Status:
RECRUITING
Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma
Lead Sponsor:
Region Skane
Collaborating Sponsors:
Lund University
Sahlgrenska University Hospital
Conditions:
Chronic Subdural Hematoma
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
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 c...
Detailed Description
Introduction: Chronic subdural hematoma (CSDH) is one of the most common neurosurgical disorders and the incidence is rising. The mainstay of treatment is neurosurgical hematoma evacuation followed by...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT05267184
Start Date
March 28 2022
End Date
March 1 2027
Last Update
April 9 2024
Active Locations (4)
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1
Sahlgenska University Hospital
Gothenburg, Sweden, 41345
2
Skåne University Hospital
Lund, Sweden, 22185
3
Karolinska Hospital
Stockholm, Sweden, 17176
4
Norrlands Universitetssjukhus
Umeå, Sweden, 90737