Cerebral Arterio-venous MalformationPROCESSNCT05621850
Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response
A study testing Blood sample in people with Cerebral Arterio-venous Malformation, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Arterio-venous Malformation
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2025to 5 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult hospitalized for a planned cerebral embolization
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Cerebral Arterio-venous Malformation
- Being tested
- Blood sample
- Keywords
- Arterio-venous malformation, DMSO, Immune response, Cytokines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
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
| Study group | Role | What they receive |
|---|---|---|
| cerebral AVM embolization | Experimental | Not described Receives: Other: Blood sample |
| cerebral aneurism embolization | Other | Not described Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Hour 0 and Hour 6
Secondary outcomes (7)
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
Measured: Hour 0 and Hour 24
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
Measured: Hour 6
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
Measured: Hour 0 and Hour 6
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
Measured: Hour 0 and Hour 6
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
Measured: Hour 0 and Hour 6
Cortisol production
Comparison of cortisol levels before and after AMV embolization procedure
Measured: Hour 0 and Hour 6
lymphocyte subpopulations differences
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
Measured: Hour 24 and Hour 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start25 Jul 2025
- Primary completion5 Dec 2025
- Study completion5 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Arterio-venous MalformationStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621850
- Sponsor's protocol ID
- 87RI22_0030 (PROCESS)
- Acronym
- PROCESS
- Status last verified
- Jun 2026
- First submitted
- 28 Oct 2022
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response
- ClinicalTrials.gov ID
- NCT05621850
- Acronym / sponsor ID
- PROCESS / 87RI22_0030 (PROCESS)
- Conditions
- Cerebral Arterio-venous Malformation
- Keywords
- Arterio-venous malformation, DMSO, Immune response, Cytokines
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cerebral AVM embolization | Experimental | Other: Blood sample |
| cerebral aneurism embolization | Other | Other: Blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult hospitalized for a planned cerebral embolization
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleBased on supplementary blood sampled before embolization procedure and 6 hours and 24 hours after we will be analyzed cytokines concentration (Elisa test) and cortisol | Other | cerebral AVM embolization, cerebral aneurism embolization |
Primary outcome
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
7 secondary outcomes
blood concentrations of cytokines of adaptive and innate immune response
Time frame: Hour 0 and Hour 24
blood concentrations of cytokines
Time frame: Hour 6
blood concentrations of cytokines of adaptive immune response
Time frame: Hour 0 and Hour 6
blood concentrations of cytokines according to the volume of embolizing agent
Time frame: Hour 0 and Hour 6
blood concentrations of cytokines according to the embolizing agent
Time frame: Hour 0 and Hour 6
Cortisol production
Time frame: Hour 0 and Hour 6
lymphocyte subpopulations differences
Time frame: Hour 24 and Hour 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Cerebral Arterio-venous Malformation, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood concentrations of cytokines of the innate immune response (time frame: Hour 0 and Hour 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.