Managing Non-acute Subdural Hematoma Using Liquid Materials：a Chinese Randomized Trial of MMA Tre… (NCT04700345) | Clinical Trial Compass
UnknownNot Applicable
Managing Non-acute Subdural Hematoma Using Liquid Materials：a Chinese Randomized Trial of MMA Treatment
China722 participantsStarted 2021-03-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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);
What they're measuring
1
Incidence of symptomatic SDH recurrence/ progression within 90 days post-procedure