Study of Cyanoacrylate Embolization Added to Standard Medical or Surgical Care for Adults with Chronic Subdural Hematoma

What this Trial Is About

Chronic subdural hematomas CSH involve blood collecting in the space under the dura mater of the brain. This condition is increasingly common among adults, especially due to the widespread use of blood-thinning medications in older populations. Symptomatic CSH or those causing significant pressure are treated surgically, but recurrence rates remain high. Conservative medical management is used for less severe cases, though many still require surgery. The study evaluates whether embolization of the middle meningeal artery MMA with cyanoacrylates can reduce CSH recurrence in both surgical and medical management contexts compared to standard care. Participants will be assigned to one of four groups medical treatment alone, surgical treatment alone, medical treatment plus MMA embolization, or surgical treatment plus MMA embolization. MMA embolization is performed using cyanoacrylates via femoral or radial arterial access under local anesthesia or conscious sedation. Surgical and medical management decisions are left to the treating neurosurgeons discretion. Primary and secondary outcomes will be assessed at around 2 months and 6 months after treatment, including clinical scores and imaging measures. During the study, participants will undergo clinical evaluations including mRS and RACE scores, as well as imaging to measure hematoma volume and thickness using CT scans. The trial monitors recurrence rates, symptomatic CSH events, need for secondary surgery, embolization success, and complications over a 6-month follow-up. The total study duration extends to September 2028. This research aims to provide evidence on the effectiveness of cyanoacrylate MMA embolization as an additional therapy for CSH management.

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