Actively Recruiting
Acute EpiDural Hematoma Treated With Middle Meningeal Artery Embolization: a Randomized Trial (AEDH-MT)
Led by Changhai Hospital · Updated on 2025-04-04
194
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
C
Changhai Hospital
Lead Sponsor
T
The First People's Hospital of Changzhou
Collaborating Sponsor
AI-Summary
What this Trial Is About
A prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study.
CONDITIONS
Official Title
Acute EpiDural Hematoma Treated With Middle Meningeal Artery Embolization: a Randomized Trial (AEDH-MT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or above
- Confirmed acute epidural hematoma by head CT after clear head trauma
- Suitable for conservative treatment as decided by a committee of neurosurgeons
- Randomization within 6 hours after injury and treatment initiation within 8 hours
- Epidural hematoma located on the convex surface of the brain (frontal, temporal, parietal, or occipital)
- Patient or representative agrees and signs informed consent
You will not qualify if you...
- Requires craniotomy surgery to remove hematoma
- Bilateral acute epidural hematoma
- Severe acute subdural hematoma
- Brainstem injury
- Obvious brain contusions, lacerations, or intracerebral hematomas
- Intracranial tumors or other space occupying diseases
- Severe damage to extracranial organs
- Modified Rankin Scale score greater than 2 before injury
- Coagulation dysfunction (preoperative INR >1.5), abnormal platelet count or function (platelet < 80×10⁹/L)
- Contraindications for cerebral angiography such as allergy to iodine contrast or embolization materials
- Anatomical variations unsuitable for middle meningeal artery embolization
- Severe comorbidities preventing condition improvement or follow-up
- Major surgery within 30 days before surgery
- Currently participating in other clinical trials
- Pregnant women
- Malignant tumors with life expectancy less than 1 year
- Unable to complete follow-up as required
- Other conditions deemed unsuitable by physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Changhai hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
P
Pengfei Yang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here