Actively Recruiting
Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma
Led by Region Skane · Updated on 2024-04-09
288
Participants Needed
4
Research Sites
257 weeks
Total Duration
On this page
Sponsors
R
Region Skane
Lead Sponsor
L
Lund University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Swedish Trial on Embolization of Middle Meningeal Artery Versus Surgical Evacuation in Chronic Subdural Hematoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 to 89 years old
- Diagnosed with previously untreated unilateral or bilateral chronic subdural hematoma confirmed by CT or MRI
- Clinical and/or radiological indication for neurosurgical treatment
- Markwalder Scale score less than 2
- Glasgow Coma Scale score greater than 13
- Able to provide signed informed consent
You will not qualify if you...
- Acute subdural hematoma
- Focal, non-hemispheric chronic subdural hematoma
- Midline brain shift greater than 10 mm or signs of severe brain compression or herniation
- Structural causes for hematoma such as dural AV-fistula, AV malformation, tumor, arachnoid cyst, or ventriculoperitoneal shunt
- Contraindications to angiography
- Dependency with modified Rankin Scale score above 3
- Life expectancy less than 6 months
- Serious comorbidities preventing follow-up
- Participation in another interventional clinical study
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Sahlgenska University Hospital
Gothenburg, Sweden, 41345
Not Yet Recruiting
2
Skåne University Hospital
Lund, Sweden, 22185
Actively Recruiting
3
Karolinska Hospital
Stockholm, Sweden, 17176
Not Yet Recruiting
4
Norrlands Universitetssjukhus
Umeå, Sweden, 90737
Actively Recruiting
Research Team
Å
Åke Holmberg
CONTACT
J
Johan Wassélius, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here