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

Locations

4
Sahlgenska University Hospital41345, Gothenburg Sweden
Skåne University Hospital22185, Lund Sweden
Karolinska Hospital17176, Stockholm Sweden
Norrlands Universitetssjukhus90737, Umeå Sweden

Sponsors and collaborators

Region Skane

Lead sponsor

Lund University

Collaborator

Sahlgrenska University Hospital

Collaborator

Karolinska University Hospital

Collaborator

Norrlands University Hospital

Collaborator