NCT06292585 Acute EpiDural Hematoma Treated With Middle Meningeal Artery Embolization: a Randomized Trial (AEDH-MT)
| NCT ID | NCT06292585 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Changhai Hospital |
| Condition | EpiDural Hematoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 194 participants |
| Start Date | 2024-09-02 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 194 participants in total. It began in 2024-09-02 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study.
Eligibility Criteria
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.
Contact & Investigator
Jianimin Liu, M.D.
PRINCIPAL INVESTIGATOR
Changhai Hospital
Frequently Asked Questions
Who can join the NCT06292585 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying EpiDural Hematoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06292585 currently recruiting?
Yes, NCT06292585 is actively recruiting participants. Contact the research team at 15921196312@163.com for enrollment information.
Where is the NCT06292585 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06292585 clinical trial?
NCT06292585 is sponsored by Changhai Hospital. The principal investigator is Jianimin Liu, M.D. at Changhai Hospital. The trial plans to enroll 194 participants.