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

RecruitingNAAges 18 Years - anyAllChanghai Hospital
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • MMA embolization plus medical therapy
  • Medical therapy alone
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Where

1 site
Changhai hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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