Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response

Study Overview
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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.

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

Official Title
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Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response

Conditions
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Cerebral Arterio-venous Malformation

Intervention / Treatment
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* Other: Blood sample


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cerebral AVM embolization<br> | Other: Blood sample<br>* 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<br>|
| Other: cerebral aneurism embolization<br> | Other: Blood sample<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood concentrations of cytokines of the innate immune response | Compare blood concentrations of cytokines (IL-1N, IL-10, IL-12p70, IL-6, IL-2, IL-4, IL-17A; TNF-a, TGF-b1, IFN-g) of the innate immune response between patients who underwent a cerebral AVM embolization procedure with patients who underwent a cerebral aneurysm embolization procedure between the expected peak at H6 and H0 | Hour 0 and Hour 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood concentrations of cytokines of adaptive and innate immune response | Compare blood concentrations of cytokines (IL-1N, IL-10, IL-12p70, IL-6, IL-2, IL-4, IL-17A; TNF-a, TGF-b1, IFN-g) of adaptive and innate immune response between patients with cerebral AVM embolization procedures and brain aneurysms embolization | Hour 0 and Hour 24 | 
| blood concentrations of cytokines | Compare blood concentrations of cytokines (IL-1N, IL-10, IL-12p70, IL-6, IL-2, IL-4, IL-17A; TNF-a, TGF-b1, IFN-g)according to the duration of the embolization procedure at H6 | Hour 6 | 
| blood concentrations of cytokines of adaptive immune response | Compare blood concentrations of cytokines (IL-1N, IL-10, IL-12p70, IL-6, IL-2, IL-4, IL-17A; TNF-a, TGF-b1, IFN-g)of adaptive immune response between patients with cerebral AVM embolization procedures and brain aneurysms embolization between the expected peak at H6 and H0 | Hour 0 and Hour 6 | 
| blood concentrations of cytokines according to the volume of embolizing agent | Compare blood concentrations of cytokines (IL-1N, IL-10, IL-12p70, IL-6, IL-2, IL-4, IL-17A; TNF-a, TGF-b1, IFN-g)according to the volume of embolizing agent | Hour 0 and Hour 6 | 
| blood concentrations of cytokines according to the embolizing agent | Compare blood concentrations of cytokines (IL-1N, IL-10, IL-12p70, IL-6, IL-2, IL-4, IL-17A; TNF-a, TGF-b1, IFN-g)according to the embolizing agent used during the procedure | Hour 0 and Hour 6 | 
| Cortisol production | Comparison of cortisol levels before and after AMV embolization procedure | Hour 0 and Hour 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arterio-venous malformation, DMSO, Immune response, Cytokines