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Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response

Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05621850
Acronym
PROCESS
Enrollment
78
Registered
2022-11-18
Start date
2025-07-25
Completion date
2026-12-05
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Arterio-venous Malformation

Keywords

Arterio-venous malformation, DMSO, Immune response, Cytokines

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

Interventions

OTHERBlood 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

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Change in blood concentrations of cytokines of the innate immune responseHour 0 and Hour 6Compare 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

MeasureTime frameDescription
blood concentrations of cytokines of adaptive and innate immune responseHour 0 and Hour 24Compare 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 cytokinesHour 6Compare 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 responseHour 0 and Hour 6Compare 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 agentHour 0 and Hour 6Compare 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 agentHour 0 and Hour 6Compare 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 productionHour 0 and Hour 6Comparison of cortisol levels before and after AMV embolization procedure
lymphocyte subpopulations differencesHour 24 and Hour 0Measurement of differences in lymphocyte subpopulations in patients with cAVM embolization procedure and cerebral aneurysm between the expected peak H24 and H0 in 10 patients in each arm

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026