Efficacy of a Minimally Invasive Therapy Adjuvant to Standard Care by Cyanoacrylate Embolization for Chronic Subdural Hematoma

What this Trial Is About

Chronic subdural hematomas (CSH) involve blood collecting in the space beneath the dura mater of the brain and are increasingly common among adults, partly due to the rising use of blood-thinning medications in older populations. This research evaluates whether adding cyanoacrylate embolization, a minimally invasive procedure targeting the middle meningeal artery, can reduce the recurrence of CSH compared with standard medical or surgical care. The study addresses a significant health problem where current treatments have notable rates of recurrence and therapeutic failure. Participants will be assigned to one of four groups: medical treatment alone, surgical treatment alone, medical treatment combined with embolization, or surgical treatment combined with embolization. Embolization involves blocking the middle meningeal artery using cyanoacrylates delivered via catheter through femoral or radial arteries, usually under local anesthesia or conscious sedation. Surgical and medical management will follow usual neurosurgical practices with the indication determined by the neurosurgeon. The trial includes primary and secondary assessments at around 2 months and 6 months after treatment. During the study, participants will undergo clinical evaluations including the modified Rankin Scale (mRS) and RACE score to assess neurological status. Imaging will be used to measure hematoma volume and thickness. Researchers will track recurrence rates, symptomatic CSH, need for additional surgery, embolization success, and complications. The total follow-up period extends to six months, during which safety and clinical outcomes will be closely monitored to evaluate the potential benefits of adding embolization to standard care.

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