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NCT Number: NCT05621850

Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cerebral Arterio-venous Malformation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Limoges University Hospital

Limoges, 87042, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

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

Primary outcomes

  1. 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

  1. blood concentrations of cytokines of adaptive and innate immune response

    Time frame: 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

  2. blood concentrations of cytokines

    Time frame: 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

  3. blood concentrations of cytokines of adaptive 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 adaptive immune response between patients with cerebral AVM embolization procedures and brain aneurysms embolization between the expected peak at H6 and H0

  4. blood concentrations of cytokines according to the volume of embolizing agent

    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)according to the volume of embolizing agent

  5. blood concentrations of cytokines according to the embolizing agent

    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)according to the embolizing agent used during the procedure

  6. Cortisol production

    Time frame: Hour 0 and Hour 6

    Comparison of cortisol levels before and after AMV embolization procedure

  7. lymphocyte subpopulations differences

    Time frame: Hour 24 and Hour 0

    Measurement 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

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: PROCESS

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 18, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.