Clinical trial NCT05621850: Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response
Official title: Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Arterio-venous Malformation
Keywords: Arterio-venous malformation
DMSO
Immune response
Cytokines
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in blood concentrations of cytokines of the innate immune response
timeFrame: Hour 0 and Hour 6
Secondary outcomes:
measure: blood concentrations of cytokines of adaptive and innate immune response
timeFrame: Hour 0 and Hour 24
measure: blood concentrations of cytokines
timeFrame: Hour 6
measure: blood concentrations of cytokines of adaptive immune response
timeFrame: Hour 0 and Hour 6
measure: blood concentrations of cytokines according to the volume of embolizing agent
timeFrame: Hour 0 and Hour 6
measure: blood concentrations of cytokines according to the embolizing agent
timeFrame: Hour 0 and Hour 6
measure: Cortisol production
timeFrame: Hour 0 and Hour 6
measure: lymphocyte subpopulations differences
timeFrame: Hour 24 and Hour 0
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges University Hospital
Study officials:
References: