Minimally invasive treatment for chronic subdural hematoma using cyanoacrylate embolization
LEADH: Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization : Liquid Embolic Agent for the Treatment of Chronic subDural Hematoma a Randomized Control Study
This study is testing if adding a new, less invasive treatment using glue to standard surgery can help people with chronic subdural hematoma have better outcomes and lower chances of the condition coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 550 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 11 sites (Amiens, France and 10 other locations) |
| Trial ID | NCT05374681 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of cyanoacrylate embolization as an adjuvant therapy for patients with chronic subdural hematoma (CSH) requiring surgical intervention. Participants will be divided into two groups: one receiving standard surgical management with additional embolization of the middle meningeal artery, and the other receiving only standard surgical management. The study aims to assess the recurrence rates of CSH and overall patient outcomes using specific scoring systems at two and six months post-treatment. The trial is designed to provide insights into the effectiveness of this minimally invasive approach compared to conventional methods.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a chronic subdural hematoma greater than 10 mm localized to the convexity of the brain.
Not a fit: Patients with severe pre-existing disabilities, life expectancy under six months, or contraindications to angiogram procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the recurrence of chronic subdural hematomas and improve patient outcomes.
How similar studies have performed: While there are ongoing studies on chronic subdural hematomas, the specific use of cyanoacrylate embolization as an adjuvant therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 ≥ 4, 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 * Vulnerable persons unable to give consent
Where this trial is running
Amiens, France and 10 other locations
- CHU Amiens-Picardie — Amiens, France, France (Terminated)
- CHU Brest — Brest, France, France (Recruiting)
- CHU Caen — Caen, France, France (Terminated)
- Hôpital Henri Mondor — Créteil, France, France (Recruiting)
- CHU Nantes — Nantes, France, France (Recruiting)
- CHU Nice — Nice, France, France (Recruiting)
- Hôpital Pitié Salpêtrière — Paris, France, France (Recruiting)
- Hôpital Fondation Rothschild — Paris, France, France (Recruiting)
- CHU Tours — Tours, France, France (Terminated)
- CHU Bordeaux — Bordeaux, France (Recruiting)
- CHU Nancy — Nancy, France (Recruiting)
Study contacts
- Study coordinator: jean-Christophe GENTRIC, PhD
- Email: jean-christophe.gentric@chu-brest.fr
- Phone: 0298347520
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.