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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06292585
• Other study ID #: AEDH-MT
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Changhai Hospital
• Contact: Pengfei Yang, M.D.
• Phone: 86-21-31161784
• Email: 15921196312[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 168 subjects need to be enrolled, including 84 in the intervention group and 84 in the control group. Primary Outcome： The proportion of patients who die within 72 hours after injury or progress to require craniotomy due to epidural hematoma. Indications for craniotomy surgery：The hematoma volume of acute epidural hematoma is greater than 30ml; Hematoma thickness>15mm; Middle line displacement>5mm; GCS<9 points. Meet any criteria that are deemed to have reached the main outcome. 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. ICU hospitalization days； 4. Success rate of target vessel embolization (MMA main and branch vessels) in DSA imaging; 5. Complications related to interventional surgery; 6. Changes in hematoma volume 30±7 days after injury 7. GCS score at 30±7 days after injury； 8. GOSE score at 6 months after injury 9. All-cause mortality rate at 6 months after injury； 10. EQ-5D scale scores at 6 months after injury； 11. Serious adverse events within 6 months after injury (SAE)； 12. GOSE score at 1 year after injury 13. All-cause mortality rate at 1 year after injury； 14. EQ-5D scale scores at 1 year after injury

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: December 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 or above;

2. Patients with a clear history of head trauma and confirmed acute epidural hematoma by head CT;

3. 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;

4. Randomly within 6 hours after injury, and initiate treatment within 8 hours after injury;

5. Epidural hematoma located on the convex surface of the brain (frontal, temporal, parietal, or occipital);

6. The patient or their representative agrees and signs an informed consent form.

Exclusion Criteria:

1. Patients who require craniotomy surgery to remove hematoma;

2. Bilateral acute epidural hematoma;

3. Combined acute subdural hematoma;

4. There are obvious brain contusions, lacerations, intracerebral hematomas, etc;

5. Combined intracranial tumors and other intracranial space occupying diseases;

6. Severe damage to combined extracranial organs;

7. mRS score before injury > 2;

8. Coagulation dysfunction (preoperative INR>1.5), abnormal platelet count and function (platelet < 80×109/L);

9. There are contraindications for cerebral angiography, such as iodine contrast agent allergy, embolization material allergy, renal dysfunction (GFR<30ml/min), etc;

10. There may be anatomical variations that may affect the safety of MMA embolization surgery and are not suitable for endovascular embolization;

11. 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;

12. Having undergone major surgical procedures within 30 days before surgery, or planning to be hospitalized for surgical treatment within 90 days after surgery;

13. Currently participating in other clinical trials;

14. Pregnant women;

15. Suffering from malignant tumors with an expected lifespan of less than 1 year;

16. Unable to complete follow-up as required by the plan;

17. The physician believes that the patient has other circumstances that are not suitable for participation in this study.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• EpiDural Hematoma
• Hematoma
• Traumatic Brain Injury

Intervention

Procedure:
• MMA embolization plus medical therapy
Patients assigned to the intervention group will receive endovascular embolization treatment within 2 hours after enrollment.

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.

Locations

Country	Name	City	State
China	Changhai hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients who die within 72 hours after injury or progress to require craniotomy due to epidural hematoma.	The proportion of patients who die within 72 hours after injury or progress to require craniotomy due to epidural hematoma.Indications for craniotomy surgery:The hematoma volume of acute epidural hematoma is greater than 30ml; Hematoma thickness>15mm; Middle line displacement>5mm; GCS<9 points. Meet any criteria that are deemed to have reached the main outcome.	Within 72 hours after injury