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

Обзор

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

Подробное описание

This study is a prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study.

All patients diagnosed with acute epidural hematoma through cranial CT will undergo neurological examination and measurement of hematoma size. For patients who meet the inclusion criteria, they will be randomly assigned 1:1 to the middle meningeal artery embolization group (intervention group) and the conservative treatment group (control group). A total of 194 subjects need to be enrolled, including 97 in the intervention group and 97 in the control group.

Primary Outcome： 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.

\*This includes patients who have actually undergone surgery and those who were deemed necessary by the committee but did not undergo surgery for various reasons.

Secondary outcome：

1. Changes in hematoma volume 7±2 days after injury (or at discharge) 2. GCS score at 7±2 days after injury (or at discharge)； 3. Hematoma volume 28±7 days after injury 4. GCS score at 28±2 days after injury； 5. ICU hospitalization days； 6. Total hospitalization days; 7. Discharge rehabilitation destination (home vs rehabilitation hospital) 8. Number of re-hospitalizations； 9. GOSE score at 3 months after injury 10. EQ-5D scale scores at 3 months after injury； 11. GOSE score at 6 months after injury 12. EQ-5D scale scores at 6 months after injury

Safety outcome:

1. Perioperative surgical complications (including craniotomy and neurovascular) 2. All-cause mortality rate at 28 ± 7 days after injury; 3. All-cause mortality rate at 3 months after injury; 4. Serious adverse events (SAEs) 3 months after injury; 5. All-cause mortality rate at 6 months after injury; 6. Serious adverse events (SAEs) 6 months after injury.

Вмешательства

• Процедура MMA embolization plus medical therapy
  Patients assigned to the intervention group will receive endovascular embolization treatment within 2 hours after enrollment. Patients will receive the best conservative treatment recommended by the guidelines after MMA, and conservative treatment will be the same in both groups
• Препарат Medical therapy alone
  Patients will receive the best conservative treatment recommended by the guidelines, and conservative treatment will be the same in both groups. Conservative treatment includes medication and general treatment. Drug therapy can be divided into hemostatic treatment, antihypertensive treatment, and symptomatic treatment. Specific local clinical diagnosis and treatment standards shall prevail or refer to corresponding clinical guidelines.

Первичные конечные точки

• 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 [Срок оценки: Within 28 days after injury]

Вторичные конечные точки (12)

• Changes in hematoma volume 7±2 days after injury (or at discharge) [Срок оценки: 7±2 days after injury (or at discharge)]
• GCS score at 7±2 days after injury (or at discharge) [Срок оценки: 7±2 days after injury (or at discharge)]
• Hematoma volume 28±7 days after injury [Срок оценки: 28±7 days after injury]
• GCS score at 28±2 days after injury [Срок оценки: 28±2 days after injury]
• ICU hospitalization days [Срок оценки: 28±2 days after injury]
• Total hospitalization days [Срок оценки: 28±2 days after injury]
• Discharge rehabilitation destination (home vs rehabilitation hospital) [Срок оценки: 28±2 days after injury]
• Number of re-hospitalizations [Срок оценки: 6 months after injury]
• GOSE score at 3 months after injury [Срок оценки: 3 months after injury]
• EQ-5D scale scores at 3 months after injury [Срок оценки: 3 months after injury]
• GOSE score at 6 months after injury [Срок оценки: 6 months after injury]
• EQ-5D scale scores at 6 months after injury [Срок оценки: 6 months after injury]

Критерии участия

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；
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Changhai hospital — Шанхай

Идентификаторы

NCT: NCT06292585 · AEDH-MT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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