Chronic Subdural Hematomas, Middle Meningeal Artery Embolization
Conditions
Brief summary
Primary : to evaluate the efficacy of MMAE on resolution and recurrence of hematoma in patients with CSDH. Secondary : evaluate the effect of MMAE on functional outcome, radiological changes, the need to repeat surgery, duration of hospital stay, time for hematoma to resolve.
Detailed description
Chronic subdural hematoma(CSDH) is one of the most common neurosurgical disorders, particularly among older adults, and its incidence continues to increase worldwide because of population aging and the growing use of anticoagulant and antiplatelet medications. The condition usually develops following minor head trauma that results in rupture of bridging veins; however, current evidence suggests that the persistence and enlargement of CSDH are primarily driven by chronic inflammation, angiogenesis, and recurrent microhemorrhages originating from fragile neovascular membranes rather than the initial bleeding event alone. These pathological mechanisms contribute to progressive hematoma expansion, neurological deterioration, and substantial morbidity and mortality if left untreated.Surgical evacuation through burr-hole remains the standard treatment for symptomatic CSDH and is generally associated with rapid neurological improvement. Nevertheless, postoperative recurrence remains a major challenge, with recurrence rates ranging from approximately 8% to 20%, often necessitating repeat surgical intervention. Recurrent hematomas increase healthcare costs, prolong hospitalization, and are associated with poorer functional recovery, particularly in elderly and medically frail patients. Consequently, there has been increasing interest in adjunctive therapies that target the underlying pathophysiology responsible for recurrence rather than simply evacuating the hematoma.Middle meningeal artery embolization (MMAE) has recently emerged as a promising minimally invasive treatment for CSDH. The rationale for MMAE is based on occluding the vascular supply to the outer neomembrane of the hematoma, thereby reducing ongoing inflammatory exudation and recurrent microhemorrhage that sustain hematoma growth. Unlike conventional surgery, which addresses the hematoma itself, embolization targets the biological process responsible for hematoma persistence and recurrence. As a result, MMAE has been investigated both as a standalone therapy for selected patients and as an adjunct to surgical evacuation to reduce postoperative recurrence.MMAE significantly reduces the risk of hematoma recurrence and the need for repeat surgery compared with standard treatment alone, without increasing serious complications or mortality. However, although recurrence outcomes have shown clear improvement, the effect of MMAE on functional recovery, commonly assessed using the Glasgow Coma Scale (GCS).
Interventions
PROCEDUREmiddle meningeal artery embolization
Middle meningeal artery (MMA) embolization is a minimally invasive endovascular procedure designed to treat chronic subdural hematomas by blocking blood flow to the MMA, preventing recurrent bleeding. Under local or general anesthesia, a catheter is inserted through a micro-puncture in the femoral or radial artery and navigated up to the external carotid system into the MMA under real-time fluoroscopic (X-ray) guidance. Angiography is performed to map the arterial anatomy and identify any dangerous anastomoses with the ophthalmic or internal carotid arteries. Once positioned safely, an embolic agent such as liquid embolic systems (e.g., Onyx, n-BCA), liquid-suspended microparticles (PVA), or microcoils is injected into the anterior and posterior branches of the MMA. This occludes the fragile, hypervascular membranes driving the hematoma, allowing the body to naturally reabsorb the collected blood and reducing the need for open surgical evacuation.
Sponsors
Assiut University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Any age. 2. Radiologically confirmed chronic subdural hematoma (CSDH) on CT or MRI either Unilateral or Bilateral CSDH. 3. Patients considered suitable for standard surgical treatment of CSDH. 4. First presentation or recurrent CSDH requiring treatment.
Exclusion criteria
1. Acute subdural hematoma or acute-on-chronic SDH where the acute component is the primary pathology. 2. Acute and severe neurological deterioration. 3. Subdural hematomas secondary to: * Intracranial tumors. * Intracranial infections. 4. Contraindications to angiography or embolization (for the MMAE group), such as: * Severe contrast allergy. * Untreatable coagulopathy. * Severe renal failure precluding contrast administration 5. Severe tortuosity or anatomical variations of the external carotid artery/MMA making catheterization unfeasible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Requiring Additional Surgical Intervention | six months | Composite outcome defined as recurrence of chronic subdural hematoma requiring repeat surgical intervention within 6 months. Recurrence may be identified by radiological enlargement or reaccumulation of the hematoma on CT associated with recurrent or worsening neurological symptoms leading to reoperation. |
Outcome results
None listed