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

NCT06292585 | Recruiting DMC

• 1 other identifier: AEDH-MT
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

EpiDural Hematoma; Traumatic Brain Injury

Keywords

AEDH; EDH

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

Other Outcomes (5)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

MMA embolization

Procedure: MMA embolization plus medical therapy

Control group

ACTIVE COMPARATOR

Conservative treatment

Drug: Medical therapy alone

Interventions

MMA embolization plus medical therapy PROCEDURE

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

Intervention group

Medical therapy alone DRUG

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or above；
• Patients with a clear history of head trauma and confirmed acute epidural hematoma by head CT；
• Cases that the case screening committee deems suitable for conservative treatment\*；
• 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. \* 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.

You may not qualify if:

• Patients who require craniotomy surgery to remove hematoma；
• Bilateral acute epidural hematoma；
• Combined severe acute subdural hematoma；
• Brainstem injury；
• 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 \> 2 before injury；
• 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 etc.；
• There may be anatomical variations that may affect the safety of MMA embolization surgery and are not suitable for endovascular embolization；
• Severe comorbidities, may prevent improvement of the condition or completion of follow-up；
• Having undergone major surgical procedures within 30 days before surgery；
• Currently participating in other clinical trials；
• Pregnant women；

Sponsors & Collaborators

• Changhai Hospital: lead
• The First People's Hospital of Changzhou: collaborator

Study Sites (1)

Changhai hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Hematoma, Epidural, Spinal; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Hematoma; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jianimin Liu, M.D.

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengfei Yang, M.D.

CONTACT

86-21-31161784; 15921196312@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: September 2, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data sharing will be available from 12 months after the publication of the main results.
• Access Criteria: 1. 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. 2. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. 3. 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. 4. 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. 5. The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.

Locations

CN (1)