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Not yet recruitingNCT04763161NEUTROSURGERYUpdated Jan 20, 2026

Immuno-inflammation in the Acute Phase of an Ischaemic Cerebral Accident Managed by Decompressive Hemicraniectomy: a Case-control Study

An observational study in Ischemic Cerebrovascular Accident, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
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Study 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 another neurosurgical pathology.

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Conditions studied

  • Ischemic Cerebrovascular Accident

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In context

Ischemic Stroke

2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.

This study's planned enrollment of 90 is below the median of 300 across 777 observational studies indexed under Ischemic Stroke.

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Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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).

Eligibility criteria

Inclusion Criteria Patients:

  • Collegial indication given by a neurologist, a neuroreanimator and a neurosurgeon for HD in the context of a malignant sylvian AIC.

Inclusion Criteria Control:

- 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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    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.

    Procedure: neurosurgical operation

Interventions

  • ProcedureDecompressive hemicraniectomy

    Decompressive hemicraniectomy in the context of a malignat sylvian ischaemic cerebral accident

  • Procedureneurosurgical operation

    neurosurgical operation on which cranial, meningeal, vascular (branch of the middle meningeal artery) or cerebral bone tissue is not preserved during the surgical approach.

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What researchers measure

Primary outcomes

  1. neutrophil polynuclear cells levels

    Time frame: Day 0

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04763161
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
Feb 21, 2021
Start date
Aug 15, 2026 (estimated)
Primary completion
Oct 15, 2026 (estimated)
Completion
Mar 15, 2027 (estimated)
Last update
Jan 20, 2026

Study contacts

Benjamin MAIER, Professor, MD, PhD
Contact
bmaier@for.paris
01 48 03 72 13 ext. + 33
Amélie Dr YAVCHITZ, MD
Contact
ayavchitz@for.paris
01 48 03 64 54 ext. + 33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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