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

NCT ID: NCT04763161

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-08-15
• Study Completion Date: 2027-03-15

Brief 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.

Conditions

Ischemic Cerebrovascular Accident

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Decompressive hemicraniectomy

Intervention Type: PROCEDURE

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

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.

neurosurgical operation

Intervention Type: PROCEDURE

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

Interventions

Decompressive hemicraniectomy

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

Intervention Type: PROCEDURE

neurosurgical 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Benjamin MAIER, Professor, MD, PhD

Role: CONTACT

bmaier@for.paris

01 48 03 72 13 ext. + 33

Amélie Dr YAVCHITZ, MD

Role: CONTACT

ayavchitz@for.paris

01 48 03 64 54 ext. + 33

Other Identifiers

BMR_2021_2

Identifier Type: -

Identifier Source: org_study_id