Comparing two treatments for chronic subdural hematoma
Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma
This study is testing whether a new treatment using a specific artery embolization can help people with chronic subdural hematoma recover better and have fewer complications compared to the usual surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 288 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 4 sites (Gothenburg and 3 other locations) |
| Trial ID | NCT05267184 on ClinicalTrials.gov |
What this trial studies
The SWEMMA trial is a national, multi-center, prospective, randomized trial that compares the effectiveness of embolization of the middle meningeal artery (EMMA) against standard neurosurgical hematoma evacuation in patients with chronic subdural hematoma (CSDH). This trial aims to determine which treatment results in lower reoperation rates and better overall outcomes, including complications and quality of life. Patients with mild to moderate symptoms and verified CSDH will be randomly assigned to one of the two treatment groups. The study will also assess neurological functionality and residual hematoma volume at specified follow-up intervals.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-89 with previously untreated chronic subdural hematoma and mild to moderate symptoms.
Not a fit: Patients with acute subdural hematoma or significant comorbidities that affect follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could significantly reduce the need for reoperations in patients with chronic subdural hematoma.
How similar studies have performed: While several studies are exploring embolization techniques, this trial's direct head-to-head comparison of EMMA and standard evacuation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gothenburg and 3 other locations
- Sahlgenska University Hospital — Gothenburg, Sweden (Not_yet_recruiting)
- Skåne University Hospital — Lund, Sweden (Recruiting)
- Karolinska Hospital — Stockholm, Sweden (Not_yet_recruiting)
- Norrlands Universitetssjukhus — Umeå, Sweden (Recruiting)
Study contacts
- Principal investigator: Mattias Drake, MD — Skåne University Hospital, Lund University, Lund Sweden
- Study coordinator: Åke Holmberg
- Email: ake.holmberg@regionstockholm.se
- Phone: +46739660740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.