An interventional study of Embolization of the middle meningeal artery and Surgical Evacuation via burr hole or craniotomy in Chronic Subdural Hematoma, sponsored by Juan M. Ramos Acevedo. Not yet recruiting. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Juan M. Ramos Acevedo · Not applicable, Interventional, and Treatment
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.
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.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 658 is above the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →This is the only study on the registry with Juan M. Ramos Acevedo as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Embolization of the middle meningeal artery
Procedure: Embolization of the middle meningeal artery
Burr hole or craniotomy
Procedure: Surgical Evacuation via burr hole or craniotomy
Embolization of the middle meningeal artery ipsilateral to the chronic subdural hematoma is performed infusing embolic polyvinyl alcohol (PVA) microparticles.
The standard of care for chronic subdural hematoma, burr hole or craniotomy are performed ipsilateral to the lesion.
Also known as: Burr hole, Craniotomy
Reoperation
Number of patients requiring reoperation due to recurrent chronic subdural hematoma.
Time frame: 3 months, 6 months, and 12 months
Modified Rankin Scale (mRS)
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.
Time frame: Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, and 12 months
Glasgow Coma Scale (GCS)
The Glasgow coma scale (GCS) will assess consciousness level. GCS score can range from 3 (completely unresponsive) to 15 (completely alert and oriented).
Time frame: Pre-operative, 24 hours, 2 weeks
Visual Analog Scale (VAS)
The visual analog scale (VAS) will assess pain levels. VAS represents the severity of pain from 0 "no pain" to 10 "very severe pain."
Time frame: Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, 12 months
Quality of life (EQ-5D-5L)
Will be measured with the EuroQol 5 dimensions and 5 levels (EQ-5D-5L) grading scale.
Time frame: Pre-operative, 2 weeks, 1.5 months, 3 months, 6 months, 12 months
Radiological outcomes
Will be measured by routine computed tomography compared with pre-operative images.
Time frame: Pre-operative, 24 hours, 3 months, 6 months, 12 months
Technical success of embolization of the middle meningeal artery (eMMA)
The rate of unsuccessful eMMA due to technical failure or anatomical issues will be recorded.
Time frame: 24 hours
Procedure-related complications
Any life-threatening event from enrollment to discharge will be recorded.
Time frame: 24 hours, 2 weeks, 1.5 months, 3 months
Adverse events
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.
Time frame: 24 hours, 2 weeks, 1.5 months, 3 months
Post-operative morbidity
All surgical and/or medical complications that occur.
Time frame: 24 hours, 2 weeks, 1.5 months, 3 months
Mortality
The number of participants among the total number of deaths.
Time frame: 24 hours, 2 weeks, 30 days, 1.5 months, 3 months, 6 months, 12 months
Length of stay
The patient's hospitalization period.
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
No study locations are listed for this record.
Plan to share: No
Start is estimated for May 2025; primary completion for Jul 2031, 74 months later.
Of 44 interventional studies with no phase under Hematoma, Subdural, Chronic, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 70. This study's planned 74 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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