Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorRegion Skane

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Endovascular treatment of the middle meningeal artery
  • Standard neurosurgical hematoma evacuation

Treatment groups

288 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Region Skane

Lead sponsor

Lund University

Collaborator

Sahlgrenska University Hospital

Collaborator

Karolinska University Hospital

Collaborator

Norrlands University Hospital

Collaborator