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

May 2, 2025 updated by: Juan M. Ramos Acevedo
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

658

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endovascular Embolization
Embolization of the middle meningeal artery
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.
Active Comparator: Surgical Evacuation of Hematoma
Burr hole or craniotomy
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.
Other Names:
  • Craniotomy
  • Burr hole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation
Time Frame: 3 months, 6 months, and 12 months
Number of patients requiring reoperation due to recurrent chronic subdural hematoma.
3 months, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale (mRS)
Time Frame: Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, and 12 months
The modified Rankin Scale (mRS) will assess neurological disability. The scale comprises seven levels, from 0 to 6, with higher scores indicating greater disability, and 6 indicating death.
Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, and 12 months
Glasgow Coma Scale (GCS)
Time Frame: Pre-operative, 24 hours, 2 weeks
The Glasgow coma scale (GCS) will assess consciousness level. GCS score can range from 3 (completely unresponsive) to 15 (completely alert and oriented).
Pre-operative, 24 hours, 2 weeks
Visual Analog Scale (VAS)
Time Frame: Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, 12 months
The visual analog scale (VAS) will assess pain levels. VAS represents the severity of pain from 0 "no pain" to 10 "very severe pain."
Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, 12 months
Quality of life (EQ-5D-5L)
Time Frame: Pre-operative, 2 weeks, 1.5 months, 3 months, 6 months, 12 months
Will be measured with the EuroQol 5 dimensions and 5 levels (EQ-5D-5L) grading scale.
Pre-operative, 2 weeks, 1.5 months, 3 months, 6 months, 12 months
Radiological outcomes
Time Frame: Pre-operative, 24 hours, 3 months, 6 months, 12 months
Will be measured by routine computed tomography compared with pre-operative images.
Pre-operative, 24 hours, 3 months, 6 months, 12 months
Technical success of embolization of the middle meningeal artery (eMMA)
Time Frame: 24 hours
The rate of unsuccessful eMMA due to technical failure or anatomical issues will be recorded.
24 hours
Procedure-related complications
Time Frame: 24 hours, 2 weeks, 1.5 months, 3 months
Any life-threatening event from enrollment to discharge will be recorded.
24 hours, 2 weeks, 1.5 months, 3 months
Adverse events
Time Frame: 24 hours, 2 weeks, 1.5 months, 3 months
Any unintentional injury or complication involving a prolonged stay, disability at discharge, or death caused by healthcare management, not the underlying disease, will be recorded.
24 hours, 2 weeks, 1.5 months, 3 months
Post-operative morbidity
Time Frame: 24 hours, 2 weeks, 1.5 months, 3 months
All surgical and/or medical complications that occur.
24 hours, 2 weeks, 1.5 months, 3 months
Mortality
Time Frame: 24 hours, 2 weeks, 30 days, 1.5 months, 3 months, 6 months, 12 months
The number of participants among the total number of deaths.
24 hours, 2 weeks, 30 days, 1.5 months, 3 months, 6 months, 12 months
Length of stay
Time Frame: From date of randomization until the date of discharge or date of death from any cause while patient is in hospital, whichever came first, assessed up to 90 days
The patient's hospitalization period.
From date of randomization until the date of discharge or date of death from any cause while patient is in hospital, whichever came first, assessed up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juan M. Ramos Acevedo

Investigators

  • Principal Investigator: Juan M Ramos Acevedo, MD, University of Puerto Rico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

July 1, 2031

Study Completion (Estimated)

July 1, 2032

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2305109135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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