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

Recruiting now · Not applicable

Conditions studied: Chronic Subdural Hematoma

In brief

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).

Key facts

Study ID

NCT05267184

Run by

Region Skane

People needed

288

Starts

2022-03-28

Expected to finish

2027-03-01

Last updated by the study team

2024-04-09

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Skåne University Hospital — Lund, Sweden (enrolling)
• Norrlands Universitetssjukhus — Umeå, Sweden (enrolling)
• Sahlgenska University Hospital — Gothenburg, Sweden
• Karolinska Hospital — Stockholm, Sweden

Full record on ClinicalTrials.gov

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