Clinical trial NCT04700345: Managing Non-acute Subdural Hematoma Using Liquid Materials：a Chinese Randomized Trial of MMA Treatment
Official title: Managing Non-acute Subdural Hematoma Using Liquid Materials：a Chinese Randomized Trial of MMA Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Subdural Hematoma, Non-acute
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Municipal Health Commission
name: Shanghai Shen Kang Hospital Development Center
First posted: 2021-01-07
Enrollment: 722
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of symptomatic SDH recurrence/ progression within 90 days post-procedure
timeFrame: 90 days
Secondary outcomes:
measure: Effectiveness
timeFrame: 1 year post-procedure
measure: Effectiveness
timeFrame: day 0
measure: Effectiveness
timeFrame: 90 days post-procedure
measure: Effectiveness
timeFrame: 90 days post-procedure
measure: Effectiveness
timeFrame: 90 days post-procedure
measure: Effectiveness
timeFrame: 90 days and 1 year post-procedure
measure: Effectiveness
timeFrame: 90 days and 1 year post-procedure
measure: Effectiveness
timeFrame: 90 days and 1 year post-procedure
measure: Effectiveness
timeFrame: 90 days and 1 year post-procedure
measure: Safety endpoint
timeFrame: 90 days
measure: Safety endpoint
timeFrame: 90 days
measure: Safety endpoint
timeFrame: 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
affiliation: department of Neurosurgery, Huashan Hospital,Fudan University
name: Ying Mao, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurovascular Center, Trauma Center, Changhai Hospital, Naval Medical University
name: Jian Min Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: