An interventional study of embolization of the middle meningeal artery in Chronic Subdural Hematomas, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 1 site in Netherlands. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment
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.
Chronic subdural hematoma A chronic subdural hematoma (cSDH) is a bleeding of the bridging veins between the dura mater and the arachnoid.
Subdural hematomas are one of the most common forms of hemorrhage affecting mostly elderly people. The estimated incidence in Western countries is 8.1 per 100,000 per year in patients aged 65 years or older, but increases to 58/100,000/year for those aged 70 years or older. With the elderly population growing, the incidence of cSDH is expected to double by 2030. CSDH presents itself as an heterogeneous disease with various symptoms. Most common are gait disturbances, focal deficits, headaches and hemiparesis. Risk factors for occurrence are chronic alcoholism, male gender and anticoagulation and antiplatelet therapy. CSDH is a challenging disease of which the pathophysiology is not completely clear. Even though cSDH initially arises due to tearing of the bridging veins, its chronicity likely has an arterial origin. At first a subdural hematoma forms after a (minor) head trauma. The hematoma persists due to failure of the reparative and absorbing mechanisms. The current hypothesis states that the inability of the human body to heal the hematoma is due to increased neovascularization in the subdural membrane of the hematoma. This leads to repeated micro hemorrhages and further increase in fibrinolytic activity, which makes the body unable to stop recurrent microbleeds. Repeated micro hemorrhages are caused by collateral blood vessels originating from the middle meningeal artery. The correlation between the cycle of re-bleeding and fibrinolysis, and reabsorption of the subdural collection will determine whether the cSDH will resolve, persist or enlarge.
Treatment options The first treatment option for mildly symptomatic cSDH is a conservative 'wait-and-scan' approach in which the patient is followed with CT-scans and outpatient clinic visits. The majority (75%) of these conservatively managed patients however, eventually still require surgery (own data). Medical treatment is a second non-surgical treatment option currently being studied in large RCTs, for instance with steroids (dexamethasone), mannitol, tranexamic acid (TORCH-study), statins and ACE-inhibitors.
Surgical treatment is most frequently used in symptomatic patients with a cSDH as surgery provides instant decompression of the brain and rapid relief of (life-threatening) symptoms. However, surgery is costly and in these often frail patients with multi-morbidity, surgery comes with significant risks for future cognitive functioning and therefore loss of independence. Furthermore, recurrence rates after surgery range from 9-30%, resulting in frequent re-operations. Therefore, the optimal treatment for cSDH remains a 'burning clinical question' for which neurologists and neurosurgeons do not have evidence-based answers. Multiple studies have described successful treatment with embolization of the middle meningeal artery as an adjunct to surgical evacuation. The goal of embolization is to devascularize the subdural membranes to a sufficient extent such that the balance is shifted from the continued rebleeding and accumulation of blood products towards reabsorption of the subdural effusion. The use of embolization in cSDH patients was first reported in 2000, and since then multiple case reports, case series and cohort studies have been published investigating the safety and effectiveness. The largest cohort study compared 72 patients with embolization (as sole treatment or with surgical treatment combined) to 469 (retrospectively) non-surgical treated patients. In this study no complications were reported and only one patient needed repeat surgery. A relatively large case series of 60 patients was reported, again with no complications and a success rate of 92% (patients who were able to avoid surgery). Recent systematic reviews on middle meningeal artery embolization highlight the lower recurrence and complication rate in all embolization cases (\<5% and 0%, respectively). Nevertheless, these results are based on non-randomized studies with moderate quality and a small sample size. The effect of embolization as an adjunct to surgical evacuation has never been evaluated in a randomized controlled trial.
In conclusion, although surgery is still the primary treatment option for the majority of patients with cSDH, it carries a significant risk of additional morbidity and mortality and has a relatively high risk of treatment failure. In the aging population, comorbidities are more frequent and the risk of peri-operative complications is acknowledged, limiting a favorable clinical outcome. Middle meningeal artery embolization appears to be a promising adjunct therapy to surgery, which might reduce the necessity for repeat surgical treatment and improve clinical outcome is this vulnerable patient group.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 170 is close to the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 183 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
CT-confirmed diagnosis of chronic Subdural Hematoma;
Exclusion Criteria:
Significant to angiography (eg. allergy for contrast);
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Reoperation
Number of patients who require a reoperation for recurrent cSDH
Time frame: 8 weeks after discharge.
Reoperation
Number of patients who require a reoperation for recurrent cSDH
Time frame: 16 weeks after discharge.
Reoperation
Number of patients who require a reoperation for recurrent cSDH
Time frame: 24 weeks after discharge.
Hematoma volume reduction
hematoma volumes are measured on CT-scan of the head and compared to pre-operative volume
Time frame: 8 weeks after discharge.
Hematoma volume reduction
hematoma volumes are measured on CT-scan of the head and compared to pre-operative volume
Time frame: 16 weeks after discharge.
Hematoma volume reduction
hematoma volumes are measured on CT-scan of the head and compared to pre-operative volume
Time frame: 24 weeks after discharge.
Complications
Number of complications will be monitored
Time frame: 8 weeks after discharge.
Complications
Number of complications will be monitored
Time frame: 16 weeks after discharge.
Complications
Number of complications will be monitored
Time frame: 24 weeks after discharge.
modified National Institute Health Stroke Scale score
Neurological impairment measurement using mNIHSS; score 0 (no symptoms) to 31 (severe stroke)
Time frame: 8 weeks after discharge.
modified National Institute Health Stroke Scale score
Neurological impairment measurement using mNIHSS; score 0 (no symptoms) to 31 (severe stroke)
Time frame: 16 weeks after discharge.
modified Rankin Scale score
functional outcome measurement using mRS; score 0 (no symptoms) to 5 (severe handicap)
Time frame: 24 weeks after discharge.
modified National Institute Health Stroke Scale score
Neurological impairment measurement using mNIHSS; score 0 (no symptoms) to 31 (severe stroke)
Time frame: 24 weeks after discharge.
Montreal Cognitive Assessment
cognitive functioning measurement using MOCA; score 0 (severe deficit to 30 (no deficit)
Time frame: 8 weeks after discharge.
Montreal Cognitive Assessment
cognitive functioning measurement using MOCA; score 0 (severe deficit to 30 (no deficit)
Time frame: 16 weeks after discharge.
Montreal Cognitive Assessment
cognitive functioning measurement using MOCA; score 0 (severe deficit to 30 (no deficit)
Time frame: 24 weeks after discharge.
mortality
mortality rate
Time frame: 8 weeks after discharge.
mortality
mortality rate
Time frame: 16 weeks after discharge.
mortality
mortality rate
Time frame: 246 weeks after discharge.
Activities of Daily Living Scale
Assesses functional independence, generally in stroke patients; score 0 (totally dependent to 100 (completely independent)
Time frame: at 24 weeks after discharge.
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.
Time frame: at 24 weeks after discharge.
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.
Time frame: at 24 weeks after discharge.
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.
Time frame: at 24 weeks after discharge.
Productivity Cost Questionnaire
Care- and health-related costs measurement using a generic instrument for measuring medical costs
Time frame: at 24 weeks after discharge.
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)
Time frame: at eight weeks after discharge
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)
Time frame: at 16 weeks after discharge
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)
Time frame: at 24 weeks after discharge
Plan to share: No
Started Dec 2020 (actual). Primary completion is estimated for Jul 2025, 54 months after the start.
Of 44 interventional studies with no phase under Hematoma, Subdural, Chronic, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 70. This study's planned 54 months is above that.
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