Subdural Hematoma, Non-acute Clinical Trial
— MAGIC-MTOfficial title:
Managing Non-acute Subdural Hematoma Using Liquid Materials：a Chinese Randomized Trial of MMA Treatment
| Verified date | August 2023 |
| Source | Huashan Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 722 |
| Est. completion date | June 17, 2024 |
| Est. primary completion date | August 17, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Huashan Hospital | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Huashan Hospital | Shanghai Municipal Health Commission, Shanghai Shen Kang Hospital Development Center |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of symptomatic SDH recurrence/ progression within 90 days post-procedure | 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 |
90 days | |
| Secondary | Effectiveness | Incidence of SDH recurrence/ progression at 1 year post-procedure | 1 year post-procedure | |
| Secondary | Effectiveness | Rate of successful embolization of the target vessels (MMA trunk and branches) with ONYX base on DSA imaging | day 0 | |
| Secondary | Effectiveness | Change in hematoma thickness based on CT/MRI imaging at 90 days post-procedure | 90 days post-procedure | |
| Secondary | Effectiveness | Changes in hematoma volume at 90 days post-procedure | 90 days post-procedure | |
| Secondary | Effectiveness | Change in Midline shift based on CT/MRI imaging at 90 days post-procedure | 90 days post-procedure | |
| Secondary | Effectiveness | Change in the Modified Rankin Scale score (mRS) Grade 0 (no symptoms) to 6 (death) at 90 days and 1 year post-procedure | 90 days and 1 year post-procedure | |
| Secondary | Effectiveness | Percentage of patients with favorable functional outcome defined as Modified Rankin Scale of 0 to 3 at 90 days and 1year post-procedure | 90 days and 1 year post-procedure | |
| Secondary | Effectiveness | Percentage of patients with good functional outcome defined as Modified Rankin Scale of 0 to 2 at 90 days and 1 year post-procedure | 90 days and 1 year post-procedure | |
| Secondary | Effectiveness | Quality of life assessed by (EuroQol) EQ-5D scale Grade 0 (worst health) to 100 (best health) at 90 days and 1 year post-procedure | 90 days and 1 year post-procedure | |
| Secondary | Safety endpoint | Total patients with SAEs within 90 days post-procedure | 90 days | |
| Secondary | Safety endpoint | Incidence of neurological death within 90 days post-procedure | 90 days | |
| Secondary | Safety endpoint | Incidence of procedural serious complications within 30 days post-procedure: symptomatic procedure-related intracranial hemorrhage any procedure-related intracranial hemorrhage any procedure-related neurological deficit CNS infection caused by procedure procedure-related artery dissection, vessel wall damage and vessel perforation procedure-related ischemic event retroperitoneal hematoma (femoral access)/wrist hematoma (radial access) neuropathy at the puncture site contrast agent allergy or encephalopathy |
30 days |