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

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

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury; EpiDural Hematoma
• Intervention / Treatment: Drug: Medical therapy alone; Procedure: MMA embolization plus medical therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 194
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pengfei Yang, M.D.; Phone Number: 86-21-31161784; Email: 15921196312@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Changhai Hospital
      • Contact: Peng-fei Yang, MD; Phone Number: 15921196312; Email: 15921196312@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; MMA embolization	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
Active Comparator: Control group; Conservative treatment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 28 days after injury

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in hematoma volume 7±2 days after injury (or at discharge)	7±2 days after injury (or at discharge)
GCS score at 7±2 days after injury (or at discharge)	7±2 days after injury (or at discharge)
Hematoma volume 28±7 days after injury	28±7 days after injury
GCS score at 28±2 days after injury	28±2 days after injury
ICU hospitalization days	28±2 days after injury
Total hospitalization days	28±2 days after injury
Discharge rehabilitation destination (home vs rehabilitation hospital)	28±2 days after injury
Number of re-hospitalizations	6 months after injury
GOSE score at 3 months after injury	3 months after injury
EQ-5D scale scores at 3 months after injury	3 months after injury
GOSE score at 6 months after injury	6 months after injury
EQ-5D scale scores at 6 months after injury	6 months after injury

Other Outcome Measures

Outcome Measure	Time Frame
Perioperative surgical complications (including craniotomy and neurovascular)	Perioperative period
All-cause mortality rate at 28 ± 7 days after injury	28 ± 7 days after injury
All-cause mortality rate at 3 months after injury	3 months after injury
Serious adverse events (SAEs) 3 months after injury	3 months after injury
All-cause mortality rate at 6 months after injury	6 months after injury

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: The First People's Hospital of Changzhou
• Investigators: Principal Investigator: Jianimin Liu, M.D., Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: AEDH; EDH
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Brain Injuries, Traumatic; Brain Injuries; Hematoma; Hematoma, Epidural, Cranial; Hematoma, Epidural, Spinal
• Other Study ID Numbers: AEDH-MT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to Oriental Collaboration group on Emerging Advanced therapy for Neurovascular diseases Consortium.
• IPD Sharing Time Frame: Data sharing will be available from 12 months after the publication of the main results.
• IPD Sharing Access Criteria: The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered.; The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials.; Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research.; Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection.; The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No