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

Chronic Subdural Hematoma Clinical Trial

— SWEMMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05267184
• Other study ID #: 2021/02670
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: March 2027

Study information

• Verified date: November 2023
• Source: Region Skane
• Contact: Åke Holmberg
• Phone: +46739660740
• Email: ake.holmberg[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: March 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Procedure:
• Endovascular 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.
• Standard neurosurgical hematoma evacuation
Standard neurosurgical evacuation of chronic subdural hematoma through burr-hole or mini craniotomy and postoperative subdural or subgaleal drainage.

Locations

Country	Name	City	State
Sweden	Sahlgenska University Hospital	Gothenburg
Sweden	Skåne University Hospital	Lund
Sweden	Karolinska Hospital	Stockholm
Sweden	Norrlands Universitetssjukhus	Umeå

Sponsors (5)

Lead Sponsor	Collaborator
Region Skane	Karolinska University Hospital, Lund University, Norrlands University Hospital, Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation	Reoperation rate of CSDH between groups	3 months
Secondary	Neurological disability	Assessed by the modified Rankin Scale (mRS). Numerical scale with scores between 0 and 6 (0 = no symptoms, 6= death)	3 months and 12 months
Secondary	Quality of Life (EQ-5D)	Assessed by the EuroQol EQ-5D scale	3 months and 12 months
Secondary	Residual hematoma volume	Change in hematoma volume from pre-, post operative, and follow up head CT	3 months
Secondary	Technical success rate	Rate of technically successful embolizations performed	24 hours
Secondary	Procedure related complication rate (Safety)	Difference in number and severity of complications between endovascular and surgical participants	3 months
Secondary	Composite endpoint	Death or reoperation	3 and 12 months