Chronic Subdural Hematoma
Conditions
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 comparison of embolization of the middle meningeal artery (intervention) with standard neurosurgical hematoma evacuation (control).
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 postoperative drainage but recurrence and reoperation rates are as high as 10-30%. Embolization of the middle meningeal artery (EMMA) has been proposed as an adjunct or as sole therapy and initial data suggests markedly reduced reoperation rates. Several randomised trials are currently underway, mostly randomizing with EMMA as an adjunctive to evacuation, or as an alternative to conservative treatment. This trial aims to make a head-to-head comparison of neurosurgical evacuation versus EMMA. Aims: The primary objective of the trial is to compare efficacy of EMMA on rates of reoperation by randomizing patients with CSDH and mild to moderate symptoms to either EMMA or standard neurosurgical evacuation. Secondary objectives include all complication rate, technical success rate, residual hematoma volume at 3 months, neurological functionality and quality of life at 3 and 12 months and composite endpoint of death or reoperation at 3 and 12 months. Method: Patients with previously untreated CSDH admitted to the neurosurgical unit at participating centers with clinical and/or radiological indication for neurosurgical evacuation, mild to moderate symptoms and able to provide informed consent, will be randomized to either standard treatment or EMMA. Immediately after either procedure the participant returns to standard clinical care. At 3 months a CT of the head is performed. A structured telephone interview is held by a treatment-blinded outcomes assessor at 3 months and 12 months, measuring quality of life (EQ-5D) and neurological disability (mRS). Medical records are collected and assessed at 3 months regarding safety measures. Data on reoperation and mortality are collected from the National Board of Health and Welfare and National Cause of Death Registry at 3 months and 12 months.
Interventions
PROCEDUREEndovascular 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.
PROCEDUREStandard neurosurgical hematoma evacuation
Standard neurosurgical evacuation of chronic subdural hematoma through burr-hole or mini craniotomy and postoperative subdural or subgaleal drainage.
Sponsors
Region Skane
Lund University
Sahlgrenska University Hospital
Karolinska University Hospital
Norrlands University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
telephone interview at 3 and 12 months by clinical outcomes assessor blinded to treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation | 3 months | Reoperation rate of CSDH between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurological disability | 3 months and 12 months | Assessed by the modified Rankin Scale (mRS). Numerical scale with scores between 0 and 6 (0 = no symptoms, 6= death) |
| Quality of Life (EQ-5D) | 3 months and 12 months | Assessed by the EuroQol EQ-5D scale |
| Residual hematoma volume | 3 months | Change in hematoma volume from pre-, post operative, and follow up head CT |
| Technical success rate | 24 hours | Rate of technically successful embolizations performed |
| Procedure related complication rate (Safety) | 3 months | Difference in number and severity of complications between endovascular and surgical participants |
| Composite endpoint | 3 and 12 months | Death or reoperation |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORMattias Drake, MD
Skåne University Hospital, Lund University, Lund Sweden
STUDY_DIRECTORJohan Wassélius, MD, PhD
Skåne University Hospital, Lund University, Lund Sweden
Outcome results
None listed