NCT06466733

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 658 (estimated)
• Sponsor: Juan M. Ramos Acevedo · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Chronic subdural hematoma (cSDH) is a collection of fluid and blood breakdown products that evolves over weeks to months in the subdural space. This condition is more common among people older than 65 years and has been associated with increased use of antithrombotic therapy among this population. The World population is rapidly aging; thus, the investigators expect the number of patients with cSDH will increase. The United Nations World Social Report places Puerto Rico in the 7th place of countries with the largest share of people aged 65 years or over. This pathology burdens healthcare systems; therefore, assessing the feasibility of treatment modalities for cSDH that are less invasive, have lower procedural risks, and have lower recurrence rates that require additional surgical intervention is essential. The standard of care for symptomatic cSDH is the surgical evacuation (SE) of the hematoma, with recurrence rates between 10-30% and surgical rescue indicated for most of these cases. Evacuation of the hematoma effectively relieves its mass effect but does not change the underlying pathophysiologic mechanism. In recent years, embolization of the middle meningeal artery (eMMA) has been shown to decrease the recurrence of chronic subdural hematoma and the need for revision burr hole or craniotomy. The PREMMA trial aims to compare embolization of the middle meningeal artery as stand-alone treatment for chronic subdural hematoma versus the standard of care, surgical evacuation.

Conditions

• Chronic Subdural Hematoma

Interventions

Type	Name	Description
PROCEDURE	Embolization of the middle meningeal artery	Embolization of the middle meningeal artery ipsilateral to the chronic subdural hematoma is performed infusing embolic polyvinyl alcohol (PVA) microparticles.
PROCEDURE	Surgical Evacuation via burr hole or craniotomy	The standard of care for chronic subdural hematoma, burr hole or craniotomy are performed ipsilateral to the lesion.

Timeline

• Start date: 2025-05-01
• Primary completion: 2031-07-01
• Completion: 2032-07-01
• First posted: 2024-06-20
• Last updated: 2025-05-07