Treatment of acute epidural hematoma using middle meningeal artery embolization

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

This study is testing if a new procedure using middle meningeal artery embolization can help people with acute epidural hematoma recover better than standard treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 194 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06292585 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of middle meningeal artery embolization compared to conservative treatment for patients with acute epidural hematoma. Patients diagnosed with this condition through cranial CT will be randomly assigned to either the intervention group receiving embolization or the control group receiving standard medical therapy. The study aims to enroll 194 subjects and assess outcomes such as the need for craniotomy, changes in hematoma volume, and overall recovery at various time points. The trial will also monitor safety and quality of life measures post-treatment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of acute epidural hematoma following head trauma.

Not a fit: Patients with contraindications for embolization or those with severe neurological deficits may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce the need for surgical intervention and improve recovery outcomes for patients with acute epidural hematoma.

How similar studies have performed: While the approach of embolization for this condition is innovative, similar studies have shown promise in treating other types of hemorrhages, suggesting potential for success.

Eligibility criteria

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. Cases that the case screening committee deems suitable for conservative treatment\*；
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. \* The case screening committee is composed of three senior neurosurgeons, with two of them jointly deciding whether conservative treatment is possible. If there is a disagreement, the third doctor will make the final judgment. Including but not limited to the following two situations: 1. Hematoma volume\<30ml, hematoma thickness\<15mm, midline shift (MLS) \<5mm, GCS score\>8, and no focal neurological deficit; 2. If the GCS score is ≥ 13, the imaging standards can be appropriately relaxed.

Exclusion criteria：

1. Patients who require craniotomy surgery to remove hematoma；
2. Bilateral acute epidural hematoma；
3. Combined severe acute subdural hematoma；
4. Brainstem injury；
5. There are obvious brain contusions, lacerations, intracerebral hematomas, etc；
6. Combined intracranial tumors and other intracranial space occupying diseases；
7. Severe damage to combined extracranial organs；
8. mRS score \> 2 before injury；
9. Coagulation dysfunction (preoperative INR\>1.5), abnormal platelet count and function (platelet \< 80×109/L)；
10. There are contraindications for cerebral angiography, such as iodine contrast agent allergy, embolization material allergy etc.；
11. There may be anatomical variations that may affect the safety of MMA embolization surgery and are not suitable for endovascular embolization；
12. Severe comorbidities, may prevent improvement of the condition or completion of follow-up；
13. Having undergone major surgical procedures within 30 days before surgery；
14. Currently participating in other clinical trials；
15. Pregnant women；
16. Suffering from malignant tumors with an expected lifespan of less than 1 year；
17. Unable to complete follow-up as required by the protocol；
18. The physician believes that the patient has other circumstances that are not suitable for participation in this study.

Where this trial is running

Shanghai, Shanghai Municipality

• Changhai hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jianimin Liu, M.D. — Changhai Hospital
• Study coordinator: Pengfei Yang, M.D.

Conditions EpiDural Hematoma; Traumatic Brain Injury; AEDH; EDH