PROCESS: Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response

Sponsor

University Hospital, Limoges (Other)

Overall Status

Recruiting

CT.gov ID

NCT05621850

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Arterio-venous Malformation	Other: Blood sample	N/A

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

Anticipated Enrollment :

78 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response

Actual Study Start Date :

Dec 5, 2022

Anticipated Primary Completion Date :

Jun 5, 2024

Anticipated Study Completion Date :

Jun 5, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: cerebral AVM embolization	Other: 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
Other: cerebral aneurism embolization	Other: 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

Arm

Intervention/Treatment

Experimental: cerebral AVM embolization

Other: 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

Other: cerebral aneurism embolization

Other: 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

Outcome Measures

Primary Outcome Measures

Change in blood concentrations of cytokines of the innate immune response [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 Outcome Measures

blood concentrations of cytokines of adaptive and innate immune response [Hour 0 and Hour 24]
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
blood concentrations of cytokines [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)according to the duration of the embolization procedure at H6
blood concentrations of cytokines of adaptive immune response [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 adaptive immune response between patients with cerebral AVM embolization procedures and brain aneurysms embolization between the expected peak at H6 and H0
blood concentrations of cytokines according to the volume of embolizing agent [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)according to the volume of embolizing agent
blood concentrations of cytokines according to the embolizing agent [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)according to the embolizing agent used during the procedure
Cortisol production [Hour 0 and Hour 6]
Comparison of cortisol levels before and after AMV embolization procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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