Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-05

Study Completion Date

2025-12-05

Brief Summary

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In our ICU, it could notice that patients with cerebral arterio-venous malformation (AVM) treated with embolization develop more severe Ventilator Associated Pneumoniae (VAP) compare to other patients hospitalized for neurological diseases. The Dimethylsulfoxyde (DMSO), the solvent of the embolization implant, is known to have immune effect on vitro analysis. The investigator want to prove that exposition to embolization implant for a cerebral AMV modify the cytokines production involved the system immune's regulation.

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Detailed Description

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Cerebral AVM are defined by abnormal connections between arteries and veins. For treatment of this vascular malformation, embolization is the gold standard. Embolization agent is made with vinylic alcohol ethylene (EVOH) copolymer which (the embolization implant) and the DMSO which is the solvent. During the injection of the product, DMSO dissipates in the bloodstream, and the EVOH precipitates and forms the embolus. It knows that DMSO had in-vitro immune effect (inhibits signalizations ways of innate and acquired immune response, decrease of pro-inflammatory cytokines production and decrease INF-γ and TNF-α production). DMSO could decrease activation and recruitment of leukocytes, which could expose patients to an increased risk of infection.

The investigator will dose cytokines in 3 blood samples (preoperative, H+6 and H+24) in planned patient's hospitalized for cerebral AVM embolization. The cytokine content of the plasmas will be analyzed with multiplex ELISA technic

Conditions

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Cerebral Arterio-venous Malformation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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cerebral AVM embolization

Group Type EXPERIMENTAL

Blood sample

Intervention Type OTHER

Based on supplementary blood sampled before embolization procedure and 6 hours and 24 hours after we will be analyzed cytokines concentration (Elisa test) and cortisol

cerebral aneurism embolization

Group Type OTHER

Blood sample

Intervention Type OTHER

Based on supplementary blood sampled before embolization procedure and 6 hours and 24 hours after we will be analyzed cytokines concentration (Elisa test) and cortisol

Interventions

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Blood sample

Based on supplementary blood sampled before embolization procedure and 6 hours and 24 hours after we will be analyzed cytokines concentration (Elisa test) and cortisol

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult hospitalized for a planned cerebral embolization

Exclusion Criteria

* Immunosuppressed patient or immunosuppressive treatment (corticosteroid included)
* Patient with auto-immune disease
* Hospitalization in ICU or for a planned or emergency surgery in the past three months
* Hospitalization for an active infection in the past three months
* Pregnancy
* Patients requiring steroid therapy to prevent postoperative nausea and/or vomiting

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No