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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04511572
Other study ID # AMC Eliminate
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 10, 2020
Est. completion date October 1, 2025

Study information

Verified date July 2023
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Dagmar Verbaan, PhD
Phone +31205663316
Email d.verbaan@amsterdamumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Intervention

Procedure:
embolization of the middle meningeal artery
The embolization procedure will be as follows: first femoral artery access will be obtained by using a 5 French micropuncture kit and common carotid and external carotid angiography is performed using a standard 5 French diagnostic catheter. A microcatheter is then advanced selectively under roadmap guidance into the middle meningeal artery (MMA), and MMA angiography is performed to evaluate for potential dangerous anastomoses such as the orbital branch to the ophthalmic artery. Embolization is performed using polyvinyl alcohol particles (100 microns in diameter) under blank fluoroscopic roadmap while carefully avoiding reflux. Particles are infused until lack of anterograde flow into the MMA branches is demonstrated on angiography, and the catheters are removed [31]. The procedure is performed under local anesthesia.

Locations

Country Name City State
Netherlands Amsterdam university medical Centers Amsterdam

Sponsors (1)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

References & Publications (39)

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Outcome

Type Measure Description Time frame Safety issue
Primary Reoperation Number of patients who require a reoperation for recurrent cSDH 8 weeks after discharge.
Primary Reoperation Number of patients who require a reoperation for recurrent cSDH 16 weeks after discharge.
Primary Reoperation Number of patients who require a reoperation for recurrent cSDH 24 weeks after discharge.
Secondary Hematoma volume reduction hematoma volumes are measured on CT-scan of the head and compared to pre-operative volume 8 weeks after discharge.
Secondary Hematoma volume reduction hematoma volumes are measured on CT-scan of the head and compared to pre-operative volume 16 weeks after discharge.
Secondary Hematoma volume reduction hematoma volumes are measured on CT-scan of the head and compared to pre-operative volume 24 weeks after discharge.
Secondary Complications Number of complications will be monitored 8 weeks after discharge.
Secondary Complications Number of complications will be monitored 16 weeks after discharge.
Secondary Complications Number of complications will be monitored 24 weeks after discharge.
Secondary modified National Institute Health Stroke Scale score Neurological impairment measurement using mNIHSS; score 0 (no symptoms) to 31 (severe stroke) 8 weeks after discharge.
Secondary modified National Institute Health Stroke Scale score Neurological impairment measurement using mNIHSS; score 0 (no symptoms) to 31 (severe stroke) 16 weeks after discharge.
Secondary modified Rankin Scale score functional outcome measurement using mRS; score 0 (no symptoms) to 5 (severe handicap) 24 weeks after discharge.
Secondary modified National Institute Health Stroke Scale score Neurological impairment measurement using mNIHSS; score 0 (no symptoms) to 31 (severe stroke) 24 weeks after discharge.
Secondary Montreal Cognitive Assessment cognitive functioning measurement using MOCA; score 0 (severe deficit to 30 (no deficit) 8 weeks after discharge.
Secondary Montreal Cognitive Assessment cognitive functioning measurement using MOCA; score 0 (severe deficit to 30 (no deficit) 16 weeks after discharge.
Secondary Montreal Cognitive Assessment cognitive functioning measurement using MOCA; score 0 (severe deficit to 30 (no deficit) 24 weeks after discharge.
Secondary mortality mortality rate 8 weeks after discharge.
Secondary mortality mortality rate 16 weeks after discharge.
Secondary mortality mortality rate 246 weeks after discharge.
Secondary Activities of Daily Living Scale Assesses functional independence, generally in stroke patients; score 0 (totally dependent to 100 (completely independent) at 24 weeks after discharge.
Secondary Short Form Health Survey Quality of life measurement using a 36-item, patient-reported survey of patient health; consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. at 24 weeks after discharge.
Secondary EuroQol (EQ-5D-5L) questionnaire Quality of life measurement:The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. at 24 weeks after discharge.
Secondary Medical Consumption questionnaire Care- and health-related costs measurement using a generic instrument for measuring medical costs. The iMCQ includes questions related to frequently occurring contacts with health care providers and can be complemented with extra questions that are relevant for specific study populations. at 24 weeks after discharge.
Secondary Productivity Cost Questionnaire Care- and health-related costs measurement using a generic instrument for measuring medical costs at 24 weeks after discharge.
Secondary Markwalder grading scale score Neurological impairment measurement using the Markwalder grading scale; score 0 (neurologically normal) to 4 (Comatose with absent motor responses to painful stimuli, decerebrate or decorticate posturing) at eight weeks after discharge
Secondary Markwalder grading scale score Neurological impairment measurement using the Markwalder grading scale; score 0 (neurologically normal) to 4 (Comatose with absent motor responses to painful stimuli, decerebrate or decorticate posturing) at 16 weeks after discharge
Secondary Markwalder grading scale score Neurological impairment measurement using the Markwalder grading scale; score 0 (neurologically normal) to 4 (Comatose with absent motor responses to painful stimuli, decerebrate or decorticate posturing) at 24 weeks after discharge
See also
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Completed NCT02650609 - Treatment of Chronic Subdural Hematoma by Corticosteroids Phase 3
Not yet recruiting NCT06163547 - Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM) N/A