COVID-19 PandemicNeurochirCOVIDNCT04701905
The Offer of Neurosurgery Care in the Grand Est of France During the Health Crisis Linked to Covid-19
An observational study of COVID-19 Pandemic, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
During this exceptional health crisis, this study of the current care of a neurosurgical activity, which is essential in a University Hospital Centre, will enable us to better understand how we function, the response given to a population with the means at our disposal, the implementation of new therapeutic strategies… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pandemic
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2020to 30 Apr 2021
- 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: Patient entering the neurosurgery care sector requiring treatment between 03/16/2020 and 06/15/2020
Who may be able to join
- Patient aged over 18;
- Entering the neurosurgery care sector requiring support between 03/16/2020 and 06/15/2020;
- Having not expressed his opposition, after information, to the reuse of his data for the purposes of this research.
Who cannot join
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Department of Neurosurgery - Strasbourg University Hospitals
Strasbourg, 67091
François PROUST, MD, PhD, 33 3 88 12 76 12, francois.proust@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, 33 3 88 11 66 90, said.chayer@chru-strasbourg.fr
About this study
During this exceptional health crisis, this study of the current care of a neurosurgical activity, which is essential in a University Hospital Centre, will enable us to better understand how we function, the response given to a population with the means at our disposal, the implementation of new therapeutic strategies and their limits, ethical reflection, and, how to pursue a distributive and quality medicine.
The restriction of conventional medical resources to our care activity (resuscitation, personnel, operating theatre, constraints linked to the risk of contamination...) is leading to a new medical organisation imposing new Covid-19 standards, the description of which seems essential to us.
A knowledge of the strategies to be adopted during a disaster health situation in order to continue providing care to the civilian population. How can we prevent the setting up of health care systems outside the cause of the health crisis? n triage medicine, Avoiding the "burn-out" of doctors struck by the health crisis.
- Conditions
- COVID-19 Pandemic
- Keywords
- COVID-19 Pandemic, Coronavirus, Sars-cov-2
- Medical subject headings
- COVID-19, Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective analysis of the management of neurosurgical pathologies in a health crisis situation of the Covid-19 pandemic
Measured: The files analysed retrospectily from March 16, 2020 to June 15, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start30 Apr 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François PROUST, MD, PhD, Principal investigator, Department of Neurosurgery - Strasbourg University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701905
- Sponsor's protocol ID
- 7780
- Acronym
- NeurochirCOVID
- Status last verified
- Jan 2021
- First submitted
- 7 Jan 2021
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Offer of Neurosurgery Care in the Grand Est of France During the Health Crisis Linked to Covid-19
- ClinicalTrials.gov ID
- NCT04701905
- Acronym / sponsor ID
- NeurochirCOVID / 7780
- Conditions
- COVID-19 Pandemic
- Keywords
- COVID-19 Pandemic, Coronavirus, Sars-cov-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 8 Jan 2021 (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.
During this exceptional health crisis, this study of the current care of a neurosurgical activity, which is essential in a University Hospital Centre, will enable us to better understand how we function, the response given to a population with the means at our disposal, the implementation of new therapeutic strategies and their limits, ethical reflection, and, how to pursue a distributive and quality medicine.
The restriction of conventional medical resources to our care activity (resuscitation, personnel, operating theatre, constraints linked to the risk of contamination...) is leading to a new medical organisation imposing new Covid-19 standards, the description of which seems essential to us.
A knowledge of the strategies to be adopted during a disaster health situation in order to continue providing care to the civilian population. How can we prevent the setting up of health care systems outside the cause of the health crisis? n triage medicine, Avoiding the "burn-out" of doctors struck by the health crisis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient entering the neurosurgery care sector requiring treatment between 03/16/2020 and 06/15/2020
Key inclusion criteria (3 listed)
- Patient aged over 18;
- Entering the neurosurgery care sector requiring support between 03/16/2020 and 06/15/2020;
- Having not expressed his opposition, after information, to the reuse of his data for the purposes of this research.
Key exclusion criteria (3 listed)
- Subject having expressed opposition to participating in the study
- Subject under guardianship or guardianship
- Subject under safeguard of justice
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
Retrospective analysis of the management of neurosurgical pathologies in a health crisis situation of the Covid-19 pandemic
Time frame: The files analysed retrospectily from March 16, 2020 to June 15, 2020 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
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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.
François PROUST, MD, PhD principal investigator
Department of Neurosurgery - Strasbourg University Hospitals
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 COVID-19 Pandemic, run by University Hospital, Strasbourg, France 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 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: status not confirmed, as of the sponsor's last update on 8 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François PROUST, MD, PhD (33 3 88 12 76 12, francois.proust@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective analysis of the management of neurosurgical pathologies in a health crisis situation of the Covid-19 pandemic (time frame: The files analysed retrospectily from March 16, 2020 to June 15, 2020 will be examined]). 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 8 Jan 2021.