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

University of Limoges (UL)

Status: Enrolling

Conditions: Cerebral Arterio-venous Malformation

Treatments: Other: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT05621850

87RI22_0030 (PROCESS)

Details and patient eligibility

About

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.

Full 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

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

cerebral AVM embolization

Experimental group

Treatment:

Other: Blood sample

cerebral aneurism embolization

Other group

Treatment:

Other: Blood sample