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

NCT ID: NCT06466733

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 658 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2032-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Endovascular Embolization

Embolization of the middle meningeal artery

Group Type: EXPERIMENTAL

Embolization of the middle meningeal artery

Intervention Type: PROCEDURE

Embolization of the middle meningeal artery ipsilateral to the chronic subdural hematoma is performed infusing embolic polyvinyl alcohol (PVA) microparticles.

Surgical Evacuation of Hematoma

Burr hole or craniotomy

Group Type: ACTIVE_COMPARATOR

Surgical Evacuation via burr hole or craniotomy

Intervention Type: PROCEDURE

The standard of care for chronic subdural hematoma, burr hole or craniotomy are performed ipsilateral to the lesion.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Burr hole; Craniotomy

Eligibility Criteria

Inclusion Criteria

• Age ≥ 21
• Speak and understand Spanish or English
• Resident of Puerto Rico
• Glasgow coma scale ≥ 14/15
• Presence of cSDH on non-contrast computed tomography (NCCT) or magnetic resonance imaging (MRI)
• Neurological indication for treatment of cSDH (Markwalder scale ≤ 2)
• No previous surgical or endovascular treatment for symptomatic cSDH
• Signed informed consent for participation in the study by the patient or legally authorized representative

Exclusion Criteria

• 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
• Presence of any cerebrospinal fluid (CSF) shunt
• Imaging evidence of midline shift ≥ 10 mm
• Imaging evidence of basal cistern effacement
• Imaging evidence of dilatation of lateral ventricles
• Imaging evidence of uncal herniation
• Modified Rankin scale ≥ 3 before developing symptoms associated with cSDH
• Contraindications for angiography (i.e., complex anatomy or kidney failure)
• Comorbidity making follow-up impossible
• Pregnancy
• Vulnerable patients, including homeless patients, incarcerated patients, and mentally ill patients without appropriate medical decision-making proxies that the physician believes are incapable of appropriately assessing the risks of the procedure
• Absence of medical insurance

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juan M. Ramos Acevedo

OTHER

Sponsor Role: lead

Responsible Party

Juan M. Ramos Acevedo

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Juan M Ramos Acevedo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Puerto Rico

Central Contacts

Maria M Garcia Perez

Role: CONTACT

dra.garcia.neurosx@gmail.com

939-417-4432

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Other Identifiers

2305109135

Identifier Type: -

Identifier Source: org_study_id