Randomized Study of Middle Meningeal Artery Embolization Versus Conservative Treatment for Adults with Acute Epidural Hematoma

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.

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