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Not yet recruiting NCT04763161

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

Observational Ischemic Cerebrovascular Accident

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Decompressive hemicraniectomy, neurosurgical operation.
Who it may be relevant to
Registry conditions: Ischemic Cerebrovascular Accident. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • neutrophil polynuclear cells levels [Time frame: Day 0]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT04763161 · BMR_2021_2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗