Clinical trial NCT05267184: Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma
Official title: Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Subdural Hematoma
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
name: Sahlgrenska University Hospital
name: Karolinska University Hospital
name: Norrlands University Hospital
First posted: 2022-03-04
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reoperation
timeFrame: 3 months
Secondary outcomes:
measure: Neurological disability
timeFrame: 3 months and 12 months
measure: Quality of Life (EQ-5D)
timeFrame: 3 months and 12 months
measure: Residual hematoma volume
timeFrame: 3 months
measure: Technical success rate
timeFrame: 24 hours
measure: Procedure related complication rate (Safety)
timeFrame: 3 months
measure: Composite endpoint
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgenska University Hospital
city: Lund
country: Sweden
facility: Skåne University Hospital
city: Stockholm
country: Sweden
facility: Karolinska Hospital
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus
Study officials:
affiliation: Skåne University Hospital, Lund University, Lund Sweden
name: Mattias Drake, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skåne University Hospital, Lund University, Lund Sweden
name: Johan Wassélius, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Drake M, Ullberg T, Nittby H, Marklund N, Wasselius J. Swedish trial on embolization of middle meningeal artery versus surgical evacuation in chronic subdural hematoma (SWEMMA)-a national 12-month multi-center randomized controlled superiority trial with parallel group assignment, open treatment allocation and blinded clinical outcome assessment. Trials. 2022 Nov 8;23(1):926. doi: 10.1186/s13063-022-06842-4.