Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06466733
Study type	Interventional
Source	University of Puerto Rico
Contact	Maria M Garcia Perez
Phone	939-417-4432
Email	dra.garcia.neurosx@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	August 2024
Completion date	July 2031

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See also
Status	Clinical Trial	Phase
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Recruiting	`NCT04065113` - Middle Meningeal Artery Embolization for Chronic Subdural Hematoma	N/A
Recruiting	`NCT02938468` - Mgt of Chronic Subdural Hematoma Using Dexamethasone	Phase 2/Phase 3
Completed	`NCT03307395` - Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma	N/A
Terminated	`NCT04502745` - A Study to Evaluate Endoscope-assisted, Minimally-invasive Cortical Access System for Chronic Subdural Evacuation	N/A
Terminated	`NCT03353259` - Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery	Phase 2/Phase 3
Recruiting	`NCT02568124` - Tranexamic Acid in Chronic Subdural Hematomas	Phase 2/Phase 3
Completed	`NCT02282228` - Detecting Chronic Subdural Hematoma With Microwave Technology	N/A
Recruiting	`NCT05143216` - High Concentration Oxygen Therapy for Pneumocephalus in Chronic Subdural Haematoma: A Prospective Observational Study
Active, not recruiting	`NCT04816591` - Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA	N/A
Recruiting	`NCT06401772` - The Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma	N/A
Completed	`NCT06134206` - Burr Hole Ultrasound Study	N/A
Recruiting	`NCT03666949` - General Anesthesia Versus Locoregional Anesthesia for Evacuation of Chronic Subdural Hematoma	N/A
Recruiting	`NCT03280212` - Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma	Phase 3
Completed	`NCT03447327` - Outcome of Single Burr Hole Under Local Anaesthesia in the Management of Chronic Subdural Hematoma	N/A
Recruiting	`NCT05374681` - Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization	N/A
Recruiting	`NCT05267184` - Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma	N/A
Not yet recruiting	`NCT05900557` - Neurologic Deficits and Recovery in Chronic Subdural Hematoma	N/A
Completed	`NCT02757235` - The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma	N/A
Terminated	`NCT02111785` - Dexamethasone Versus Burr Hole Craniostomy for Symptomatic Chronic Subdural Hematoma	Phase 2/Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms