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A multi-center registered study to treat non-acute subdural hematoma combining PVA embolization of middle meningeal artery and atorvastatin

A multi-center registered study to treat non-acute subdural hematoma combining PVA embolization of middle meningeal artery and atorvastatin

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200059208
Enrollment
Unknown
Registered
2022-04-26
Start date
2022-11-06
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Non-acute Subdural Hematoma

Interventions

Middle Meningeal Artery Embolization with PVA+Atorvastatin:None
Traditional Surgery+Atorvastatin:None

Sponsors

The First Affiliated Hospital of Army Medical University PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. Non-acute SDH confirmed by cranial imaging (<30% high-dense components); 3. Symptomatic non-acute SDH in need of surgery, including headache, cognitive impairment, ataxia, epilepsy, focal neurological deficit, or decreased consciousness; 4. Patients fully understand the study and voluntarily participate with signed informed consent.

Exclusion criteria

Exclusion criteria: 1. History of surgical or endovascular treatment for the SDH; 2. In need of urgent subdural hematoma evacuation; 3. Non-acute SDH due to vascular malformation, tumor, arachnoid cyst, spontaneous intracranial hypotension or craniotomy; 4. Severe comorbid illness resulting in life expectancy <1 year; 5. Surgical contraindications, including intolerance of surgery due to poor general health, severe coagulation disorder, etc; 6. Pregnancy or breast-feeding; 7. Poor compliance, unable to follow study protocol.

Design outcomes

Primary

MeasureTime frame
Recurrence rate of hematoma;

Secondary

MeasureTime frame
Reduction in maximum thickness of hematoma;Improvement in functional score (mRS);Incidence of surgical complications;Procedural adverse events;Mortality;

Countries

China

Contacts

Public ContactZhi Chen

The First Affiliated Hospital of Army Medical University PLA

zhichen@tmmu.edu.cn+86 13060207069

Outcome results

None listed

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