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Embolization of Middle Meningeal Artery in Chronic Subdural Hematoma (ELIMINATE)

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ClinicalTrials.gov Identifier: NCT04511572
Recruitment Status : Recruiting
First Posted : August 13, 2020
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
Prof. dr. W.Peter Vandertop, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Subdural Hematomas Procedure: embolization of the middle meningeal artery Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving the Outcome of Chronic Subdural Hematoma by Embolization of Middle Meningeal Artery (ELIMINATE)
Actual Study Start Date : December 10, 2020
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : January 1, 2024
Arms and Interventions
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Arm Intervention/treatment
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Reoperation [ Time Frame: 8 weeks after discharge. ]
    Number of patients who require a reoperation for recurrent cSDH

  2. Reoperation [ Time Frame: 16 weeks after discharge. ]
    Number of patients who require a reoperation for recurrent cSDH

  3. Reoperation [ Time Frame: 24 weeks after discharge. ]
    Number of patients who require a reoperation for recurrent cSDH


Secondary Outcome Measures :
  1. Hematoma volume reduction [ Time Frame: 8 weeks after discharge. ]
    hematoma volumes are measured on CT-scan of the head and compared to pre-operative volume

  2. Hematoma volume reduction [ Time Frame: 16 weeks after discharge. ]
    hematoma volumes are measured on CT-scan of the head and compared to pre-operative volume

  3. Hematoma volume reduction [ Time Frame: 24 weeks after discharge. ]
    hematoma volumes are measured on CT-scan of the head and compared to pre-operative volume

  4. Complications [ Time Frame: 8 weeks after discharge. ]
    Number of complications will be monitored

  5. Complications [ Time Frame: 16 weeks after discharge. ]
    Number of complications will be monitored

  6. Complications [ Time Frame: 24 weeks after discharge. ]
    Number of complications will be monitored

  7. modified National Institute Health Stroke Scale score [ Time Frame: 8 weeks after discharge. ]
    Neurological impairment measurement using mNIHSS; score 0 (no symptoms) to 31 (severe stroke)

  8. modified National Institute Health Stroke Scale score [ Time Frame: 16 weeks after discharge. ]
    Neurological impairment measurement using mNIHSS; score 0 (no symptoms) to 31 (severe stroke)

  9. modified Rankin Scale score [ Time Frame: 24 weeks after discharge. ]
    functional outcome measurement using mRS; score 0 (no symptoms) to 5 (severe handicap)

  10. modified National Institute Health Stroke Scale score [ Time Frame: 24 weeks after discharge. ]
    Neurological impairment measurement using mNIHSS; score 0 (no symptoms) to 31 (severe stroke)

  11. Montreal Cognitive Assessment [ Time Frame: 8 weeks after discharge. ]
    cognitive functioning measurement using MOCA; score 0 (severe deficit to 30 (no deficit)

  12. Montreal Cognitive Assessment [ Time Frame: 16 weeks after discharge. ]
    cognitive functioning measurement using MOCA; score 0 (severe deficit to 30 (no deficit)

  13. Montreal Cognitive Assessment [ Time Frame: 24 weeks after discharge. ]
    cognitive functioning measurement using MOCA; score 0 (severe deficit to 30 (no deficit)

  14. mortality [ Time Frame: 8 weeks after discharge. ]
    mortality rate

  15. mortality [ Time Frame: 16 weeks after discharge. ]
    mortality rate

  16. mortality [ Time Frame: 246 weeks after discharge. ]
    mortality rate

  17. Activities of Daily Living Scale [ Time Frame: at 24 weeks after discharge. ]
    Assesses functional independence, generally in stroke patients; score 0 (totally dependent to 100 (completely independent)

  18. Short Form Health Survey [ Time Frame: at 24 weeks after discharge. ]
    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.

  19. EuroQol (EQ-5D-5L) questionnaire [ Time Frame: at 24 weeks after discharge. ]
    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.

  20. Medical Consumption questionnaire [ Time Frame: at 24 weeks after discharge. ]
    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.

  21. Productivity Cost Questionnaire [ Time Frame: at 24 weeks after discharge. ]
    Care- and health-related costs measurement using a generic instrument for measuring medical costs

  22. Markwalder grading scale score [ Time Frame: at eight weeks after discharge ]
    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)

  23. Markwalder grading scale score [ Time Frame: at 16 weeks after discharge ]
    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)

  24. Markwalder grading scale score [ Time Frame: at 24 weeks after discharge ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • · CT-confirmed diagnosis of chronic Subdural Hematoma;

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

Exclusion Criteria:

  • · Significant contraindication to angiography (eg. allergy for contrast);

    • Structural causes for subdural hemorrhage, e.g. arachnoid cysts, cortical vascular malformations and a history of cranial surgery in the previous 365 days;
    • Inability to obtain informed consent from the patient or legal representative (when the patient has a depressed level of consciousness), including language barrier;
    • Monocular blindness on contralateral side of the hematoma;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04511572


Contacts
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Contact: Dagmar Verbaan, PhD +31205663316 d.verbaan@amsterdamumc.nl
Contact: R. van den Berg, MD PhD +31205669111 ext 63316 r.vdberg@amsterdamumc.nl

Locations
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Netherlands
Amsterdam university medical Centers Recruiting
Amsterdam, Netherlands, 1100 DD
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Study Chair: William P. Vandertop, MD PhD Amsterdam Universities Medical Centers
More Information
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Additional Information:

Publications:

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Responsible Party: Prof. dr. W.Peter Vandertop, chair Neurosurgery, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT04511572    
Other Study ID Numbers: AMC Eliminate
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma, Subdural, Chronic
Hematoma
Hemorrhage
Pathologic Processes
Intracranial Hemorrhage, Traumatic
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Wounds and Injuries