Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma Trial (PREMMA)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorJuan M. Ramos Acevedo

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

658 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Juan M. Ramos Acevedo

Lead sponsor

University of Puerto Rico

Sponsor institution