Observational Study of Histoacryl Embolization of the Middle Meningeal Artery for Chronic Subdural Hematoma HARMONY

What this Trial Is About

Researchers are evaluating the use of Histoacryl in preventing the recurrence or worsening of chronic subdural hematoma CSDH after embolization of the middle meningeal artery MMA. This observational, prospective, multicenter study aims to provide evidence on the effectiveness of Histoacryl in this specific vascular embolization procedure. The trial is sponsored by Aesculap AG and focuses on patients diagnosed with chronic or recurrent subdural hematoma. Histoacryl is applied using either direct needle puncture, a transcatheter approach, or a transendoscopic approach to perform vascular embolization of the MMA. The study involves monitoring patients before the procedure, at surgery, and during follow-up visits at 3 and 6 months. The treatment phase includes the embolization procedure, while the observational phase tracks outcomes related to hematoma progression or recurrence. Participants will undergo assessments including cognitive evaluations, quality of life questionnaires EQ-5D-5L, and measurements of hematoma thickness and midline brain shift at baseline, discharge, 3 months, and 6 months. Researchers will carefully monitor recurrence or progression of the subdural hematoma within 3 months as the primary outcome. The total follow-up period extends up to approximately 6 months after the procedure, with evaluations to assess safety and efficacy during this time.

Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)