Actively Recruiting
Embolization of Middle Meningeal Artery in Chronic Subdural Hematoma
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2024-07-31
170
Participants Needed
1
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic subdural hematoma (cSDH) is a common neurological affliction which affects mostly frail and elderly patients. Surgical evacuation by using burr hole craniostomy (BHC) is the most frequently used treatment but carries a recurrence rate varying between 10-30% in the literature. Especially in this frail population re-operation is undesirable. Embolization of the middle meningeal artery is an adjuvant treatment which has been reported in multiple case reports and larger case series, showing a beneficial effect on recurrence rate, reducing it to \<5%, without complications. Objectives: Primary: To evaluate whether additional embolization of the middle meningeal artery after surgery for cSDH reduces the recurrent surgery rate. Secondary: to evaluate whether the use of middle meningeal artery embolization after surgical treatment in symptomatic cSDH patients increases quality of life (SF-36 and the EQ-5D-5L), performance in activities of daily living (AMC Linear Disability Score), functional outcome (mRS), cognitive functioning (MOCA) and reduces mortality, occurrence of complications, recurrence rate, size and volume of the hematoma, neurological impairment (mNIHSS, Markwalder score) and the use of care and health-related costs (iMCQ and iPCQ). Study design: Multicenter, randomized controlled open-label superiority trial. Study population: Patients diagnosed with a cSDH who require surgery. Intervention: The intervention group will receive embolization in addition to standard surgical treatment. The control group will receive surgery only. Main study endpoint: The number of patients who require reoperation within 24 weeks after the intervention. Symptomatic cSDH patients will undergo peri-operative embolization of the middle meningeal artery until 72 hours after surgical treatment. Complications are monitored during hospital admission and follow-up. Radiological and clinical follow-up is at eight, 16 and 24 weeks post-intervention with a CT-scan of the head and assessment of mRS, MOCA, mNIHSS, Markwalder score, SF-36, EQ-5D-5L, ALDS, iMCQ and iPCQ. Standard care after surgery entails outpatient follow-up with on average two CT-scans, indicated by clinical signs and symptoms.
CONDITIONS
Official Title
Embolization of Middle Meningeal Artery in Chronic Subdural Hematoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- CT-confirmed diagnosis of chronic subdural hematoma
- Primary surgical treatment planned due to progressive neurological symptoms
You will not qualify if you...
- Significant contraindication to angiography, such as allergy to contrast dye
- Structural causes for subdural hemorrhage like arachnoid cysts or cortical vascular malformations
- History of cranial surgery within the past 365 days
- Inability to give informed consent or language barrier
- Blindness in one eye on the side opposite the hematoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Amsterdam university medical Centers
Amsterdam, Netherlands, 1100 DD
Actively Recruiting
Research Team
D
Dagmar Verbaan, PhD
CONTACT
R
R. van den Berg, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
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