Subdural Hematoma, Non-acute
Conditions
Brief summary
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
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.
Interventions
DEVICEOnyx
Embolization of the Middle Meningeal Artery using the liquid embolic material
PROCEDUREBurr-hole
Burr-hole drainage of subdural hematoma
OTHERMedical Management
best medical management
Sponsors
Shanghai Municipal Health Commission
Shanghai Shen Kang Hospital Development Center
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with symptomatic non-acute SDH with mass effect (i.e., chronic or subacute SDH) 1. Mass effect refers to a shift in midline structure or deformation of local cerebral cortex due to SDH. 2. Symptomatic defined as neurological symptoms, such as headache, short-term cognitive dysfunction, language disorder or aphasia, gait instability, decreased muscle strength, sensory disturbances, epileptic seizure, etc. 2. Age ≥18 years; 3. Pre-morbid mRS score 2; 4. Informed Consent Form (ICF) signed by patient or guardian.
Exclusion criteria
1. Radiographic imaging indicating massive cerebral infarction with corresponding symptoms; 2. Required craniotomy or craniotomy with small bone flap to remove SDH; 3. Emergency SDH removal/drainage; 4. Bilateral SDH with unknown origin of symptoms; 5. Anatomical variations that may affect the safety of MMA embolization (e.g., prominent middle MMA-ophthalmic artery anastomosis); 6. Intractable coagulation dysfunction or abnormal platelet count and function (pre-operative International Normalized Ratio \[INR\] \> 1.5 and/or platelet count \< 80109/L); 7. Contraindications to cerebral angiography, such as allergy to iodinated contrast agents, renal insufficiency (GFR \< 30 ml/min), etc.; 8. Computed tomography (CT) or magnetic resonance imaging (MRI) showing intracranial space-occupying lesions; 9. Pregnancy or planning to become pregnant; 10. Serious or fatal coexisting disease that may prevent improvement of conditions or completion of follow-up; 11. Life expectancy \< 1 year; 12. Recent operation unrelated to this study or investigators believe that they will be at higher risks if antiplatelet and/or anticoagulant drugs are discontinued; 13. Inability to complete follow-up as required by the protocol; 14. Patients participating in other clinical trials; 15. Prior surgery or interventional therapy on target SDH; 16. Inability to complete MMA embolization before trepanation and drainage.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of symptomatic SDH recurrence/ progression within 90 days post-procedure | 90 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness | 1 year post-procedure | Incidence of SDH recurrence/ progression at 1 year post-procedure |
| Safety endpoint | 90 days | Total patients with SAEs within 90 days post-procedure |
Countries
China
Outcome results
None listed