Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma
Region Skane
288 participants
Mar 28, 2022
INTERVENTIONAL
Conditions
Summary
The SWEMMA trial is an open, national, multi-center, prospective, randomized (1:1), superiority trial designed to assess impact on reoperation rates for chronic subdural hematoma with a head-to-head comparison of embolization of the middle meningeal artery (intervention) with standard neurosurgical hematoma evacuation (control).
Eligibility
Inclusion Criteria6
- Men and women 18-89 y/o
- Non-contrast Computed Tomography (NCCT)- or Magnetic Resonance Imaging (MRI)- verified, previously unoperated uni- or bilateral cSDH
- Clinical and/or radiological status indicating neurosurgical treatment
- Markwalder Scale score <2
- Glasgow coma Scale score >13
- Able to provide signed informed consent
Exclusion Criteria10
- Acute subdural hematoma
- Focal, non-hemispheric cSDH
- Midline shift >10 mm and/or effaced basal cisterns and/or significant dilatation of one or both lateral ventricle temporal horns and/or incipient uncal herniation
- Structural pathology causing the cSDH (e.g. dural AV-fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt)
- Contraindications to angiography
- Dependency defined as mRS >3
- Life expectancy <6 months
- Comorbidity deemed making follow up impossible
- Participation in other interventional clinical study
- Pregnancy
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Interventions
The middle meningeal artery on the same side(s) as the chronic subdural hematoma is embolized with liquid embolic agents.
Standard neurosurgical evacuation of chronic subdural hematoma through burr-hole or mini craniotomy and postoperative subdural or subgaleal drainage.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05267184