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

NCT04700345 | Unknown DMC FDA Device

• 1 other identifier: MAGIC-MT
• Study Type: interventional
• Target: 722
• Locations: 1 country
• Sites: 1

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.

Conditions

Subdural Hematoma, Non-acute

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Effectiveness

  1 year post-procedure

• Effectiveness

  day 0

• Effectiveness

  90 days post-procedure

• Effectiveness

  90 days post-procedure

• Effectiveness

  90 days post-procedure

Study Arms (2)

Embolization

EXPERIMENTAL

Middle meningeal artery(MMA) embolization

Device: Onyx; Procedure: Burr-hole; Other: Medical Management

No embolization

ACTIVE COMPARATOR

Traditional treatment group

Procedure: Burr-hole; Other: Medical Management

Interventions

Onyx DEVICE

Embolization of the Middle Meningeal Artery using the liquid embolic material

Embolization

Burr-hole PROCEDURE

Burr-hole drainage of subdural hematoma

Embolization; No embolization

Medical Management OTHER

best medical management

Embolization; No embolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with symptomatic non-acute SDH with mass effect (i.e., chronic or subacute SDH)
• Mass effect refers to a shift in midline structure or deformation of local cerebral cortex due to SDH.
• 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.
• Age ≥18 years;
• Pre-morbid mRS score 2;
• Informed Consent Form (ICF) signed by patient or guardian.

You may not qualify if:

• Radiographic imaging indicating massive cerebral infarction with corresponding symptoms;
• Required craniotomy or craniotomy with small bone flap to remove SDH;
• Emergency SDH removal/drainage;
• Bilateral SDH with unknown origin of symptoms;
• Anatomical variations that may affect the safety of MMA embolization (e.g., prominent middle MMA-ophthalmic artery anastomosis);
• Intractable coagulation dysfunction or abnormal platelet count and function (pre-operative International Normalized Ratio \[INR\] \> 1.5 and/or platelet count \< 80109/L);
• Contraindications to cerebral angiography, such as allergy to iodinated contrast agents, renal insufficiency (GFR \< 30 ml/min), etc.;
• Computed tomography (CT) or magnetic resonance imaging (MRI) showing intracranial space-occupying lesions;
• Pregnancy or planning to become pregnant;
• Serious or fatal coexisting disease that may prevent improvement of conditions or completion of follow-up;
• Life expectancy \< 1 year;
• Recent operation unrelated to this study or investigators believe that they will be at higher risks if antiplatelet and/or anticoagulant drugs are discontinued;
• Inability to complete follow-up as required by the protocol;
• Patients participating in other clinical trials;
• Prior surgery or interventional therapy on target SDH;

Sponsors & Collaborators

• Huashan Hospital: lead
• Shanghai Municipal Health Commission: collaborator
• Shanghai Shen Kang Hospital Development Center: collaborator

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (2)

• 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.

  PMID: 39565989 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.

  PMID: 37710274 DERIVED

MeSH Terms

Conditions

Hematoma, Subdural

Interventions

Trephining; Practice Management, Medical

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Hematoma; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Craniotomy; Neurosurgical Procedures; Surgical Procedures, Operative; Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 7, 2021
• Study Start: March 21, 2021
• Primary Completion: August 17, 2023
• Study Completion: June 17, 2024
• Last Updated: April 30, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)