StrokeREAVCNCT04434287
Study of Prognostic Factors in Patients Admitted to ICU for Stroke
An observational study of Stroke and Critically Ill, run by University Hospital, Brest at 1 site in France.
Trial summary
Outcome of stroke patients admitted to the intensive care unit the intensive care unit (ICU) is poor and haemorrhagic stroke, fixed dilated pupil(s) and GCS <10 are associated with increased mortality and poor functional outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Critically Ill
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2020to 29 Jun 2020
- How long will I take part?
- 1 Month
- 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: All patients with acute stroke admitted to ICU in the Brest Teaching Hospital (Cavale Blanche) BREST (The Brest REgistry of STroke)
Who may be able to join
- acute stroke
- ICU admission for acute stroke
- 1 organ dysfunction : coma, shock, respiratory failure
Who cannot join
- refuse participation
Trial locations and contacts
1 site in 1 country.
About this study
Outcome of stroke patients admitted to the intensive care unit the intensive care unit (ICU) is poor and haemorrhagic stroke, fixed dilated pupil(s) and GCS <10 are associated with increased mortality and poor functional outcome. However little is known about the impact of clinical events occuring during the ICU stay (ventilator acquired pneumoniae, shock, dysglycemia....).
The objective of this study was to determine the mortality rate and the functional outcomes of stroke patients admitted to ICU and to identify predictors of poor outcome in this population.
- Conditions
- Stroke, Critically Ill
- Medical subject headings
- Stroke, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: through ICU hospitalization, an average of one month
Secondary outcomes (2)
Mortality
Mortality
Measured: At 90 days
Functional outcome: Modified Rankin Score
Modified Rankin Score (0: no symptoms at all; 6: dead)
Measured: at hospitalization discharge, an average of three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start12 Jun 2020
- Primary completion29 Jun 2020
- Study completion29 Jun 2020
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 University Hospital, BrestThe 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
- Other
- Enrolment
- 204 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434287
- Sponsor's protocol ID
- REAVC ( 29BRC20.0062)
- Acronym
- REAVC
- Status last verified
- Apr 2020
- First submitted
- 4 Jun 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prognostic Factors in Patients Admitted to ICU for Stroke
- ClinicalTrials.gov ID
- NCT04434287
- Acronym / sponsor ID
- REAVC / REAVC ( 29BRC20.0062)
- Conditions
- Stroke, Critically Ill
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 29 Jun 2020 (actual)
- First posted
- 16 Jun 2020 (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.
Outcome of stroke patients admitted to the intensive care unit the intensive care unit (ICU) is poor and haemorrhagic stroke, fixed dilated pupil(s) and GCS <10 are associated with increased mortality and poor functional outcome. However little is known about the impact of clinical events occuring during the ICU stay (ventilator acquired pneumoniae, shock, dysglycemia....).
The objective of this study was to determine the mortality rate and the functional outcomes of stroke patients admitted to ICU and to identify predictors of poor outcome in this population.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with acute stroke admitted to ICU in the Brest Teaching Hospital (Cavale Blanche) BREST (The Brest REgistry of STroke)
Key inclusion criteria (3 listed)
- acute stroke
- ICU admission for acute stroke
- 1 organ dysfunction : coma, shock, respiratory failure
Key exclusion criteria (1 listed)
- refuse participation
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
Mortality
Time frame: through ICU hospitalization, an average of one month
2 secondary outcomes
Mortality
Time frame: At 90 days
Functional outcome: Modified Rankin Score
Time frame: at hospitalization discharge, an average of three months
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 Aug 2020.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Stroke
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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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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
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 and Critically Ill, run by University Hospital, Brest 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 3 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 Aug 2020. 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?
Mortality (time frame: through ICU hospitalization, an average of one month). 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 Aug 2020.