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

F

Fondation Ophtalmologique Adolphe de Rothschild

Status

Begins enrollment in 6 months

Conditions

Ischemic Cerebrovascular Accident

Treatments

Procedure: Decompressive hemicraniectomy
Procedure: neurosurgical operation

Study type

Observational

Funder types

NETWORK

Identifiers

NCT04763161
BMR_2021_2

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

90 participants in 2 patient groups

Experimental group
Description:
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
Treatment:
Procedure: Decompressive hemicraniectomy
Control group
Description:
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.
Treatment:
Procedure: neurosurgical operation

Trial contacts and locations

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Central trial contact

Amélie Dr YAVCHITZ, MD; Benjamin MAIER, Professor, MD, PhD

Data sourced from clinicaltrials.gov

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