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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Middle Meningeal Artery Embolization | Experimental | Middle Meningeal Artery Embolization |
|
| Traditional Surgery | Active Comparator | Craniotomy/Burr hole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Middle Meningeal Artery procedure | Procedure | Seal off the blood supply to the middle meningeal artery to prevent growth of the Subdural Hematoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in size of SDH | Changes in size of SDH will be recorded in maximum diameter within 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neurological status | Changes in Neurological status after the procedure and through study completion | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benitez | Contact | 973-285-7800 | rbenitez@ansdocs.com | |
| Elena Lobur, RN | Contact | 908-522-2045 | elena.lobur@atlantichealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Overlook Medical Center | Recruiting | Summit | New Jersey | 07901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36129273 | Derived | Fuentes AM, Khalid SI, Mehta AI. Predictors of Subsequent Intervention After Middle Meningeal Artery Embolization for Treatment of Subdural Hematoma: A Nationwide Analysis. Neurosurgery. 2023 Jan 1;92(1):144-149. doi: 10.1227/neu.0000000000002151. Epub 2022 Sep 21. |
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| Traditional Surgery | Procedure | Drainage of Subdural Hematoma using Craniotomy or Burr Hole |
|
| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |
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