💬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.