RecruitingNot Applicable

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

China194 participantsStarted 2024-09-02

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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；

What they're measuring

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

Timeframe: Within 28 days after injury

Trial details

NCT IDNCT06292585

SponsorChanghai Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Pengfei Yang, M.D.

86-21-31161784 15921196312@163.com

View on ClinicalTrials.gov More EpiDural Hematoma trials