Improving the Outcome of Chronic Subdural Hematoma by Embolization of Middle Meningeal Artery (ELIMINATE)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 90
Healthy Volunteers: f
View:

• · CT-confirmed diagnosis of chronic Subdural Hematoma;

⁃ Primary surgical treatment based on clinical symptoms (progressive neurological deficits).

Locations
Other Locations
Netherlands
Amsterdam university medical Centers
RECRUITING
Amsterdam
Contact Information
Primary
Dagmar Verbaan, PhD
d.verbaan@amsterdamumc.nl
+31205663316
Backup
R. van den Berg, MD PhD
r.vdberg@amsterdamumc.nl
+31205669111
Time Frame
Start Date: 2020-12-10
Estimated Completion Date: 2025-10-01
Participants
Target number of participants: 170
Treatments
No_intervention: Standard Care: burr hole surgery
Patients who have had burr hole evacuation for symptomatic chronic subdural hematomas will be followed in the outpatient clinic after hospital discharge at 8, 16 and 24 weeks with a follow-up CT-scan of the head in addition to assessment of mRS, MOCA, mNIHSS, Markwalder score, SF-36, EQ-5D-5L, ALDS, iMCQ and iPCQ.
Active_comparator: embolisation middle meningeal artery
Besides standard treatment those patient who are allotted to the intervention group will receive embolization of the middle meningeal artery until 72 hours after burr hole evacuation. After hospital discharge follow-up is at 8, 16 and 24 weeks with a follow-up CT-scan of the head in addition to assessment of mRS, MOCA, mNIHSS, Markwalder score, SF-36, EQ-5D-5L, ALDS, iMCQ and iPCQ.
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov