Acute EpiDural Hematoma Treated With Middle Meningeal Artery Embolization: a Randomized Trial (AEDH-MT)
A prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study.
- EligibilityCriteria: Inclusion Criteria:  Age 18 or above； Patients with a clear history of head trauma and confirmed acute epidural hematoma by head CT； An EDH less than 30 cm3 and with less than a 15-mm thickness and with less than a 5-mm midline shift (MLS) in patients with a GCS score greater than 8 without focal deficit； Randomly within 6 hours after injury, and initiate treatment within 8 hours after injury； Epidural hematoma located on the convex surface of the brain (frontal, temporal, parietal, or occipital)； The patient or their representative agrees and signs an informed consent form.  Exclusion Criteria:  Patients who require craniotomy surgery to remove hematoma； Bilateral acute epidural hematoma； Combined acute subdural hematoma； There are obvious brain contusions, lacerations, intracerebral hematomas, etc； Combined intracranial tumors and other intracranial space occupying diseases； Severe damage to combined extracranial organs； mRS score before injury > 2； Coagulation dysfunction (preoperative INR>1.5), abnormal platelet count and function (platelet < 80×109/L)； There are contraindications for cerebral angiography, such as iodine contrast agent allergy, embolization material allergy, renal dysfunction (GFR<30ml/min), etc； There may be anatomical variations that may affect the safety of MMA embolization surgery and are not suitable for endovascular embolization； Severe comorbidities, such as severe heart failure (ejection fraction<50%), lung failure (partial pressure of blood oxygen<60mmHg), and severe liver dysfunction (prothrombin activity<40%), may prevent improvement of the condition or completion of follow-up； Having undergone major surgical procedures within 30 days before surgery, or planning to be hospitalized for surgical treatment within 90 days after surgery； Currently participating in other clinical trials； Pregnant women； Suffering from malignant tumors with an expected lifespan of less than 1 year； Unable to complete follow-up as required by the plan； The physician believes that the patient has other circumstances that are not suitable for participation in this study. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult