Subarachnoidal HemorrhageMultiCUNCT06900101
Multimodal Monitoring Study in Neuro Critical Care
An observational study of Subarachnoidal Hemorrhage and Intacranial Hypertension, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
During the first week after an acute cerebral injury, neurologic clinical exam is often irrelevant, limited by sedation use or spontaneous consciousness disorders. Hence, neurological monitoring of brain oxygen consumption, metabolic disorders, electrical activity is used to follow and prevent delayed cerebral… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Subarachnoidal Hemorrhage, Intacranial Hypertension, Acute Trauma Brain Injury
- What is being tested?
- Study the evolution and correlation between cerebral autoregulation index
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in neuro critical care, in Pierre Wertheimer hospital, for acute brain injury and monitored by MOBERG® system.
Who may be able to join
- - Patients hospitalized in neurologic critical care in Wertheimer Hospital, Bron
- Monitored with the CNS MOBERG® monitoring system
Who cannot join
- - Refusal to participate
- Patients under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Pierre Wertheimer
France, Bron, 69500
Baptiste Balança, 04 72 35 75 76, baptiste.balanca@chu-lyon.fr
About this study
During the first week after an acute cerebral injury, neurologic clinical exam is often irrelevant, limited by sedation use or spontaneous consciousness disorders.
Hence, neurological monitoring of brain oxygen consumption, metabolic disorders, electrical activity is used to follow and prevent delayed cerebral injuries. Among those instruments, numerous are often described: intra cranial pressure monitoring, brain tissue oxygen pressure monitoring, scalp electroencephalography, continuous electroencephalography and Near infrared Red Spectroscopy (NIRS).
Even if the value of some of those technologies are well known, many remain part of a research domain. Here we will not only try to study the correlation between different cerebral autoregulation's index described in the scientific literature but also will we try to identify and describe EEG and cardiorespiratory changes during the first week following brain injury. The objective of this study is to investigate the pathophysiology of acute brain injury and explore potent biomarkers of multimodal monitoring during the first week following acute brain injury.
- Being tested
- Study the evolution and correlation between cerebral autoregulation index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study the evolution and correlation between cerebral autoregulation indexOther
Objective n°1: Study the correlation between autoregulation index:
The investigators will look for a correlation between several auroregulation index such as the PRx, ORx and Cox.
Objective n°2: Evaluation and detection of EEG prognostic patterns: The investigators will look for quantitaive EEG changes during the early phase of acute brain injuries.
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted in neurocritical care in Pierre Wertheimer hospital, following acute brain injury, | Not described Receives: Other: Study the evolution and correlation between cerebral autoregulation index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between ORx and PRx
Measured: Multimodal neuro monitoring is used from 1 to 15 days after the acute brain injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Jan 2020
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoidal 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900101
- Sponsor's protocol ID
- 713
- Acronym
- MultiCU
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Monitoring Study in Neuro Critical Care
- ClinicalTrials.gov ID
- NCT06900101
- Acronym / sponsor ID
- MultiCU / 713
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 28 Mar 2025 (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 the first week after an acute cerebral injury, neurologic clinical exam is often irrelevant, limited by sedation use or spontaneous consciousness disorders.
Hence, neurological monitoring of brain oxygen consumption, metabolic disorders, electrical activity is used to follow and prevent delayed cerebral injuries. Among those instruments, numerous are often described: intra cranial pressure monitoring, brain tissue oxygen pressure monitoring, scalp electroencephalography, continuous electroencephalography and Near infrared Red Spectroscopy (NIRS).
Even if the value of some of those technologies are well known, many remain part of a research domain. Here we will not only try to study the correlation between different cerebral autoregulation's index described in the scientific literature but also will we try to identify and describe EEG and cardiorespiratory changes during the first week following brain injury. The objective of this study is to investigate the pathophysiology of acute brain injury and explore potent biomarkers of multimodal monitoring during the first week following acute brain injury.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted in neurocritical care in Pierre Wertheimer hospital, following acute brain injury, | – | Other: Study the evolution and correlation between cerebral autoregulation index |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in neuro critical care, in Pierre Wertheimer hospital, for acute brain injury and monitored by MOBERG® system.
Key inclusion criteria (2 listed)
- - Patients hospitalized in neurologic critical care in Wertheimer Hospital, Bron
- Monitored with the CNS MOBERG® monitoring system
Key exclusion criteria (2 listed)
- - Refusal to participate
- Patients under legal protection
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 |
|---|---|---|
| Study the evolution and correlation between cerebral autoregulation indexObjective n°1: Study the correlation between autoregulation index: The investigators will look for a correlation between several auroregulation index such as the PRx, ORx and Cox. Objective n°2: Evaluation and detection of EEG prognostic patterns: The investigators will look for quantitaive EEG changes during the early phase of acute brain injuries. | Other | Patients admitted in neurocritical care in Pierre Wertheimer hospital, following acute brain injury, |
Primary outcome
Correlation between ORx and PRx
Time frame: Multimodal neuro monitoring is used from 1 to 15 days after the acute brain injury.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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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.
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 Subarachnoidal Hemorrhage and Intacranial Hypertension, 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 28 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Baptiste Balança (04 72 35 75 76, baptiste.balanca@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between ORx and PRx (time frame: Multimodal neuro monitoring is used from 1 to 15 days after the acute brain injury.). 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 28 Mar 2025.