Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 78
- Locations
- 2
- Primary Endpoint
- Change in blood concentrations of cytokines of the innate immune response
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
cerebral AVM embolization
Intervention: Blood sample (Other)
cerebral aneurism embolization
Intervention: Blood sample (Other)
Outcomes
Primary Outcomes
Change in blood concentrations of cytokines of the innate immune response
Time Frame: Hour 0 and Hour 6
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
Secondary Outcomes
- blood concentrations of cytokines according to the volume of embolizing agent(Hour 0 and Hour 6)
- blood concentrations of cytokines of adaptive and innate immune response(Hour 0 and Hour 24)
- blood concentrations of cytokines(Hour 6)
- blood concentrations of cytokines of adaptive immune response(Hour 0 and Hour 6)
- Cortisol production(Hour 0 and Hour 6)
- lymphocyte subpopulations differences(Hour 24 and Hour 0)
- blood concentrations of cytokines according to the embolizing agent(Hour 0 and Hour 6)