Status:
UNKNOWN
Managing Non-acute Subdural Hematoma Using Liquid Materials：a Chinese Randomized Trial of MMA Treatment
Lead Sponsor:
Huashan Hospital
Collaborating Sponsors:
Shanghai Municipal Health Commission
Shanghai Shen Kang Hospital Development Center
Conditions:
Subdural Hematoma, Non-acute
Eligibility:
All Genders
18+ years
Phase:
NA
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)...
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 tre...
Eligibility Criteria
Inclusion
- Patients with symptomatic non-acute SDH with mass effect (i.e., chronic or subacute SDH)
- Mass effect refers to a shift in midline structure or deformation of local cerebral cortex due to SDH.
- 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.
- Age ≥18 years;
- Pre-morbid mRS score 2;
- Informed Consent Form (ICF) signed by patient or guardian.
Exclusion
- Radiographic imaging indicating massive cerebral infarction with corresponding symptoms;
- Required craniotomy or craniotomy with small bone flap to remove SDH;
- Emergency SDH removal/drainage;
- Bilateral SDH with unknown origin of symptoms;
- Anatomical variations that may affect the safety of MMA embolization (e.g., prominent middle MMA-ophthalmic artery anastomosis);
- Intractable coagulation dysfunction or abnormal platelet count and function (pre-operative International Normalized Ratio \[INR\] \> 1.5 and/or platelet count \< 80109/L);
- Contraindications to cerebral angiography, such as allergy to iodinated contrast agents, renal insufficiency (GFR \< 30 ml/min), etc.;
- Computed tomography (CT) or magnetic resonance imaging (MRI) showing intracranial space-occupying lesions;
- Pregnancy or planning to become pregnant;
- Serious or fatal coexisting disease that may prevent improvement of conditions or completion of follow-up;
- Life expectancy \< 1 year;
- Recent operation unrelated to this study or investigators believe that they will be at higher risks if antiplatelet and/or anticoagulant drugs are discontinued;
- Inability to complete follow-up as required by the protocol;
- Patients participating in other clinical trials;
- Prior surgery or interventional therapy on target SDH;
- Inability to complete MMA embolization before trepanation and drainage.
Key Trial Info
Start Date :
March 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 17 2024
Estimated Enrollment :
722 Patients enrolled
Trial Details
Trial ID
NCT04700345
Start Date
March 21 2021
End Date
June 17 2024
Last Update
April 30 2024
Active Locations (1)
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1
Huashan Hospital
Shanghai, Shanghai Municipality, China