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
26 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
Researchers are conducting a prospective, multicenter, randomized controlled study to evaluate treatment options for patients diagnosed with acute epidural hematoma confirmed by cranial CT. The study aims to compare the effects of middle meningeal artery embolization combined with conservative treatment versus conservative treatment alone. The primary goal is to assess the proportion of patients requiring craniotomy within 7 days after injury and to measure neurogenic death within 28 days. Secondary outcomes include changes in hematoma volume, Glasgow Coma Scale (GCS) scores, hospitalization duration, rehabilitation outcomes, re-hospitalizations, and quality of life scores up to 6 months after injury. Participants will be randomly assigned to one of two groups: the intervention group receiving middle meningeal artery embolization within 2 hours of enrollment plus standard conservative treatment, and the control group receiving only the best conservative treatment as recommended by clinical guidelines. Conservative treatment includes medication such as hemostatic, antihypertensive, and symptomatic therapies, consistent across both groups. Treatment must start within 8 hours after injury, with randomization occurring within 6 hours. The study plans to enroll 194 patients, evenly split between the two groups. During the study, patients will undergo neurological examinations and measurements of hematoma size at multiple time points, including 7 days, 28 days, 3 months, and 6 months after injury. Researchers will monitor clinical outcomes such as ICU and total hospitalization days, discharge destinations, and adverse events including surgical complications and mortality rates. Glasgow Outcome Scale-Extended (GOSE) and EQ-5D quality of life scores will be assessed at 3 and 6 months. Safety monitoring includes tracking serious adverse events and all-cause mortality over the study period. Participants will be followed closely for up to 6 months to evaluate recovery and treatment impact.
CONDITIONS
Brief 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 with a clear history of 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 provides informed consent
You will not qualify if you...
- Need for craniotomy surgery to remove hematoma
- Bilateral acute epidural hematoma
- Severe acute subdural hematoma combined
- Brainstem injury
- Obvious brain contusions, lacerations, or intracerebral hematomas
- Intracranial tumors or other space-occupying brain diseases
- Severe damage to extracranial organs
- Modified Rankin Scale score above 2 before injury
- Coagulation dysfunction (INR > 1.5), abnormal platelet counts or function
- Contraindications for cerebral angiography such as allergies to iodine contrast or embolization materials
- Anatomical variations affecting safety of embolization
- Severe comorbidities preventing condition improvement or follow-up
- Major surgery within 30 days before study
- Participation in other clinical trials
- Pregnancy
- Malignant tumors with expected lifespan under 1 year
- Inability to complete follow-up as required
- Other physician-determined unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 hours after injury
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 28 days after injury
Participants receive either middle meningeal artery embolization plus medical therapy or conservative medical therapy alone, starting within 8 hours after injury.
Hospital visits during initial treatment and monitoring period
Duration - Up to 6 months after injury
Participants are assessed for recovery, complications, and functional outcomes up to 6 months after injury.
Visits at approximately 7 days, 28 days, 3 months, and 6 months after injury
Trial Site Locations
Total: 1 location
1
Changhai hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
P
Pengfei Yang, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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