Acute EpiDural Hematoma Treated With Middle Meningeal Artery Embolization: a Randomized Trial (AEDH-MT)
NCT06292585 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194
Last updated 2025-04-04
Summary
A prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study.
Conditions
- EpiDural Hematoma
- Traumatic Brain Injury
Interventions
- PROCEDURE
-
MMA embolization plus medical therapy
Patients assigned to the intervention group will receive endovascular embolization treatment within 2 hours after enrollment. Patients will receive the best conservative treatment recommended by the guidelines after MMA, and conservative treatment will be the same in both groups
- DRUG
-
Medical therapy alone
Patients will receive the best conservative treatment recommended by the guidelines, and conservative treatment will be the same in both groups. Conservative treatment includes medication and general treatment. Drug therapy can be divided into hemostatic treatment, antihypertensive treatment, and symptomatic treatment. Specific local clinical diagnosis and treatment standards shall prevail or refer to corresponding clinical guidelines.
Sponsors & Collaborators
-
The First People's Hospital of Changzhou
collaborator OTHER -
Changhai Hospital
lead OTHER
Principal Investigators
-
Jianimin Liu, M.D. · Changhai Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-02
- Primary Completion
- 2026-06-30
- Completion
- 2026-12-31
Countries
- China
Study Locations
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