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

Not Applicable

Active, not recruiting

• Conditions: Subdural Hematoma, Non-acute
• Interventions: Device: Onyx; Procedure: Burr-hole; Other: Medical Management

• Registration Number: NCT04700345
• Lead Sponsor: Huashan Hospital

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.

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 Timeline

• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-07
• Study Start: 2021-03-21
• Status Verified: 2023-08
• Primary Completion: 2023-08-17
• Last Update Submitted: 2024-04-28
• Last Update Posted: 2024-04-30
• Study Completion: 2024-06-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 722

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Embolization	Burr-hole	Middle meningeal artery(MMA) embolization
No embolization	Medical Management	Traditional treatment group
Embolization	Onyx	Middle meningeal artery(MMA) embolization
No embolization	Burr-hole	Traditional treatment group
Embolization	Medical Management	Middle meningeal artery(MMA) embolization

Primary Outcome Measures

Name	Time	Method
Incidence of symptomatic SDH recurrence/ progression within 90 days post-procedure	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

Name	Time	Method
Effectiveness	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
Safety endpoint	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

Trial Locations

Locations (1)

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China