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New treatment option for EpiDural Hematoma
Official title Acute EpiDural Hematoma Treated With Middle Meningeal Artery Embolization: a Randomized Trial (AEDH-MT)
ClinicalTrials.gov ID: NCT06292585
What this study is testing
What is Medical therapy alone?
Medical therapy alone is an investigational medicine, being studied as a potential treatment for epidural hematoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)；
You likely can't join if
- 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；
See the full eligibility 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.