Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Sweden
Sahlgenska University Hospital
NOT_YET_RECRUITING
Gothenburg
Skåne University Hospital
RECRUITING
Lund
Karolinska Hospital
NOT_YET_RECRUITING
Stockholm
Norrlands Universitetssjukhus
RECRUITING
Umeå
Contact Information
Primary
Åke Holmberg
ake.holmberg@regionstockholm.se
+46739660740
Backup
Johan Wassélius, MD, PhD
johan.wasselius@gmail.com
Time Frame
Start Date: 2022-03-28
Estimated Completion Date: 2027-03
Participants
Target number of participants: 288
Treatments
Experimental: Embolization of middle meningeal artery
Participants receive endovascular treatment with embolization of the middle meningeal artery ipsilaterally to the chronic subdural hematoma(s).
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.
Related Therapeutic Areas
Sponsors
Collaborators: Norrlands University Hospital, Karolinska University Hospital, Lund University, Sahlgrenska University Hospital
Leads: Region Skane