About this trial
Puerto Rico Embolization of the Middle Meningeal Artery (PREMMA) trial is a multi-center, parallel, prospective, superiority, randomized controlled trial with concealed allocation comparing reoperation rates and neurological outcomes in patients with chronic subdural hematoma that receive treatment via embolization of the middle meningeal artery versus surgical evacuation via burr hole trephination or craniotomy.
Eligibility criteria
Qualifiers
Age ≥ 21
Speak and understand Spanish or English
Resident of Puerto Rico
Glasgow coma scale ≥ 14/15
Disqualifiers
Acute subdural hematoma
Focal, non-hemispheric localization of cSDH
Evidence of other lesions associated with cSDH, such as neoplasms, vascular lesions, or additional epidural, subarachnoid, or parenchymal hemorrhage on non-contrast computed tomography or magnetic resonance imaging
Imaging evidence of skull fracture over the subdural hematoma
Trial design
Treatments tested in this trial
- Embolization of the middle meningeal artery
- Surgical Evacuation via burr hole or craniotomy
Treatment groups
Locations
Sponsors and collaborators
Juan M. Ramos Acevedo
Lead sponsor
University of Puerto Rico
Sponsor institution