Preventing Recurrences of Chronic Subdural Hematoma in Adult Patients by Middle Meningeal Artery Embolization

Study Overview
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Brief Summary
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Patients with a chronic subdural hematoma (cSDH), that is, a blood accumulation between two meninges developing over a long period of time, often have recurrent bleedings after an initial operation. The study aims to show that additional surgery reduces the risk of recurrent bleeding. The additional procedure aims to block small blood vessels in the skull with tiny plastic particles. The small blood vessels are embolized using X-rays and a contrast medium and a fine tube that is inserted into the diseased vessels of the head via the groin. Patients of full age who have undergone burr hole trepanation as a first operation, i.e. a blood drain through a hole in the cranial cavity, can participate in the study. Participating patients are randomly assigned to a control group with treatment according to clinical routine or a treatment group with an additional occlusion of the blood vessels in the skull. In addition, patients can consent to a genetic test to determine the relationship between a coagulation factor and the risk of recurrence of the hematoma. In order to record the test results, check-up examinations are carried out after one and three months.

Official Title
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Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE)

Conditions
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Hematoma, Subdural, Chronic

Intervention / Treatment
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* Procedure: Surgery plus endovascular MMA embolization
* Procedure: Surgery alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have undergone surgery by means of one or more burr hole trepanations during the first manifestation of a cSDH (unihemispherical or bihemispherical) detected by computed tomography or magnetic resonance tomography Age ≥18 years Sufficient compliance and ability to consent Patient's informed consent for surgical as well as endovascular interventional procedure and participation in the study Exclusion Criteria: Conservatively treated cSDH Radiological evidence of an acute or subacute subdural hematoma, subarachnoid hemorrhage, intracerebral hematoma or epidural hematoma Surgical technique: craniotomy, craniectomy, bilateral burr hole trepanation Angiography cannot be performed within 72 hours after surgery Age <18 years Supervisory relationship Pregnancy Lack of informed consent Lack of compliance Homozygous factor XIII deficiency with residual activity <10%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgery plus endovascular MMA embolization<br> | Procedure: Surgery plus endovascular MMA embolization<br>* A micro catheter is inserted transfemorally into the branches of the middle meningeal artery (MMA) in a minimally invasive manner and the periphery is occluded using polyvinyl alcohol (PVA) particles to prevent future bleeding. If the desired catheter position cannot be achieved due to the anatomical conditions, a more proximal closure of the MMA using Onyx® or micro-electric coils is performed. Embolization of the MMA by PVA particles with sizes between 40-300 µm is preferred over embolization by coils and Onyx®, since the capillary network of the dura is entirely blocked when using particles. In order to identify the vessels to be closed, a digital subtraction angiography (DSA) is performed.<br>|
| Active Comparator: Surgery alone<br> | Procedure: Surgery alone<br>* Evacuation of cSDH<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cSDH recurrence rates after surgery | A recurrence occurs when at least one of the following criteria is met: recurrent cSDH with at least the same volume (>- 10%) compared to the findings at baseline and / or recurrent cSDH which requires surgery | Within three months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impairment due to neurological deficits assessed by the modified Rankin Scale | Modified Rankin scale ranges from 0 (no symptoms) to 5 (severe disability) | Evaluated at three months after baseline | 
| Number of recurrence-associated complications | Examined on a binary scale | Within three months of follow-up | 
| Number of complications associated with interventional therapy | Examined on a binary scale | Within three months of follow-up |