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Active, not recruitingNCT04700345MAGIC-MTUpdated Apr 30, 2024

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

An interventional study of Onyx and Burr-hole in Subdural Hematoma, Non-acute, sponsored by Huashan Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-30.

Sponsored by Huashan Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
722
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Subdural Hematoma, Non-acute
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
722 participants (estimated)

Study arms

  • Experimental
    Embolization

    Middle meningeal artery(MMA) embolization

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

  • Active comparator
    No embolization

    Traditional treatment group

    Procedure: Burr-hole · Other: Medical Management

Interventions

  • DeviceOnyx

    Embolization of the Middle Meningeal Artery using the liquid embolic material

  • ProcedureBurr-hole

    Burr-hole drainage of subdural hematoma

  • OtherMedical Management

    best medical management

05

What researchers measure

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

    Time frame: 90 days

Secondary outcomes

  1. Effectiveness

    Incidence of SDH recurrence/ progression at 1 year post-procedure

    Time frame: 1 year post-procedure

  2. Effectiveness

    Rate of successful embolization of the target vessels (MMA trunk and branches) with ONYX base on DSA imaging

    Time frame: day 0

  3. Effectiveness

    Change in hematoma thickness based on CT/MRI imaging at 90 days post-procedure

    Time frame: 90 days post-procedure

  4. Effectiveness

    Changes in hematoma volume at 90 days post-procedure

    Time frame: 90 days post-procedure

  5. Effectiveness

    Change in Midline shift based on CT/MRI imaging at 90 days post-procedure

    Time frame: 90 days post-procedure

  6. Effectiveness

    Change in the Modified Rankin Scale score (mRS) Grade 0 (no symptoms) to 6 (death) at 90 days and 1 year post-procedure

    Time frame: 90 days and 1 year post-procedure

  7. Effectiveness

    Percentage of patients with favorable functional outcome defined as Modified Rankin Scale of 0 to 3 at 90 days and 1year post-procedure

    Time frame: 90 days and 1 year post-procedure

  8. 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

    Time frame: 90 days and 1 year post-procedure

  9. 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

    Time frame: 90 days and 1 year post-procedure

  10. Safety endpoint

    Total patients with SAEs within 90 days post-procedure

    Time frame: 90 days

  11. Safety endpoint

    Incidence of neurological death within 90 days post-procedure

    Time frame: 90 days

  12. 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

    Time frame: 30 days

06

Study locations

1 site
  • Huashan Hospital
    Shanghai, Shanghai, China
07

References and documents

Study documents

  • Study protocol · Sep 21, 2022
  • Statistical analysis plan · Dec 2, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04700345
Lead sponsor
Huashan Hospital
Collaborators
Shanghai Municipal Health Commission, Shanghai Shen Kang Hospital Development Center
Responsible party
Ying Mao (MD, PhD, Huashan Hospital) — Principal investigator
First posted
Jan 7, 2021
Start date
Mar 21, 2021
Primary completion
Aug 17, 2023
Completion
Jun 17, 2024 (estimated)
Last update
Apr 30, 2024

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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