An interventional study of Middle Meningeal Artery procedure and Traditional Surgery in Chronic Subdural Hematoma, sponsored by Atlantic Health System. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-19.
Sponsored by Atlantic Health System · Not applicable, Interventional, and Treatment
Chronic Subdural Hematoma (cSDH) is a common hematologic problem particularly in older patients. The purpose of this study is to evaluate the safety and efficacy of middle meningeal artery (MMA) embolization compared to traditional surgical strategies for patients presenting with chronic subdural hematoma (cSDH). Although MMA embolization is minimally-invasive procedure that is routinely used for the treatment of tumors or vascular formations (1), this study investigates the use of an established procedure for a new disease state.
The purpose of the research study is to evaluate the safety and efficacy of a new, less-invasive procedure to treat chronic subdural hematoma (cSDH). A subdural hematoma occurs when blood collects on the brain's surface beneath the skull. Subdural hematomas can be life-threatening. They usually result from a head injury. This study will compare the new procedure to conventional surgical treatment of chronic subdural hematoma (cSDH). The new procedure is called middle meningeal artery embolization (MMA).
Current or conventional treatment of chronic subdural hematoma (cSDH) involves surgery (burr hole drainage and craniotomy) to access and remove the cause of the bleeding that is causing the subdural hematoma.
The new procedure, MMA embolization, involves guiding a catheter that is inserted into a blood vessel to the area of the brain that is supplying blood to the subdural hematoma. Particles or a special type of glue will be released to stop the bleeding that is causing the subdural hematoma. This technique has been used to treat other brain conditions, for example, (to treat tumors or malformation of blood vessels).
99 studies on the registry are indexed under Hematoma, Subdural; 29 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 73 interventional studies indexed under Hematoma, Subdural.
Browse Hematoma, Subdural studies →Atlantic Health System is the lead sponsor of 61 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Middle Meningeal Artery Embolization
Procedure: Middle Meningeal Artery procedure
Craniotomy/Burr hole
Procedure: Traditional Surgery
Seal off the blood supply to the middle meningeal artery to prevent growth of the Subdural Hematoma
Drainage of Subdural Hematoma using Craniotomy or Burr Hole
Change in size of SDH
Changes in size of SDH will be recorded in maximum diameter within 6 months.
Time frame: 6 months
Change in Neurological status
Changes in Neurological status after the procedure and through study completion
Time frame: 6 months
Plan to share: No
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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