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

NCT ID: NCT04700345

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 722 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-21
• Study Completion Date: 2024-06-17

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.

Conditions

Subdural Hematoma, Non-acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Embolization

Middle meningeal artery(MMA) embolization

Group Type: EXPERIMENTAL

Onyx

Intervention Type: DEVICE

Embolization of the Middle Meningeal Artery using the liquid embolic material

Burr-hole

Intervention Type: PROCEDURE

Burr-hole drainage of subdural hematoma

Medical Management

Intervention Type: OTHER

best medical management

No embolization

Traditional treatment group

Group Type: ACTIVE_COMPARATOR

Burr-hole

Intervention Type: PROCEDURE

Burr-hole drainage of subdural hematoma

Medical Management

Intervention Type: OTHER

best medical management

Interventions

Onyx

Embolization of the Middle Meningeal Artery using the liquid embolic material

Intervention Type: DEVICE

Burr-hole

Burr-hole drainage of subdural hematoma

Intervention Type: PROCEDURE

Medical Management

best medical management

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Municipal Health Commission

UNKNOWN

Sponsor Role: collaborator

Shanghai Shen Kang Hospital Development Center

OTHER

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ying Mao

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ying Mao, PhD

Role: PRINCIPAL_INVESTIGATOR

department of Neurosurgery, Huashan Hospital,Fudan University

Jian Min Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Neurovascular Center, Trauma Center, Changhai Hospital, Naval Medical University

Locations

Huashan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 39565989 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37710274 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MAGIC-MT

Identifier Type: -

Identifier Source: org_study_id