the thrombolysis alert regulated by the neurovascular guard but going directly to ICU imaging waning
- Subarachnoid hemorrhage
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
The aim of this study is to describe the population of patients admitted to the ICU in neurosurgery for stroke requiring secondary care in intensive care and their future.
Read the detailed description
Methodology :
DESIGN:
Retrospective observational study single center, non-interventional Term study over 2 years, retrospectively
Acquisition of data:
- Study of computer file: report available on DxCare hospital and Cora
- Collection of data as excel spreadsheet
- Statistical analysis: local management
- Anonymity of data:
- For each subject will be awarded an identifier (original name and surname - year of birth) and the data will be entered on a computer file which will be sent to the statistician in charge of analyzing the GHPSJ site. There will be no exchange of personal data for this study is single center on the site GHPSJ.
Development of the study:
- Procedure:
- Series includable patients from the PMSI data
- Select folders according the inclusion criteria
- Collecting information from files on Excel spreadsheet by the internal charge of data collection (Sylvain CHAWKI)
- Statistical Analysis
- Writing Article
- Expected duration of patient recruitment: Retrospective of 2 and a half years from January 1, 2013 to April 31, 2015
- Conditions
- Cerebral Stroke
- Being tested
- No intervention
- Keywords
- Neurosurgical, Intensive Care
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention. It's a study on retrospective Data
What is being measured
The primary outcome is the main question the study is designed to answer.
Death event
Measured: Day 1 after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startSep 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral StrokeStudies of the same condition, open and under way.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ZUBER Mathieru, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827825
- Sponsor's protocol ID
- AVC REANIMATION
- Status last verified
- Jun 2016
- First submitted
- 30 Jun 2016
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients Undergoing Strokes Admitted in Intensive Care Requiring Neurosurgical ICU Crossing: Patient Profile and Prognosis
- ClinicalTrials.gov ID
- NCT02827825
- Acronym / sponsor ID
- AVC REANIMATION
- Conditions
- Cerebral Stroke
- Keywords
- Neurosurgical, Intensive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 11 Jul 2016 (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.
The aim of this study is to describe the population of patients admitted to the ICU in neurosurgery for stroke requiring secondary care in intensive care and their future.
Detailed description
Methodology :
DESIGN:
Retrospective observational study single center, non-interventional Term study over 2 years, retrospectively
Acquisition of data:
- Study of computer file: report available on DxCare hospital and Cora
- Collection of data as excel spreadsheet
- Statistical analysis: local management
- Anonymity of data:
- For each subject will be awarded an identifier (original name and surname - year of birth) and the data will be entered on a computer file which will be sent to the statistician in charge of analyzing the GHPSJ site. There will be no exchange of personal data for this study is single center on the site GHPSJ.
Development of the study:
- Procedure:
- Series includable patients from the PMSI data
- Select folders according the inclusion criteria
- Collecting information from files on Excel spreadsheet by the internal charge of data collection (Sylvain CHAWKI)
- Statistical Analysis
- Writing Article
- Expected duration of patient recruitment: Retrospective of 2 and a half years from January 1, 2013 to April 31, 2015
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
- Patients admitted in Intensive Care Requiring Neurosurgical for ischemic or hemorrhagic stroke. then, admitted secondarily in ICU
Key inclusion criteria (2 listed)
- Admitted USINV for ischemic or hemorrhagic stroke
- Admitted secondarily in ICU
Key exclusion criteria (3 listed)
- Admission in ICU in first
- Administrative Admission in Intensive Care Requiring Neurosurgical within the thrombolysis alert regulated by the neurovascular guard but going directly to ICU imaging waning
- Subarachnoid hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention. It's a study on retrospective Data | Other | – |
Primary outcome
Death event
Time frame: Day 1 after hospitalization
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 27 Apr 2023.
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
ZUBER Mathieru, MD principal investigator
Fondation Hôpital Saint-Joseph
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 Cerebral Stroke, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 2 inclusion and 3 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 27 Apr 2023. 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 France. 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 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?
Death event (time frame: Day 1 after hospitalization). 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 2023.