Subarachnoid HemorrhageProReSHANCT02890004
Observational Study of Patients With Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This prospective, observational study aim to identify : Prognostic factor of patients with subarachnoid haemorrhage in neuro intensive care unit The impact of standard therapeutic used (surgery, embolization ; medical treatment of vasospasm ; treatment of complications like hyponatremia, stress myocardiopathy, …) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2017to 16 Mar 2020
- 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 admitted to the unit of investigator with subarachnoid hemorrhage, whatever the etiology, is included in their prospective registry
Who may be able to join
- Subarachnoid hemorrhage
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de réanimation polyvalente neurologique Hôpital Neurologique HCL
Bron, 69500
Frédéric DAILLER, MD, 472 35 75 76 ext. +33, frederic.dailler@chu-lyon.fr
Frédéric DAILLER, MD
About this study
Official title: A Prospective, Observational Registry of Patient With Subarachnoid Hemorrhage in Neurocritical Care Unit
This prospective, observational study aim to identify :
- Prognostic factor of patients with subarachnoid haemorrhage in neuro intensive care unit
- The impact of standard therapeutic used (surgery, embolization ; medical treatment of vasospasm ; treatment of complications like hyponatremia, stress myocardiopathy, …)
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Subarachnoid Hemorrhage, Neurointensive care, Observational registry
- Medical subject headings
- Subarachnoid Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: at day 0
Survival
Measured: at 6 months
Survival
Measured: at 12 months
Secondary outcomes (10)
Neurological outcome with the Glasgow Coma Scale (GCS) score
Measured: at day 0
Neurological outcome with the Glasgow Coma Scale (GCS) score
Measured: at 6 months
Neurological outcome with the Glasgow Coma Scale (GCS) score
Measured: at 12 months
Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score
Measured: at day 0
Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score
Measured: at 6 months
Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score
Measured: at 12 months
Brain lesions with MRI
Measured: at day 0
Brain lesions with MRI
Measured: at 6 months
Brain lesions with MRI
Measured: at 12 months
delay of apparition of hyponatremia
Natremia in standard blood sample, Natremia is routinelly evaluated on alternte days, and more if required.
Measured: on alternte days after Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start16 Feb 2017
- Primary completion16 Mar 2020 (estimated)
- Study completion16 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric DAILLER, MD, Principal investigator, Service de réanimation neurologique Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890004
- Sponsor's protocol ID
- 69HCL16_0561
- Acronym
- ProReSHA
- Status last verified
- Feb 2018
- First submitted
- 24 Aug 2016
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chardon N, Nourredine M, Ledochowski S, Kurland NT, Dailler F, Ritzenthaler T, Nougier C, Balanca B. Trajectory of mean platelet volume changes after aneurysmal subarachnoid hemorrhage in patients with or without delayed cerebral ischemia. Sci Rep. 2024 Oct 24;14(1):25122. doi: 10.1038/s41598-024-75587-8.
PubMed 39448701
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Registry of Patient With Subarachnoid Hemorrhage in Neurocritical Care Unit
- ClinicalTrials.gov ID
- NCT02890004
- Acronym / sponsor ID
- ProReSHA / 69HCL16_0561
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Subarachnoid Hemorrhage, Neurointensive care, Observational registry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 16 Mar 2020 (estimated)
- Study completion
- 16 Mar 2020 (estimated)
- First posted
- 7 Sep 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.
This prospective, observational study aim to identify :
- Prognostic factor of patients with subarachnoid haemorrhage in neuro intensive care unit
- The impact of standard therapeutic used (surgery, embolization ; medical treatment of vasospasm ; treatment of complications like hyponatremia, stress myocardiopathy, …)
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
- All patients admitted to the unit of investigator with subarachnoid hemorrhage, whatever the etiology, is included in their prospective registry
Key inclusion criteria (1 listed)
- Subarachnoid hemorrhage
Key exclusion criteria (1 listed)
- None
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
Survival
Time frame: at day 0
Survival
Time frame: at 6 months
Survival
Time frame: at 12 months
10 secondary outcomes
Neurological outcome with the Glasgow Coma Scale (GCS) score
Time frame: at day 0
Neurological outcome with the Glasgow Coma Scale (GCS) score
Time frame: at 6 months
Neurological outcome with the Glasgow Coma Scale (GCS) score
Time frame: at 12 months
Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score
Time frame: at day 0
Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score
Time frame: at 6 months
Neuropsychological outcome with the Montreal Cognitive Assessment (MoCA) score
Time frame: at 12 months
Brain lesions with MRI
Time frame: at day 0
Brain lesions with MRI
Time frame: at 6 months
Brain lesions with MRI
Time frame: at 12 months
delay of apparition of hyponatremia
Time frame: on alternte days after Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Derived from this study: PubMed 39448701Chardon N, Nourredine M, Ledochowski S, Kurland NT, Dailler F, Ritzenthaler T, Nougier C, Balanca B. Trajectory of mean platelet volume changes after aneurysmal subarachnoid hemorrhage in patients with or without delayed cerebral ischemia. Sci Rep. 2024 Oct 24;14(1):25122. doi: 10.1038/s41598-024-75587-8.
- Individual participant dataSharing planned: No
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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.
Frédéric DAILLER, MD principal investigator
Service de réanimation neurologique Hospices Civils de Lyon
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 Subarachnoid Hemorrhage, run by Hospices Civils de Lyon 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 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: status not confirmed, as of the sponsor's last update on 23 Feb 2018. 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 Frédéric DAILLER, MD (4 72 35 75 76 ext. +33, frederic.dailler@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: at day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02890004, which also lists 1 linked publication.
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 23 Feb 2018.