Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466733
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-05-15
Brief Title:
Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma Trial PREMMA
Sponsor:
Juan M Ramos Acevedo
Organization:
University of Puerto Rico
Study Overview
Official Title:
Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma Trial PREMMA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREMMA
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None