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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04700345
Recruitment Status : Not yet recruiting
First Posted : January 7, 2021
Last Update Posted : January 7, 2021
Sponsor:
Collaborators:
Changhai Hospital
Shanghai Shen Kang Hospital Development Center
Information provided by (Responsible Party):
Ying Mao, Huashan Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Subdural Hematoma, Non-acute Device: Onyx Procedure: Burr-hole Other: Medical Management Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 722 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Managing Non-acute Subdural Hematoma Using Liquid Materials：a Chinese Randomized Trial of MMA Treatment
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : June 2022
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Effectiveness [ Time Frame: 1 year post-procedure ]
    Incidence of SDH recurrence/ progression at 1 year post-procedure

  2. Effectiveness [ Time Frame: day 0 ]
    Rate of successful embolization of the target vessels (MMA trunk and branches) with ONYX base on DSA imaging

  3. Effectiveness [ Time Frame: 90 days post-procedure ]
    Change in hematoma thickness based on CT/MRI imaging at 90 days post-procedure

  4. Effectiveness [ Time Frame: 90 days post-procedure ]
    Changes in hematoma volume at 90 days post-procedure

  5. Effectiveness [ Time Frame: 90 days post-procedure ]
    Change in Midline shift based on CT/MRI imaging at 90 days post-procedure

  6. Effectiveness [ Time Frame: 90 days and 1 year post-procedure ]
    Change in the Modified Rankin Scale score (mRS) Grade 0 (no symptoms) to 6 (death) at 90 days and 1 year post-procedure

  7. Effectiveness [ Time Frame: 90 days and 1 year post-procedure ]
    Percentage of patients with favorable functional outcome defined as Modified Rankin Scale of 0 to 3 at 90 days and 1year post-procedure

  8. Effectiveness [ Time Frame: 90 days and 1 year post-procedure ]
    Percentage of patients with good functional outcome defined as Modified Rankin Scale of 0 to 2 at 90 days and 1 year post-procedure

  9. Effectiveness [ Time Frame: 90 days and 1 year post-procedure ]
    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

  10. Safety endpoint [ Time Frame: 90 days ]
    Total patients with SAEs within 90 days post-procedure

  11. Safety endpoint [ Time Frame: 90 days ]
    Incidence of neurological death within 90 days post-procedure

  12. Safety endpoint [ Time Frame: 30 days ]

    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Symptomatic non-acute SDH with mass effect (i.e. chronic or subacute SDH, fulfilling one or more of the following criteria)

    1. <30% hyperdense components
    2. septations that are indicative of a chronic SDH
    3. known from previous (>2 weeks old) brain imaging Mass effect is defined as midline shift or deformation of the normal contour of the brain (i.e. flattening) due to the SDH.

    Symptomatic SDH is defined as an SDH that fulfills one or more of the following criteria AND shows neurological symptoms (headache, short-term cognitive decline, speech difficulty or aphasia, gait impairment, focal weakness, sensory deficits, seizures) that are attributable to the hematoma

  2. Age 18 or higher
  3. Independent functional status in activities of daily living with mRS score ≤ 2 prior to the symptom.
  4. Signed informed consent or appropriate signed deferral of consent where approved.

Exclusion Criteria:

  1. Qualifying imaging reveals clear hypodense demarcation of the majority of the territory of symptomatic intracranial occlusion.
  2. Subject requires (in the opinion of the treating surgeon) a full or mini craniotomy.
  3. Subject with urgent or emergent subdural hematoma evacuation needed.
  4. Bilateral SDH with unknown origin of symptoms.
  5. Any evidence of anatomical variants that might render safe MMA embolization impossible (e.g. prominent MMA-ophtalmic artery anastomoses)
  6. Coagulation and platelet disorders, or antiplatelet medication that is not easily correctable with INR >1.5 and/or platelet count < 80.000.
  7. Contraindications for neurangiography, e.g. iodinated contrast allergy, renal insufficiency with GFR < 30 ml/min.
  8. CT or MRI evidence of intra-cranial tumor or mass lesion.
  9. Pregnancy; if a woman is of child-bearing potential a urine or serum beta HCG test is positive.
  10. Patient has a severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
  11. Life expectancy <1 year.
  12. High risk of removal from antiplatelet and/or anticoagulant medical therapy for recent procedure or other reasons.
  13. Patient cannot complete follow-up for any reason. (eg. visiting from another city, illness, incarceration in prison etc.)
  14. Participation in another clinical trial investigating a drug, medical device, or a medical procedure that might confound treatment and outcomes related to the current trial.
  15. Previous surgery or endovascular treatment for the SDH under investigation
  16. Unable to undergo MMA embolization prior to surgical treatment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04700345


Contacts
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Contact: Yuxiang Gu, PhD +8613801847125 guyuxiang1972@26.com
Contact: Wei Ni, PhD hsniwei@fudan.edu.cn

Locations
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China, Shanghai
Huashan Hospital
Shanghai, Shanghai, China
Contact: Yuxiang Gu         
Principal Investigator: Ying Mao, MD,PhD         
Principal Investigator: Jianmin Liu, MD         
Sponsors and Collaborators
Huashan Hospital
Changhai Hospital
Shanghai Shen Kang Hospital Development Center
Investigators
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Principal Investigator: Ying Mao, PhD department of Neurosurgery, Huashan Hospital,Fudan University
Principal Investigator: Jian Min Liu, MD department of Neurosurgery, Changhai Hospital of the Second Military Medical University
More Information
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Responsible Party: Ying Mao, MD, PhD, Huashan Hospital
ClinicalTrials.gov Identifier: NCT04700345    
Other Study ID Numbers: MAGIC-MT
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Hematoma, Subdural
Hematoma
Hemorrhage
Pathologic Processes
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
Wounds and Injuries