Acute EpiDural Hematoma Treated With Middle Meningeal Artery Embolization: a Randomized Trial (AEDH-MT)

This study is a prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study. All patients diagnosed with acute epidural hematoma through cranial CT will undergo neurological examination and measurement of hematoma size. For patients who meet the inclusion criteria, they will be randomly assigned 1:1 to the middle meningeal artery embolization group (intervention group) and the conservative treatment group (control group). A total of 194 subjects need to be enrolled, including 97 in the intervention group and 97 in the control group. Primary Outcome： The proportion of patients who require craniotomy due to the progression of epidural hematoma 7 days after injury\*, and neurogenic death 28 days after injury. \*This includes patients who have actually undergone surgery and those who were deemed necessary by the committee but did not undergo surgery for various reasons. Secondary outcome： 1. Changes in hematoma volume 7±2 days after injury (or at discharge) 2. GCS score at 7±2 days after injury (or at discharge)； 3. Hematoma volume 28±7 days after injury 4. GCS score at 28±2 days after injury； 5. ICU hospitalization days； 6. Total hospitalization days; 7. Discharge rehabilitation destination (home vs rehabilitation hospital) 8. Number of re-hospitalizations； 9. GOSE score at 3 months after injury 10. EQ-5D scale scores at 3 months after injury； 11. GOSE score at 6 months after injury 12. EQ-5D scale scores at 6 months after injury Safety outcome: 1. Perioperative surgical complications (including craniotomy and neurovascular) 2. All-cause mortality rate at 28 ± 7 days after injury; 3. All-cause mortality rate at 3 months after injury; 4. Serious adverse events (SAEs) 3 months after injury; 5. All-cause mortality rate at 6 months after injury; 6. Serious adverse events (SAEs) 6 months after injury.