Ischemic Cerebrovascular AccidentNEUTROSURGERYNCT04763161
Immuno-inflammation in the Acute Phase of an Ischaemic Cerebral Accident Managed by Decompressive Hemicraniectomy: a Case-control Study
An observational study of Ischemic Cerebrovascular Accident, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
The objective of the NEUTROSURGERY study is to describe the local and locoregional immuno-inflammatory activity in patients suffering from malignant sylvian ischaemic cerebral accident and treated with decompressive hemicraniectomy compared to a control population of patients to be operated on in neurosurgery for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Cerebrovascular Accident
- What is being tested?
- Decompressive hemicraniectomy and neurosurgical operation
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 15 Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population concerns patients suffering from malignant sylvian ischaemic cerebral accident and treated with decompressive hemicraniectomy. Eligibility will be assessed as soon as the first results of the MRI or brain scan carried out as part of the thrombolysis alert by the interventional neurologist or neuroradiologist triggering the treatment, in front of a large ischaemic cerebral accident (>145 ml).
Who may be able to join
- Collegial indication given by a neurologist, a neuroreanimator and a neurosurgeon for HD in the context of a malignant sylvian AIC.
- For neurosurgical operations in which cranial, meningeal, vascular (branch of the middle meningeal artery) or cerebral bone tissue is not preserved during the surgical approach.
- Non-inclusion Criteria Patients:
- HD carried out in a context of acute cerebral haemorrhage
- Pre-existing neurological disability: modified Rankin score > 2
- Patient benefiting from a legal protection measure
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- Non-inclusion Criteria Controls:
- Patient to be operated on for an acute vascular condition: meningeal haemorrhage, subdural or extradural haemorrhage, intra parenchymal haemorrhage.
- Patient operated on for an osteomeningeal pathology present at the approach site.
- Patient operated on for an infectious cranial or neuro-meningeal pathology.
- Patient to be operated on as a result of an intracranial traumatic condition
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The objective of the NEUTROSURGERY study is to describe the local and locoregional immuno-inflammatory activity in patients suffering from malignant sylvian ischaemic cerebral accident and treated with decompressive hemicraniectomy compared to a control population of patients to be operated on in neurosurgery for another neurosurgical pathology.
- Conditions
- Ischemic Cerebrovascular Accident
- Being tested
- Decompressive hemicraniectomy, neurosurgical operation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompressive hemicraniectomyProcedure or surgery
Decompressive hemicraniectomy in the context of a malignat sylvian ischaemic cerebral accident
neurosurgical operationProcedure or surgery
neurosurgical operation on which cranial, meningeal, vascular (branch of the middle meningeal artery) or cerebral bone tissue is not preserved during the surgical approach.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Patients suffering from malignant sylvian ischaemic cerebral accident and treated with decompressive hemicraniectomy.
Intervention is decompressive hemicraniectomy in the context of a malignant sylvian ischaemic cerebral Receives: Procedure: Decompressive hemicraniectomy | |
| Control group | Patients not suffering from AIC, hospitalised in neurosurgery for another reason,
Patients to be opered on which cranial, meningeal, vascular (branch of the middle meningeal artery) or cerebral bone tissue is not preserved during the surgical approach. Receives: Procedure: neurosurgical operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
neutrophil polynuclear cells levels
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start15 Aug 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763161
- Sponsor's protocol ID
- BMR_2021_2
- Acronym
- NEUTROSURGERY
- Status last verified
- Jan 2026
- First submitted
- 11 Feb 2021
- Last updated
- 20 Jan 2026
- 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immuno-inflammation in the Acute Phase of an Ischaemic Cerebral Accident Managed by Decompressive Hemicraniectomy: a Case-control Study
- ClinicalTrials.gov ID
- NCT04763161
- Acronym / sponsor ID
- NEUTROSURGERY / BMR_2021_2
- Conditions
- Ischemic Cerebrovascular Accident
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 21 Feb 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.
The objective of the NEUTROSURGERY study is to describe the local and locoregional immuno-inflammatory activity in patients suffering from malignant sylvian ischaemic cerebral accident and treated with decompressive hemicraniectomy compared to a control population of patients to be operated on in neurosurgery for another neurosurgical pathology.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Procedure: Decompressive hemicraniectomyPatients suffering from malignant sylvian ischaemic cerebral accident and treated with decompressive hemicraniectomy. Intervention is decompressive hemicraniectomy in the context of a malignant sylvian ischaemic cerebral |
| Control group | – | Procedure: neurosurgical operationPatients not suffering from AIC, hospitalised in neurosurgery for another reason, Patients to be opered on which cranial, meningeal, vascular (branch of the middle meningeal artery) or cerebral bone tissue is not preserved during the surgical approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population concerns patients suffering from malignant sylvian ischaemic cerebral accident and treated with decompressive hemicraniectomy. Eligibility will be assessed as soon as the first results of the MRI or brain scan carried out as part of the thrombolysis alert by the interventional neurologist or neuroradiologist triggering the treatment, in front of a large ischaemic cerebral accident (>145 ml).
Key inclusion criteria (11 listed)
- Collegial indication given by a neurologist, a neuroreanimator and a neurosurgeon for HD in the context of a malignant sylvian AIC.
- For neurosurgical operations in which cranial, meningeal, vascular (branch of the middle meningeal artery) or cerebral bone tissue is not preserved during the surgical approach.
- HD carried out in a context of acute cerebral haemorrhage
- Pre-existing neurological disability: modified Rankin score > 2
- Patient benefiting from a legal protection measure
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Decompressive hemicraniectomyDecompressive hemicraniectomy in the context of a malignat sylvian ischaemic cerebral accident | Procedure or surgery | Experimental group |
| neurosurgical operationneurosurgical operation on which cranial, meningeal, vascular (branch of the middle meningeal artery) or cerebral bone tissue is not preserved during the surgical approach. | Procedure or surgery | Control group |
Primary outcome
neutrophil polynuclear cells levels
Time frame: Day 0
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 20 Jan 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Cerebrovascular Accident, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 11 inclusion and 0 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: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Benjamin MAIER, Professor, MD, PhD (01 48 03 72 13 ext. + 33, bmaier@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neutrophil polynuclear cells levels (time frame: Day 0). 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 20 Jan 2026.