Managing Non-acute Subdural Hematoma Using Liquid Materials：a Chinese Randomized Trial of MMA Treatment

Study Overview
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Brief Summary
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MAGIC-MT study is multi-center, prospective, randomized (1:1) controlled trial designed to show that additional MMA embolization with Onyx in patients with non-acute symptomatic subdural hematoma(SDH) results in reduced hematoma recurrence in surgically treated patients/ reduced hematoma progression in conservatively managed patients.

Detailed Description
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The objective of this study is to show that additional MMA embolization with Onyx in patients with non-acute symptomatic subdural hematoma(SDH) results in reduced hematoma recurrence in surgically treated patients/ reduced hematoma progression in conservatively managed patients.

Official Title
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Managing Non-acute Subdural Hematoma Using Liquid Materials：a Chinese Randomized Trial of MMA Treatment

Conditions
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Subdural Hematoma, Non-acute

Intervention / Treatment
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* Device: Onyx
* Procedure: Burr-hole
* Other: Medical Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic non-acute SDH with mass effect (i.e. chronic or subacute SDH, fulfilling one or more of the following criteria) <30% hyperdense components septations that are indicative of a chronic SDH known from previous (>2 weeks old) brain imaging Mass effect is defined as midline shift or deformation of the normal contour of the brain (i.e. flattening) due to the SDH. Symptomatic SDH is defined as an SDH that fulfills one or more of the following criteria AND shows neurological symptoms (headache, short-term cognitive decline, speech difficulty or aphasia, gait impairment, focal weakness, sensory deficits, seizures) that are attributable to the hematoma Age 18 or higher Independent functional status in activities of daily living with mRS score ≤ 2 prior to the symptom. Signed informed consent or appropriate signed deferral of consent where approved. Exclusion Criteria: Qualifying imaging reveals clear hypodense demarcation of the majority of the territory of symptomatic intracranial occlusion. Subject requires (in the opinion of the treating surgeon) a full or mini craniotomy. Subject with urgent or emergent subdural hematoma evacuation needed. Bilateral SDH with unknown origin of symptoms. Any evidence of anatomical variants that might render safe MMA embolization impossible (e.g. prominent MMA-ophtalmic artery anastomoses) Coagulation and platelet disorders, or antiplatelet medication that is not easily correctable with INR >1.5 and/or platelet count < 80.000. Contraindications for neurangiography, e.g. iodinated contrast allergy, renal insufficiency with GFR < 30 ml/min. CT or MRI evidence of intra-cranial tumor or mass lesion. Pregnancy; if a woman is of child-bearing potential a urine or serum beta HCG test is positive. Patient has a severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient. Life expectancy <1 year. High risk of removal from antiplatelet and/or anticoagulant medical therapy for recent procedure or other reasons. Patient cannot complete follow-up for any reason. (eg. visiting from another city, illness, incarceration in prison etc.) Participation in another clinical trial investigating a drug, medical device, or a medical procedure that might confound treatment and outcomes related to the current trial. Previous surgery or endovascular treatment for the SDH under investigation Unable to undergo MMA embolization prior to surgical treatment.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embolization<br>Middle meningeal artery(MMA) embolization | Device: Onyx<br>* Embolization of the Middle Meningeal Artery using the liquid embolic material<br>Procedure: Burr-hole<br>* Burr-hole drainage of subdural hematoma<br>Other: Medical Management<br>* best medical management<br>|
| Active Comparator: No embolization<br>Traditional treatment group | Procedure: Burr-hole<br>* Burr-hole drainage of subdural hematoma<br>Other: Medical Management<br>* best medical management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic SDH recurrence/ progression within 90 days post-procedure | SDH recurrence (>10 mm max. thickness) or receiving re-operation in patients who underwent surgery/ symptomatic SDH progression (>3 mm increase in max thickness or receiving surgical rescue in patients who did not undergo sugery) at 90 days Symptomatic is hereby defined as one or more of the following features which are attributed to the progression/recurrence: headache, short-term cognitive decline, speech difficulty or aphasia, gait impairment, focal weakness, sensory deficits, seizures | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | Incidence of SDH recurrence/ progression at 1 year post-procedure | 1 year post-procedure | 
| Effectiveness | Rate of successful embolization of the target vessels (MMA trunk and branches) with ONYX base on DSA imaging | day 0 | 
| Effectiveness | Change in hematoma thickness based on CT/MRI imaging at 90 days post-procedure | 90 days post-procedure | 
| Effectiveness | Changes in hematoma volume at 90 days post-procedure | 90 days post-procedure | 
| Effectiveness | Change in Midline shift based on CT/MRI imaging at 90 days post-procedure | 90 days post-procedure | 
| Effectiveness | Change in the Modified Rankin Scale score (mRS) Grade 0 (no symptoms) to 6 (death) at 90 days and 1 year post-procedure | 90 days and 1 year post-procedure | 
| Effectiveness | Percentage of patients with favorable functional outcome defined as Modified Rankin Scale of 0 to 3 at 90 days and 1year post-procedure | 90 days and 1 year post-procedure | 
| Effectiveness | Percentage of patients with good functional outcome defined as Modified Rankin Scale of 0 to 2 at 90 days and 1 year post-procedure | 90 days and 1 year post-procedure | 
| Effectiveness | Quality of life assessed by (EuroQol) EQ-5D scale Grade 0 (worst health) to 100 (best health) at 90 days and 1 year post-procedure | 90 days and 1 year post-procedure | 
| Safety endpoint | Total patients with SAEs within 90 days post-procedure | 90 days | 
| Safety endpoint | Incidence of neurological death within 90 days post-procedure | 90 days | 
| Safety endpoint | Incidence of procedural serious complications within 30 days post-procedure: symptomatic procedure-related intracranial hemorrhage any procedure-related intracranial hemorrhage any procedure-related neurological deficit CNS infection caused by procedure procedure-related artery dissection, vessel wall damage and vessel perforation procedure-related ischemic event retroperitoneal hematoma (femoral access)/wrist hematoma (radial access) neuropathy at the puncture site contrast agent allergy or encephalopathy | 30 days |