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

Primary Purpose

Cerebral Arterio-venous Malformation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cerebral Arterio-venous Malformation focused on measuring Arterio-venous malformation, DMSO, Immune response, Cytokines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Limoges University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

cerebral AVM embolization

cerebral aneurism embolization

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

blood concentrations of cytokines of adaptive and 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 adaptive and innate immune response between patients with cerebral AVM embolization procedures and brain aneurysms embolization
blood concentrations of cytokines
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
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
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
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
Comparison of cortisol levels before and after AMV embolization procedure

Full Information

First Posted
October 28, 2022
Last Updated
December 23, 2022
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT05621850
Brief Title
Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response
Acronym
PROCESS
Official Title
Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
June 5, 2024 (Anticipated)
Study Completion Date
June 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Arterio-venous Malformation
Keywords
Arterio-venous malformation, DMSO, Immune response, Cytokines

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cerebral AVM embolization
Arm Type
Experimental
Arm Title
cerebral aneurism embolization
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
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 Outcome Measure Information:
Title
Change in blood concentrations of cytokines of the innate immune response
Description
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
Time Frame
Hour 0 and Hour 6
Secondary Outcome Measure Information:
Title
blood concentrations of cytokines of adaptive and innate immune response
Description
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
Time Frame
Hour 0 and Hour 24
Title
blood concentrations of cytokines
Description
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
Time Frame
Hour 6
Title
blood concentrations of cytokines of adaptive immune response
Description
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
Time Frame
Hour 0 and Hour 6
Title
blood concentrations of cytokines according to the volume of embolizing agent
Description
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
Time Frame
Hour 0 and Hour 6
Title
blood concentrations of cytokines according to the embolizing agent
Description
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
Time Frame
Hour 0 and Hour 6
Title
Cortisol production
Description
Comparison of cortisol levels before and after AMV embolization procedure
Time Frame
Hour 0 and Hour 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas DAIX, MD
Phone
555066983
Ext
+33
Email
thomas.daix@chu-limoges.fr
Facility Information:
Facility Name
Limoges University Hospital
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas DAIX, MD
Email
thomas.daix@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
Thomas DAIX, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response

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