Minimally invasive treatment for chronic subdural hematoma using cyanoacrylate embolization
Official title: 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
Run by University Hospital, Brest · NCT05374681 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 550 (estimated) |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 11 sites (Amiens, France and 10 other locations) |
| Status | Recruiting |
| Started | March 28, 2023 |
| Main results expected | September 28, 2028 |
| Study ends | September 28, 2028 |
| Registry record updated | June 26, 2026 |
| Trial ID | NCT05374681 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While there are ongoing studies on chronic subdural hematomas, the specific use of cyanoacrylate embolization as an adjuvant therapy is relatively novel.
Who can join: the full rules
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 it's running
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CHU Brest
Brest, France, France Recruiting -
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
Show 5 more locations
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CHU Bordeaux
Bordeaux, France Recruiting -
CHU Nancy
Nancy, France Recruiting -
CHU Amiens-Picardie
Amiens, France, France Terminated -
CHU Caen
Caen, France, France Terminated -
CHU Tours
Tours, France, France Terminated
Study contacts
- Study coordinator: jean-Christophe GENTRIC, PhD
- Email: jean-christophe.gentric@chu-brest.fr
- Phone: 0298347520
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Middle Meningeal Artery Embolisation to Prevent Recurrence of Chronic Subdural Hematoma
This study tests whether embolising the middle meningeal artery around the time of hematoma evacuation can reduce recurrence in adults with chronic subdural hematoma.
-
What causes vulnerability in older adults with serious diseases and how it affects care decisions
This study tests how often vulnerability factors appear in older adults with serious illnesses and how these factors influence treatment timing, survival, and quality of life.
-
Coil embolization for unilateral vs bilateral chronic subdural hematomas
This trial tests whether unilateral or bilateral coil-based embolization of the middle meningeal artery helps people with chronic subdural hematoma.
-
Non-Thermal Plasma Used During Surgery to Help Prevent Recurrent Chronic Subdural Hematoma
A randomized trial tests whether applying non-thermal plasma during standard surgery to drain a chronic subdural hematoma can reduce recurrence within 6 months.
-
Enhanced recovery pathway for burr-hole drainage in chronic subdural hematoma patients
This project tests whether an enhanced recovery protocol for adults having burr-hole drainage for chronic subdural hematoma can reduce recurrence and complications compared with past patients.
-
Matched microcatheter and guidewire use for middle meningeal artery embolization in chronic subdural hematoma
This will test whether using a matched Aristotle 14 guidewire and Plato 17 microcatheter during middle meningeal artery embolization works better than surgeons' usual device choices for adults with chronic subdural hematoma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.