RECRUITINGINTERVENTIONAL
Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma
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).
Who May Be Eligible (Plain English)
Who May Qualify:
1. Men and women 18-89 y/o
2. Non-contrast Computed Tomography (NCCT)- or Magnetic Resonance Imaging (MRI)- verified, previously unoperated uni- or bilateral cSDH
3. Clinical and/or radiological status indicating neurosurgical treatment
4. Markwalder Scale score \<2
5. Glasgow coma Scale score \>13
6. Able to provide signed willing to sign a consent form
Who Should NOT Join This Trial:
1. Acute subdural hematoma
2. Focal, non-hemispheric cSDH
3. 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
4. Structural pathology causing the cSDH (e.g. dural AV-fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt)
5. Contraindications to angiography
6. Dependency defined as mRS \>3
7. Life expectancy \<6 months
8. Comorbidity deemed making follow up impossible
9. Participation in other interventional clinical study
10. Pregnancy
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Men and women 18-89 y/o
2. Non-contrast Computed Tomography (NCCT)- or Magnetic Resonance Imaging (MRI)- verified, previously unoperated uni- or bilateral cSDH
3. Clinical and/or radiological status indicating neurosurgical treatment
4. Markwalder Scale score \<2
5. Glasgow coma Scale score \>13
6. Able to provide signed informed consent
Exclusion Criteria:
1. Acute subdural hematoma
2. Focal, non-hemispheric cSDH
3. 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
4. Structural pathology causing the cSDH (e.g. dural AV-fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt)
5. Contraindications to angiography
6. Dependency defined as mRS \>3
7. Life expectancy \<6 months
8. Comorbidity deemed making follow up impossible
9. Participation in other interventional clinical study
10. Pregnancy
Treatments Being Tested
PROCEDURE
Endovascular treatment of the middle meningeal artery
The middle meningeal artery on the same side(s) as the chronic subdural hematoma is embolized with liquid embolic agents.
PROCEDURE
Standard neurosurgical hematoma evacuation
Standard neurosurgical evacuation of chronic subdural hematoma through burr-hole or mini craniotomy and postoperative subdural or subgaleal drainage.
Locations (4)
Sahlgenska University Hospital
Gothenburg, Sweden
Skåne University Hospital
Lund, Sweden
Karolinska Hospital
Stockholm, Sweden
Norrlands Universitetssjukhus
Umeå, Sweden