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

April 28, 2024 updated by: Ying Mao, Huashan Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
722

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effectiveness
Time Frame: 1 year post-procedure
Incidence of SDH recurrence/ progression at 1 year post-procedure
1 year post-procedure
Effectiveness
Time Frame: day 0
Rate of successful embolization of the target vessels (MMA trunk and branches) with ONYX base on DSA imaging
day 0
Effectiveness
Time Frame: 90 days post-procedure
Change in hematoma thickness based on CT/MRI imaging at 90 days post-procedure
90 days post-procedure
Effectiveness
Time Frame: 90 days post-procedure
Changes in hematoma volume at 90 days post-procedure
90 days post-procedure
Effectiveness
Time Frame: 90 days post-procedure
Change in Midline shift based on CT/MRI imaging at 90 days post-procedure
90 days post-procedure
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
90 days and 1 year post-procedure
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
90 days and 1 year post-procedure
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
90 days and 1 year post-procedure
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
90 days and 1 year post-procedure
Safety endpoint
Time Frame: 90 days
Total patients with SAEs within 90 days post-procedure
90 days
Safety endpoint
Time Frame: 90 days
Incidence of neurological death within 90 days post-procedure
90 days
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huashan Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Shen Kang Hospital Development Center
Shanghai Municipal Health Commission

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 17, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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