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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Subdural Hematoma, Non-acute
• Intervention / Treatment: Device: Onyx; Procedure: Burr-hole; Other: Medical Management

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 Type: Interventional
• Enrollment (Estimated): 722
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Huashan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Embolization; Middle meningeal artery(MMA) embolization	Device: Onyx; Embolization of the Middle Meningeal Artery using the liquid embolic material; Procedure: Burr-hole; Burr-hole drainage of subdural hematoma; Other: Medical Management; best medical management
Active Comparator: No embolization; Traditional treatment group	Procedure: Burr-hole; Burr-hole drainage of subdural hematoma; Other: Medical Management; best medical management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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: 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

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Collaborators: Shanghai Shen Kang Hospital Development Center; Shanghai Municipal Health Commission
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2021
• Primary Completion (Actual): August 17, 2023
• Study Completion (Estimated): June 17, 2024

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 28, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural
• Other Study ID Numbers: MAGIC-MT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes