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

This is an interventional treatment trial for Subdural Hematoma, Non-acute Read More

Inclusion Criteria:

1. Symptomatic non-acute SDH with mass effect (i.e. chronic or subacute SDH, fulfilling one or more of the following criteria)

   1. <30% hyperdense components
   2. septations that are indicative of a chronic SDH
   3. 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

2. Age 18 or higher
3. Independent functional status in activities of daily living with mRS score ≤ 2 prior to the symptom.
4. Signed informed consent or appropriate signed deferral of consent where approved.

Exclusion Criteria:

1. Qualifying imaging reveals clear hypodense demarcation of the majority of the territory of symptomatic intracranial occlusion.
2. Subject requires (in the opinion of the treating surgeon) a full or mini craniotomy.
3. Subject with urgent or emergent subdural hematoma evacuation needed.
4. Bilateral SDH with unknown origin of symptoms.
5. Any evidence of anatomical variants that might render safe MMA embolization impossible (e.g. prominent MMA-ophtalmic artery anastomoses)
6. Coagulation and platelet disorders, or antiplatelet medication that is not easily correctable with INR >1.5 and/or platelet count < 80.000.
7. Contraindications for neurangiography, e.g. iodinated contrast allergy, renal insufficiency with GFR < 30 ml/min.
8. CT or MRI evidence of intra-cranial tumor or mass lesion.
9. Pregnancy; if a woman is of child-bearing potential a urine or serum beta HCG test is positive.
10. 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.
11. Life expectancy <1 year.
12. High risk of removal from antiplatelet and/or anticoagulant medical therapy for recent procedure or other reasons.
13. Patient cannot complete follow-up for any reason. (eg. visiting from another city, illness, incarceration in prison etc.)
14. 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.
15. Previous surgery or endovascular treatment for the SDH under investigation
16. Unable to undergo MMA embolization prior to surgical treatment.