Clinical trial Recruiting at 8 sites Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment550 (estimated)
SponsorUniversity Hospital, Brest
Academic / other
Locations11 sites (Amiens, France and 10 other locations)
StatusRecruiting
StartedMarch 28, 2023
Main results expectedSeptember 28, 2028
Study endsSeptember 28, 2028
Registry record updatedJune 26, 2026
Trial IDNCT05374681 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.