Effects of embolization on immune response in cerebral AVM patients
Impact of CErebral Endovascular PROcedures on the Systemic Immune responSe Response
This study is testing how a treatment for brain blood vessel malformations affects the immune system in patients and whether it could increase their risk of infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Limoges Academic / other |
| Locations | 1 site (Limoges) |
| Trial ID | NCT05621850 on ClinicalTrials.gov |
What this trial studies
This study investigates how cerebral embolization procedures for treating arteriovenous malformations (AVMs) affect the immune response in patients. It focuses on the role of Dimethylsulfoxide (DMSO), a solvent used in the embolization process, and its potential impact on cytokine production. Blood samples will be collected from patients at three different time points to analyze changes in cytokine levels using multiplex ELISA techniques. The goal is to understand whether exposure to the embolization implant alters immune regulation and increases the risk of infections like Ventilator Associated Pneumoniae.
Who should consider this trial
Good fit: Ideal candidates are adults hospitalized for planned cerebral embolization of a cerebral arteriovenous malformation.
Not a fit: Patients who are immunosuppressed, have autoimmune diseases, or have had recent hospitalizations for infections or surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients undergoing embolization for cerebral AVMs, potentially reducing infection rates.
How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated that immune responses can be affected by embolization procedures, suggesting potential relevance.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Limoges
- Limoges University Hospital — Limoges, France (Recruiting)
Study contacts
- Study coordinator: Thomas DAIX, MD
- Email: thomas.daix@chu-limoges.fr
- Phone: 555066983
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.