NCT06292585

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 194 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study.

Detailed description

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.

Conditions

• EpiDural Hematoma
• Traumatic Brain Injury

Interventions

Type	Name	Description
PROCEDURE	MMA embolization plus medical therapy	Patients assigned to the intervention group will receive endovascular embolization treatment within 2 hours after enrollment. Patients will receive the best conservative treatment recommended by the guidelines after MMA, and conservative treatment will be the same in both groups
DRUG	Medical therapy alone	Patients will receive the best conservative treatment recommended by the guidelines, and conservative treatment will be the same in both groups. Conservative treatment includes medication and general treatment. Drug therapy can be divided into hemostatic treatment, antihypertensive treatment, and symptomatic treatment. Specific local clinical diagnosis and treatment standards shall prevail or refer to corresponding clinical guidelines.

Timeline

• Start date: 2024-09-02
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-03-05
• Last updated: 2025-04-04

Locations

1 site across 1 country: China