Subdural Hematoma, Non-acuteMAGIC-MTNCT04700345
Managing Non-acute Subdural Hematoma Using Liquid Materials：a Chinese Randomized Trial of MMA Treatment
A study testing Onyx, Burr-hole and Medical Management in people with Subdural Hematoma, Non-acute, run by Huashan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subdural Hematoma, Non-acute
- What is being tested?
- Onyx, Burr-hole and Medical Management
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 722 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2021to 17 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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;
- Inability to complete MMA embolization before trepanation and drainage.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Onyx, Burr-hole, Medical Management
- Medical subject headings
- Hematoma, Subdural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnyxDevice
Embolization of the Middle Meningeal Artery using the liquid embolic material
Burr-holeProcedure or surgery
Burr-hole drainage of subdural hematoma
Medical ManagementOther
best medical management
| Study group | Role | What they receive |
|---|---|---|
| Embolization | Experimental | Middle meningeal artery(MMA) embolization Receives: Device: Onyx; Procedure: Burr-hole; Other: Medical Management |
| No embolization | Active comparator | Traditional treatment group Receives: Procedure: Burr-hole; Other: Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (12)
Effectiveness
Incidence of SDH recurrence/ progression at 1 year post-procedure
Measured: 1 year post-procedure
Effectiveness
Rate of successful embolization of the target vessels (MMA trunk and branches) with ONYX base on DSA imaging
Measured: day 0
Effectiveness
Change in hematoma thickness based on CT/MRI imaging at 90 days post-procedure
Measured: 90 days post-procedure
Effectiveness
Changes in hematoma volume at 90 days post-procedure
Measured: 90 days post-procedure
Effectiveness
Change in Midline shift based on CT/MRI imaging at 90 days post-procedure
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 90 days and 1 year post-procedure
Safety endpoint
Total patients with SAEs within 90 days post-procedure
Measured: 90 days
Safety endpoint
Incidence of neurological death within 90 days post-procedure
Measured: 90 days
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start21 Mar 2021
- Primary completion17 Aug 2023
- Study completion17 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Subdural Hematoma, Non-acuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 722 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Health Commission, Shanghai Shen Kang Hospital Development Center
- Responsible party
- Principal investigator, Ying Mao, Huashan Hospital
- Investigators
- Ying Mao, PhD, Principal investigator, department of Neurosurgery, Huashan Hospital,Fudan UniversityJian Min Liu, MD, Principal investigator, Neurovascular Center, Trauma Center, Changhai Hospital, Naval Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700345
- Sponsor's protocol ID
- MAGIC-MT
- Acronym
- MAGIC-MT
- Status last verified
- Aug 2023
- First submitted
- 4 Jan 2021
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Weng R, Su J, Zhou S, Yang H, Jiang H, Gao X, Gao C, Hao J, Zhang M, Wang D, Jiang Z, Fei Y, Yu Z, Liu W, Ni W, Gu Y; MAGIC-MT Investigators. Hyperdense Capsule Sign at Noncontrast CT as an Indication for Middle Meningeal Artery Embolization for Nonacute Subdural Hematomas: A MAGIC-MT Trial Post Hoc Analysis. Radiology. 2026 Jul;320(1):e251512. doi: 10.1148/radiol.251512.
PubMed 42411965Liu 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.
PubMed 39565989Zuo 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.
PubMed 37710274
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Non-acute Subdural Hematoma Using Liquid Materials：a Chinese Randomized Trial of MMA Treatment
- ClinicalTrials.gov ID
- NCT04700345
- Acronym / sponsor ID
- MAGIC-MT / MAGIC-MT
- Conditions
- Subdural Hematoma, Non-acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 722 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Shanghai Municipal Health Commission, Shanghai Shen Kang Hospital Development Center
- Study start
- 21 Mar 2021 (actual)
- Primary completion
- 17 Aug 2023 (actual)
- Study completion
- 17 Jun 2024 (estimated)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Embolization | Experimental | Device: Onyx, Procedure: Burr-hole, Other: Medical ManagementMiddle meningeal artery(MMA) embolization |
| No embolization | Active comparator | Procedure: Burr-hole, Other: Medical ManagementTraditional treatment group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnyxEmbolization of the Middle Meningeal Artery using the liquid embolic material | Device | Embolization |
| Burr-holeBurr-hole drainage of subdural hematoma | Procedure or surgery | Embolization, No embolization |
| Medical Managementbest medical management | Other | Embolization, No embolization |
Primary outcome
Incidence of symptomatic SDH recurrence/ progression within 90 days post-procedure
Time frame: 90 days
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
12 secondary outcomes
Effectiveness
Time frame: 1 year post-procedure
Effectiveness
Time frame: day 0
Effectiveness
Time frame: 90 days post-procedure
Effectiveness
Time frame: 90 days post-procedure
Effectiveness
Time frame: 90 days post-procedure
Effectiveness
Time frame: 90 days and 1 year post-procedure
Effectiveness
Time frame: 90 days and 1 year post-procedure
Effectiveness
Time frame: 90 days and 1 year post-procedure
Effectiveness
Time frame: 90 days and 1 year post-procedure
Safety endpoint
Time frame: 90 days
Safety endpoint
Time frame: 90 days
Safety endpoint
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Derived from this study: PubMed 42411965Weng R, Su J, Zhou S, Yang H, Jiang H, Gao X, Gao C, Hao J, Zhang M, Wang D, Jiang Z, Fei Y, Yu Z, Liu W, Ni W, Gu Y; MAGIC-MT Investigators. Hyperdense Capsule Sign at Noncontrast CT as an Indication for Middle Meningeal Artery Embolization for Nonacute Subdural Hematomas: A MAGIC-MT Trial Post Hoc Analysis. Radiology. 2026 Jul;320(1):e251512. doi: 10.1148/radiol.251512.
- Derived from this study: PubMed 39565989Liu 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.
- Derived from this study: PubMed 37710274Zuo 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Mao, PhD principal investigator
department of Neurosurgery, Huashan Hospital,Fudan University
Jian Min Liu, MD principal investigator
Neurovascular Center, Trauma Center, Changhai Hospital, Naval Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Onyx, Burr-hole and Medical Management in people with Subdural Hematoma, Non-acute, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of symptomatic SDH recurrence/ progression within 90 days post-procedure (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04700345, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.