Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma (SWEMMA)
Primary Purpose
Chronic Subdural Hematoma
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Endovascular treatment of the middle meningeal artery
Standard neurosurgical hematoma evacuation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Subdural Hematoma
Eligibility Criteria
Inclusion Criteria:
- Men and women 18-89 y/o
- Non-contrast Computed Tomography (NCCT)- or Magnetic Resonance Imaging (MRI)- verified, previously unoperated uni- or bilateral cSDH
- Clinical and/or radiological status indicating neurosurgical treatment
- Markwalder Scale score <2
- Glasgow coma Scale score >13
- Able to provide signed informed consent
Exclusion Criteria:
- Acute subdural hematoma
- Focal, non-hemispheric cSDH
- 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
- Structural pathology causing the cSDH (e.g. dural AV-fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt)
- Contraindications to angiography
- Dependency defined as mRS >3
- Life expectancy <6 months
- Comorbidity deemed making follow up impossible
- Participation in other interventional clinical study
- Pregnancy
Sites / Locations
- Sahlgenska University Hospital
- Skåne University HospitalRecruiting
- Karolinska Hospital
- Norrlands Universitetssjukhus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Embolization of middle meningeal artery
Standard neurosurgical hematoma evacuation and drainage
Arm Description
Participants receive endovascular treatment with embolization of the middle meningeal artery ipsilaterally to the chronic subdural hematoma(s).
Participants receive standard neurosurgical hematoma evacuation via burr hole or mini craniotomy and post-operative subdural or subgaleal drainage.
Outcomes
Primary Outcome Measures
Reoperation
Reoperation rate of CSDH between groups
Secondary Outcome Measures
Neurological disability
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)
Assessed by the EuroQol EQ-5D scale
Residual hematoma volume
Change in hematoma volume from pre-, post operative, and follow up head CT
Technical success rate
Rate of technically successful embolizations performed
Procedure related complication rate (Safety)
Difference in number and severity of complications between endovascular and surgical participants
Composite endpoint
Death or reoperation
Full Information
NCT ID
NCT05267184
First Posted
February 24, 2022
Last Updated
April 22, 2022
Sponsor
Region Skane
Collaborators
Lund University, Sahlgrenska University Hospital, Sweden, Karolinska University Hospital, Norrlands University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05267184
Brief Title
Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma
Acronym
SWEMMA
Official Title
Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
Collaborators
Lund University, Sahlgrenska University Hospital, Sweden, Karolinska University Hospital, Norrlands University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
telephone interview at 3 and 12 months by clinical outcomes assessor blinded to treatment.
Allocation
Randomized
Enrollment
288 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Embolization of middle meningeal artery
Arm Type
Experimental
Arm Description
Participants receive endovascular treatment with embolization of the middle meningeal artery ipsilaterally to the chronic subdural hematoma(s).
Arm Title
Standard neurosurgical hematoma evacuation and drainage
Arm Type
Active Comparator
Arm Description
Participants receive standard neurosurgical hematoma evacuation via burr hole or mini craniotomy and post-operative subdural or subgaleal drainage.
Intervention Type
Procedure
Intervention Name(s)
Endovascular treatment of the middle meningeal artery
Intervention Description
The middle meningeal artery on the same side(s) as the chronic subdural hematoma is embolized with liquid embolic agents.
Intervention Type
Procedure
Intervention Name(s)
Standard neurosurgical hematoma evacuation
Other Intervention Name(s)
burr-hole, mini craniotomy
Intervention Description
Standard neurosurgical evacuation of chronic subdural hematoma through burr-hole or mini craniotomy and postoperative subdural or subgaleal drainage.
Primary Outcome Measure Information:
Title
Reoperation
Description
Reoperation rate of CSDH between groups
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Neurological disability
Description
Assessed by the modified Rankin Scale (mRS). Numerical scale with scores between 0 and 6 (0 = no symptoms, 6= death)
Time Frame
3 months and 12 months
Title
Quality of Life (EQ-5D)
Description
Assessed by the EuroQol EQ-5D scale
Time Frame
3 months and 12 months
Title
Residual hematoma volume
Description
Change in hematoma volume from pre-, post operative, and follow up head CT
Time Frame
3 months
Title
Technical success rate
Description
Rate of technically successful embolizations performed
Time Frame
24 hours
Title
Procedure related complication rate (Safety)
Description
Difference in number and severity of complications between endovascular and surgical participants
Time Frame
3 months
Title
Composite endpoint
Description
Death or reoperation
Time Frame
3 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women 18-89 y/o
Non-contrast Computed Tomography (NCCT)- or Magnetic Resonance Imaging (MRI)- verified, previously unoperated uni- or bilateral cSDH
Clinical and/or radiological status indicating neurosurgical treatment
Markwalder Scale score <2
Glasgow coma Scale score >13
Able to provide signed informed consent
Exclusion Criteria:
Acute subdural hematoma
Focal, non-hemispheric cSDH
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
Structural pathology causing the cSDH (e.g. dural AV-fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt)
Contraindications to angiography
Dependency defined as mRS >3
Life expectancy <6 months
Comorbidity deemed making follow up impossible
Participation in other interventional clinical study
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Åke Holmberg
Phone
+46739660740
Email
ake.holmberg@regionstockholm.se
First Name & Middle Initial & Last Name or Official Title & Degree
Johan Wassélius, MD, PhD
Email
johan.wasselius@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mattias Drake, MD
Organizational Affiliation
Skåne University Hospital, Lund University, Lund Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Johan Wassélius, MD, PhD
Organizational Affiliation
Skåne University Hospital, Lund University, Lund Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Sahlgenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erik Ceder, MD, PhD
Email
erik.ceder@vgregion.se
First Name & Middle Initial & Last Name & Degree
Magnus Tisell, MD, PhD
Email
magnus.tisell@gu.se
First Name & Middle Initial & Last Name & Degree
Magnus Tisell, MD, PhD
First Name & Middle Initial & Last Name & Degree
Andreas Bartley, MD
Facility Name
Skåne University Hospital
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Åke Holmberg
Phone
+46739660740
Email
ake.holmberg@regionstockholm.se
Facility Name
Karolinska Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabian Arnberg, MD, PhD
Email
fabian.arnberg@regionstockholm.se
First Name & Middle Initial & Last Name & Degree
Jiri Bartek, MD, PhD
Email
jiri.bartek@ki.se
First Name & Middle Initial & Last Name & Degree
Fabian Arnberg, MD, PhD
Facility Name
Norrlands Universitetssjukhus
City
Umeå
ZIP/Postal Code
90737
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Lindvall, MD, PhD
Email
Peter.Lindvall@regionvasterbotten.se
First Name & Middle Initial & Last Name & Degree
Alexander Henze, MD
Email
Alexander.Henze@regionvasterbotten.se
First Name & Middle Initial & Last Name & Degree
Peter Lindvall, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36348417
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.
Results Reference
derived
Learn more about this trial
Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma
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