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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04763161
Other study ID # BMR_2021_2
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 15, 2024
Est. completion date March 15, 2026

Study information

Verified date April 2024
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact Benjamin Dr Maier
Phone 0148036454
Email bmaier@for.paris
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date March 15, 2026
Est. primary completion date October 15, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Outcome

Type Measure Description Time frame Safety issue
Primary neutrophil polynuclear cells levels Day 0
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