Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response

NCT05621850 | Recruiting

• 1 other identifier: 87RI22_0030 (PROCESS)
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Arterio-venous Malformation

Keywords

Arterio-venous malformation; DMSO; Immune response; Cytokines

Outcome Measures

Primary Outcomes (1)

• Change in blood concentrations of cytokines of the innate immune response

  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

  Hour 0 and Hour 6

Secondary Outcomes (7)

• 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

• blood concentrations of cytokines according to the volume of embolizing agent

  Hour 0 and Hour 6

• blood concentrations of cytokines according to the embolizing agent

  Hour 0 and Hour 6

Study Arms (2)

cerebral AVM embolization

EXPERIMENTAL

Other: Blood sample

cerebral aneurism embolization

OTHER

Other: Blood sample

Interventions

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

cerebral AVM embolization; cerebral aneurism embolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult hospitalized for a planned cerebral embolization

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Limoges University Hospital

Limoges, 87042, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Thomas DAIX, MD

CONTACT

555066983; thomas.daix@chu-limoges.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 18, 2022
• Study Start: December 5, 2022
• Primary Completion: December 5, 2025
• Study Completion: December 5, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)