Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization

Launched by UNIVERSITY HOSPITAL, BREST · May 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for people with chronic subdural hematomas (CSH), which are collections of blood on the brain's surface that can cause symptoms and may require surgery. Researchers want to see if a minimally invasive procedure called cyanoacrylate embolization can help reduce the chances of these hematomas coming back after treatment, whether patients have surgery or are managed with medication. This trial is important because recurrences can happen in 10 to 20% of cases, and the standard treatments may not always be effective.

To be eligible for the trial, participants must be at least 18 years old and have a CSH that is more than 10 mm in size. They should have health insurance and the CSH must be located on the convex surface of the brain. However, individuals with severe disabilities, certain health issues that could complicate the procedure, or those who are pregnant or breastfeeding cannot participate. If someone joins the trial, they can expect careful monitoring and follow-up as researchers gather data on how well the new treatment works compared to traditional methods.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient with a more than 10 mm CSH confirmed by NCCT
• • CSH localized to convexity
• • Patient aged 18 years or more at the time of the enrollment
• • Patient beneficiary from health insurance
• Exclusion Criteria:
• • Any contraindication as required per angiogram procedure (severe renal failure, allergy...)
• • Pre-existing severe disability resulting in baseline mRS score \> 3
• • Life expectancy of less than 6 months due to another cause than CSH
• • Patient under legal protection or deprived of liberty by a judicial or administrative decision
• • Pregnant or breastfeeding women