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Middle meningeal artery embolization versus surgery for chronic subdural hematoma: a multicenter, randomized, controlled clinical study in China

Middle meningeal artery embolization versus surgery for chronic subdural hematoma: a multicenter, randomized, controlled clinical study in China

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096266
Enrollment
Unknown
Registered
2025-01-21
Start date
2025-02-04
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic subdural hematoma

Interventions

Experimental group (MMA embolization + standard drug adjuvant therapy):MMA embolization + standard drug adjuvant therapy
Control group: (surgery + standard drug adjuvant therapy):surgery + standard drug adjuvant therapy

Sponsors

The First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. 18 15mm, or midline deviation > 5mm; 3) Symptoms include headache, cognitive decline, ataxia, epilepsy, dysfunction of the kitchen God channel, or decreased level of consciousness; 3) Patients fully understand the nature of the study, voluntarily participate and sign the informed consent; 4) Subjects are able and willing to perform all follow-up.

Exclusion criteria

Exclusion criteria: 1.Previous history of surgery or endovascular treatment of chronic subdural hematoma; 2.Chronic subdural hematoma requiring urgent surgical evacuation; 3.Chronic subdural hematoma secondary to vascular disease, arachnoid cyst, intracranial tumor or craniotomy; 4.Contraindications to cerebral angiography; 5.Intolerance to embolization surgery; 6.Vascular variation or abnormal anastomosis precludes embolization surgery; 7.People who are allergic to the drug components of this study or have an allergic constitution; 8.Severe hepatic impairment with ALT or AST > 3 times the upper limit of normal; 9.Serious diseases involving respiratory, circulatory, digestive, urinary, endocrine, immune and hematologic diseases, with a life expectancy of less than 1 year; 10.There are contraindications to surgery, including poor health and inability to tolerate surgery, severe coagulation disorders, etc; 11.Pregnancy and lactation; 12.Those who have poor compliance and cannot complete the trial according to the study protocol; 13.Participation in other clinical trials (excludes: observational studies that do not involve medical interventions, such as natural history and/or epidemiological studies of the disease).

Design outcomes

Primary

MeasureTime frame
Hematoma recurrence rate;

Secondary

MeasureTime frame
Change in maximum thickness of hematoma;Midline shift;Feature scoring;Incidence of adverse events;Mortality;Total length of hospital stay and hospital expenses;

Countries

China

Contacts

Public ContactZhi Chen

The First Affiliated Hospital of Army Medical University

2911017@qq.com+86 23 68765913

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026