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Clinical Trials in Sweden / NCT05267184
Active, not recruiting Not applicable

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

NCT05267184 · tracked via the Priya Life Science Sweden tracker
Sponsor
Region Skane
Phase
Not applicable
Started
2022-03-28
Last updated
2026-09-14

Condition(s) studied

Chronic Subdural Hematoma

Investigational drug(s) / intervention(s)

Endovascular treatment of the middle meningeal arteryStandard neurosurgical hematoma evacuation

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.

Standard neurosurgical hematoma evacuation: Standard neurosurgical evacuation of chronic subdural hematoma through burr-hole or mini craniotomy and postoperative subdural or subgaleal drainage.

Study 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 comparison of embolization of the middle meningeal artery (intervention) with standard neurosurgical hematoma evacuation (control).

Eligibility

Sex
ALL
Min age
18 Years
Max age
89 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Sahlgenska University Hospital Gothenburg Sweden
Skåne University Hospital Lund Sweden
Karolinska Hospital Stockholm Sweden
Norrlands Universitetssjukhus Umeå Sweden

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Other trials for the same condition

Restarting Early Versus Later Anticoagulation for Chronic Subdural Hematoma With Atrial Fibrillation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05267184 on ClinicalTrials.gov ↗ ← All trials in Sweden