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

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ClinicalTrials.gov Identifier: NCT04763161
Recruitment Status : Not yet recruiting
First Posted : February 21, 2021
Last Update Posted : December 27, 2021
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Study Description
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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.

Condition or disease Intervention/treatment
Ischemic Cerebrovascular Accident Procedure: Decompressive hemicraniectomy Procedure: neurosurgical operation

Study Design
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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Immuno-inflammation in the Acute Phase of an Ischaemic Cerebral Accident Managed by Decompressive Hemicraniectomy: a Case-control Study
Estimated Study Start Date : February 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : May 2025
Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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.

 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.


Outcome Measures
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Primary Outcome Measures :
  1. neutrophil polynuclear cells levels [ Time Frame: Day 0 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04763161


Contacts
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Contact: Benjamin Dr Maier 0148036454 bmaier@for.paris
Contact: Amélie Dr Yavchitz 0148036454 ayavchitz@for.paris

Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
More Information
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT04763161    
Other Study ID Numbers: BMR_2021_2
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: December 27, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Inflammation
Ischemia
Pathologic Processes
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases