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

NCT04763161 | Not Yet Recruiting

• 1 other identifier: BMR_2021_2
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• neutrophil polynuclear cells levels

  Day 0

Study Arms (2)

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

Decompressive hemicraniectomy PROCEDURE

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

Experimental group

neurosurgical operation 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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Benjamin MAIER, Professor, MD, PhD

CONTACT

01 48 03 72 13; bmaier@for.paris

Amélie Dr YAVCHITZ, MD

CONTACT

01 48 03 64 54; ayavchitz@for.paris

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 21, 2021
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01