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

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).

Study Overview

• Status: Recruiting
• Conditions: Chronic Subdural Hematoma
• Intervention / Treatment: Procedure: Endovascular treatment of the middle meningeal artery; Procedure: Standard neurosurgical hematoma evacuation

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 Type: Interventional
• Enrollment (Estimated): 288
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Åke Holmberg; Phone Number: +46739660740; Email: ake.holmberg@regionstockholm.se
• Study Contact Backup: Name: Johan Wassélius, MD, PhD; Email: johan.wasselius@gmail.com

Study Locations

• Sweden
  • Gothenburg, Sweden, 41345
    • Not yet recruiting
    • Sahlgenska University Hospital
    • Contact: Erik Ceder, MD, PhD; Email: erik.ceder@vgregion.se
    • Contact: Magnus Tisell, MD, PhD; Email: magnus.tisell@gu.se
    • Principal Investigator: Magnus Tisell, MD, PhD
    • Sub-Investigator: Andreas Bartley, MD
  • Lund, Sweden, 22185
    • Recruiting
    • Skane University Hospital
    • Contact: Åke Holmberg; Phone Number: +46739660740; Email: ake.holmberg@regionstockholm.se
  • Stockholm, Sweden, 17176
    • Not yet recruiting
    • Karolinska hospital
    • Contact: Fabian Arnberg, MD, PhD; Email: fabian.arnberg@regionstockholm.se
    • Contact: Jiri Bartek, MD, PhD; Email: jiri.bartek@ki.se
    • Principal Investigator: Fabian Arnberg, MD, PhD
  • Umeå, Sweden, 90737
    • Recruiting
    • Norrlands universitetssjukhus
    • Contact: Peter Lindvall, MD, PhD; Email: Peter.Lindvall@regionvasterbotten.se
    • Contact: Alexander Henze, MD; Email: Alexander.Henze@regionvasterbotten.se
    • Principal Investigator: Peter Lindvall, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Embolization of middle meningeal artery; Participants receive endovascular treatment with embolization of the middle meningeal artery ipsilaterally to the chronic subdural hematoma(s).	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.
Active Comparator: Standard neurosurgical hematoma evacuation and drainage; Participants receive standard neurosurgical hematoma evacuation via burr hole or mini craniotomy and post-operative subdural or subgaleal drainage.	Procedure: Standard neurosurgical hematoma evacuation; Standard neurosurgical evacuation of chronic subdural hematoma through burr-hole or mini craniotomy and postoperative subdural or subgaleal drainage.; Other Names: burr-hole, mini craniotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperation	Reoperation rate of CSDH between groups	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Quality of Life (EQ-5D)	Assessed by the EuroQol EQ-5D scale	3 months and 12 months
Residual hematoma volume	Change in hematoma volume from pre-, post operative, and follow up head CT	3 months
Technical success rate	Rate of technically successful embolizations performed	24 hours
Procedure related complication rate (Safety)	Difference in number and severity of complications between endovascular and surgical participants	3 months
Composite endpoint	Death or reoperation	3 and 12 months

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Karolinska University Hospital; Lund University; Sahlgrenska University Hospital, Sweden; Norrlands University Hospital
• Investigators: Principal Investigator: Mattias Drake, MD, Skåne University Hospital, Lund University, Lund Sweden; Study Director: Johan Wassélius, MD, PhD, Skåne University Hospital, Lund University, Lund Sweden

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Chronic Disease; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic
• Other Study ID Numbers: 2021/02670

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No