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

Launched by REGION SKANE · Feb 24, 2022

Keywords

ClinConnect Summary

The SWEMMA trial is a research study looking at two different ways to treat a condition called chronic subdural hematoma, which is a collection of blood on the brain's surface that can cause symptoms like headaches or confusion. This trial compares a newer method called embolization of the middle meningeal artery, which aims to block the blood flow to the hematoma, against the traditional surgical approach of removing the blood collection from the brain. The goal is to see which method leads to fewer patients needing to have surgery again after the initial treatment.

To be eligible for this trial, participants need to be between 18 and 89 years old and have a confirmed diagnosis of chronic subdural hematoma that hasn't been treated before. They should also be in stable condition, able to understand the study, and provide consent to participate. If you join the trial, you will be randomly assigned to one of the two treatment groups, and you'll be closely monitored by healthcare professionals throughout the process. This study is currently recruiting participants, and both men and women are welcome to apply.

Gender

ALL

Eligibility 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