RecruitingNot ApplicableNCT06292585

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

Sponsor

Changhai Hospital

Enrollment

194 participants

Start Date

Sep 2, 2024

Study Type

INTERVENTIONAL

Conditions

Traumatic Brain Injury Epidural Hematoma

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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.

Exclusion Criteria18

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；
Suffering from malignant tumors with an expected lifespan of less than 1 year；
Unable to complete follow-up as required by the protocol；
The physician believes that the patient has other circumstances that are not suitable for participation in this study.

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Interventions

PROCEDUREMMA 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

DRUGMedical 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.