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).
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
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)
Parallel
Endovascular treatment of the middle meningeal artery
Procedure/SurgeryThe middle meningeal artery on the same side(s) as the chronic subdural hematoma is embolized with liquid embolic agents.
Standard neurosurgical hematoma evacuation
Procedure/SurgeryStandard neurosurgical evacuation of chronic subdural hematoma through burr-hole or mini craniotomy and postoperative subdural or subgaleal drainage.
Reoperation
Reoperation rate of CSDH between groups
Neurological disability
Assessed by the modified Rankin Scale (mRS). Numerical scale with scores between 0 and 6 (0 = no symptoms, 6= death)
Quality of Life (EQ-5D)
Assessed by the EuroQol EQ-5D scale
Residual hematoma volume
Change in hematoma volume from pre-, post operative, and follow up head CT
Technical success rate
Rate of technically successful embolizations performed
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Region Skane
Lead sponsor
Lund University
Collaborator
Sahlgrenska University Hospital
Collaborator
Karolinska University Hospital
Collaborator
Norrlands University Hospital
Collaborator
