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

Not Applicable

Recruiting

• Conditions: Chronic Subdural Hematoma
• Interventions: Procedure: Standard neurosurgical hematoma evacuation; Procedure: Endovascular treatment of the middle meningeal artery

• Registration Number: NCT05267184
• Lead Sponsor: Region Skane

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.

Study Timeline

• Study First Submitted: 2022-02-24
• Study First Submitted QC: 2022-02-24
• Study First Posted: 2022-03-04
• Study Start: 2022-03-28
• Status Verified: 2023-11
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09
• Primary Completion: 2026-12
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 288

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard neurosurgical hematoma evacuation and drainage	Standard neurosurgical hematoma evacuation	Participants receive standard neurosurgical hematoma evacuation via burr hole or mini craniotomy and post-operative subdural or subgaleal drainage.
Embolization of middle meningeal artery	Endovascular treatment of the middle meningeal artery	Participants receive endovascular treatment with embolization of the middle meningeal artery ipsilaterally to the chronic subdural hematoma(s).

Primary Outcome Measures

Name	Time	Method
Reoperation	3 months	Reoperation rate of CSDH between groups

Secondary Outcome Measures

Name	Time	Method
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)
Procedure related complication rate (Safety)	3 months	Difference in number and severity of complications between endovascular and surgical participants
Technical success rate	24 hours	Rate of technically successful embolizations performed
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
Composite endpoint	3 and 12 months	Death or reoperation

Trial Locations

Locations (4)

Skåne University Hospital; 🇸🇪 Lund, Sweden

Karolinska Hospital; 🇸🇪 Stockholm, Sweden

Sahlgenska University Hospital; 🇸🇪 Gothenburg, Sweden

Norrlands Universitetssjukhus; 🇸🇪 Umeå, Sweden