NCT04511572 Embolization of Middle Meningeal Artery in Chronic Subdural Hematoma
| NCT ID | NCT04511572 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Chronic Subdural Hematomas |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2020-12-10 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 170 participants in total. It began in 2020-12-10 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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;
Contact & Investigator
William P. Vandertop, MD PhD
STUDY CHAIR
Amsterdam Universities Medical Centers
Frequently Asked Questions
Who can join the NCT04511572 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 90 Years, studying Chronic Subdural Hematomas. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04511572 currently recruiting?
Yes, NCT04511572 is actively recruiting participants. Contact the research team at d.verbaan@amsterdamumc.nl for enrollment information.
Where is the NCT04511572 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT04511572 clinical trial?
NCT04511572 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is William P. Vandertop, MD PhD at Amsterdam Universities Medical Centers. The trial plans to enroll 170 participants.