Compares treatment options for Chronic Subdural Hematoma
Official title Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma
ClinicalTrials.gov ID: NCT05267184
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- 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
You likely can't join if
- 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...
- Structural pathology causing the cSDH (e.g. dural AV-fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt)
- Contraindications to angiography
- Dependency defined as mRS \>3
See the full eligibility criteria
- 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
- 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 treatment clinical study
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Gothenburg, Sweden
- Lund, Sweden
- Stockholm, Sweden
- Umeå, Sweden
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gothenburg, Sweden; Lund, Sweden; Stockholm, Sweden; Umeå, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.