Embolization of Middle Meningeal Artery in Chronic Subdural Hematoma

NCT04511572 | Recruiting DMC

• 1 other identifier: AMC Eliminate
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Subdural Hematomas

Outcome Measures

Primary Outcomes (3)

• Reoperation

  Number of patients who require a reoperation for recurrent cSDH

  8 weeks after discharge.

• Reoperation

  Number of patients who require a reoperation for recurrent cSDH

  16 weeks after discharge.

• Reoperation

  Number of patients who require a reoperation for recurrent cSDH

  24 weeks after discharge.

Secondary Outcomes (24)

• Hematoma volume reduction

  8 weeks after discharge.

• Hematoma volume reduction

  16 weeks after discharge.

• Hematoma volume reduction

  24 weeks after discharge.

• Complications

  8 weeks after discharge.

• Complications

  16 weeks after discharge.

Study Arms (2)

Standard Care: burr hole surgery

NO INTERVENTION

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.

embolisation middle meningeal artery

ACTIVE COMPARATOR

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

Interventions

embolization of the middle meningeal artery PROCEDURE

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.

embolisation middle meningeal artery

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• · CT-confirmed diagnosis of chronic Subdural Hematoma;
• Primary surgical treatment based on clinical symptoms (progressive neurological deficits).

You may not qualify if:

• · 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;

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam university medical Centers

Amsterdam, 1100 DD, Netherlands

RECRUITING

Related Publications (39)

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Related Links

• Efficacy of Atorvastatin in Chronic Subdural Haematoma (REACH).
• Tranexamic Acid to Prevent OpeRation in Chronic Subdural Hematoma
• Tocilizumab (RoActemra) and Tranexamic Acid (Cyklokapron) Used as Adjuncts to Chronic Subdural Hematoma Surgery.
• Tranexamic Acid in the Treatment of Residual Chronic Subdural Hematoma (TRACE).
• Treatment of Chronic Subdural Hematoma by Corticosteroids (SUCRE)
• Guideline for economic evaluations in healthcare
• Code of Conduct for Medical Research

MeSH Terms

Conditions

Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Hematoma, Subdural; 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; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Study Officials

• William P. Vandertop, MD PhD

  Amsterdam Universities Medical Centers

  STUDY CHAIR

Central Study Contacts

Dagmar Verbaan, PhD

CONTACT

+31205663316; d.verbaan@amsterdamumc.nl

R. van den Berg, MD PhD

CONTACT

+31205669111; r.vdberg@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chair Neurosurgery

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 13, 2020
• Study Start: December 10, 2020
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)