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| Name | Class |
|---|---|
| Shanghai Municipal Health Commission | UNKNOWN |
| Shanghai Shen Kang Hospital Development Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embolization | Experimental | Middle meningeal artery(MMA) embolization |
|
| No embolization | Active Comparator | Traditional treatment group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Onyx | Device | Embolization of the Middle Meningeal Artery using the liquid embolic material |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness | Incidence of SDH recurrence/ progression at 1 year post-procedure | 1 year post-procedure |
| Effectiveness | Rate of successful embolization of the target vessels (MMA trunk and branches) with ONYX base on DSA imaging |
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Inclusion Criteria:
Patients with symptomatic non-acute SDH with mass effect (i.e., chronic or subacute SDH)
Age ≥18 years;
Pre-morbid mRS score 2;
Informed Consent Form (ICF) signed by patient or guardian.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying Mao, PhD | department of Neurosurgery, Huashan Hospital,Fudan University | Principal Investigator |
| Jian Min Liu, MD | Neurovascular Center, Trauma Center, Changhai Hospital, Naval Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39565989 | Derived | Liu J, Ni W, Zuo Q, Yang H, Peng Y, Lin Z, Li Z, Wang J, Zhen Y, Luo J, Lin Y, Chen J, Hua X, Lu H, Zhong M, Liu M, Zhang J, Wang Y, Wan J, Li Y, Li T, Mao G, Zhao W, Gao L, Li C, Chen E, Cheng X, Zhang P, Wang Z, Chen L, Zhang Y, Tian B, Shen F, Lei Y, Wu Y, Li Y, Duan G, Xu L, Lv N, Yu J, Xu X, Du Z, Zhang H, Hu J, Li Z, Yuan Q, Zhou Y, Wu G, Zhang L, Gao C, Dai D, Wu X, Zhang Y, Jiang H, Zhao R, Su J, Xu Y, Ospel JM, Majoie CBLM, Goyal M, Li Q, Yang P, Gu Y, Mao Y; MAGIC-MT Investigators. Middle Meningeal Artery Embolization for Nonacute Subdural Hematoma. N Engl J Med. 2024 Nov 21;391(20):1901-1912. doi: 10.1056/NEJMoa2401201. | |
| 37710274 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 21, 2022 | Apr 28, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 2, 2023 | Dec 2, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| ID | Term |
|---|---|
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D014207 | Trephining |
| D011216 | Practice Management, Medical |
| ID | Term |
|---|---|
| D003399 | Craniotomy |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D020399 | Practice Management |
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| Burr-hole | Procedure | Burr-hole drainage of subdural hematoma |
|
| Medical Management | Other | best medical management |
|
| day 0 |
| Effectiveness | Change in hematoma thickness based on CT/MRI imaging at 90 days post-procedure | 90 days post-procedure |
| Effectiveness | Changes in hematoma volume at 90 days post-procedure | 90 days post-procedure |
| Effectiveness | Change in Midline shift based on CT/MRI imaging at 90 days post-procedure | 90 days post-procedure |
| 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 |
| 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 |
| 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 |
| 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 |
| Safety endpoint | Total patients with SAEs within 90 days post-procedure | 90 days |
| Safety endpoint | Incidence of neurological death within 90 days post-procedure | 90 days |
| Safety endpoint | Incidence of procedural serious complications within 30 days post-procedure:
| 30 days |
| Derived |
| Zuo Q, Ni W, Yang P, Gu Y, Yu Y, Yang H, Majoie CBLM, Goyal M, Liu J, Mao Y; MAGIC-MT investigators. Managing non-acute subdural hematoma using liquid materials: a Chinese randomized trial of middle meningeal artery treatment (MAGIC-MT)-protocol. Trials. 2023 Sep 14;24(1):586. doi: 10.1186/s13063-023-07608-2. |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D011364 |
| Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |