Management of Chronic Subdural Hematoma With or Without Embolization of Middle Meningeal Artery in Canada (EMMA-Can)- A Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Chronic Subdural Hematoma (CSDH) recurrence at 90-days on CT scan
研究概览
简要总结
EMMA-Can is a prospective randomized open-label, blinded end point (PROBE) study, that will assess the recurrence risk and safety of embolization of the middle meningeal (EMMA) when added to standard of care treatment (surgical drainage) of chronic subdural hematoma (CSDH) compared to surgical treatment alone.
详细描述
All patients in clinical need of surgical drainage for the CSDH will be randomized in our study. Patients that present in the Emergency Department (ED) or neurosurgery clinic will be assessed for standard of care treatment options based on their presenting symptoms. Patients will then by screened for study eligibility based on the study inclusion and exclusion criteria. After screening and consenting patients will be randomized in to the control arm or interventional arm.
Patients randomized to the control arm will receive institutional standard of care treatment (surgical drainage) of the CSDH.
Patients randomized to the interventional arm will receive institutional standard of care treatment (surgical drainage) of the CSDH followed by EMMA, with Onyx and under a general anesthetic within 72 hours of surgical drainage.
All patients will be followed as per the institutional standard of the care. Any peri-procedural complications and change in clinical status will be recorded. The risk of recurrence at 90-days will be assessed in all patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premorbid Modified Rankin Scale of ≤2;
- •Patients with unilateral symptomatic primary or recurrent CSDH >10 mm in thickness on CT head undergoing surgical drainage;
- •CT Angiogram of head and neck which favors vascular access for EMMA and lacks dangerous anatomic variations;
- •Patients over 18 years of age; no upper age limit.
排除标准
- •If informed consent cannot be obtained from the patients or their substitute decision makers;
- •Patients with bilateral symptomatic CSDH;
- •CTA showing persistent communication between branches of middle meningeal artery and that of internal carotid arteries;
- •Contraindication to the embolization procedure such as severe renal dysfunction (eGFR<30), or pregnancy;
- •Life expectancy < 6 months;
- •Known allergy to Onyx;
- •Acute subdural hematoma with homogenous hyperdensity on CT scan;
- •Secondary CSDH that may likely be due to the underlying condition such as a vascular lesion, brain tumor, arachnoid cyst, spontaneous intracranial hypotension or prior craniotomy;
- •Patients needing treatment with 2 weeks of dexamethasone or tranexamic acid will be contraindicated in the study patients to avoid confounding.
研究组 & 干预措施
Control Arm
Patients randomized to the control arm will undergo institutional standard of care treatment (surgical drainage) for the CSDH.
Interventional Arm
Patients randomized to the interventional arm will undergo institutional standard of care treatment (surgical drainage) for the CSDH followed by EMMA within 72 hours of surgical drainage. The embolization will be done using a liquid embolic agent (Onyx) and will be done under a general anesthesia or conscious sedation as per the operator's preference. All patients will be followed as per the institutional standard of the care. Any peri-procedural complications and change in clinical status will be recorded.
干预措施: Embolization of the Middle Meningeal Artery (Procedure)
结局指标
主要结局
Chronic Subdural Hematoma (CSDH) recurrence at 90-days on CT scan
时间窗: 90-days
Symptomatic recurrence of the CSDH on CT scan of head within 90-days from EMMA
次要结局
- Reduction of CSDH size at 90-days(90-days)
- Mortality within 90-days("up to 90-days")
- 90 day mRs ≤3(90-days)
- Reduction of CSDH size at 90-days(90-days)
- Morbidity within 90-days(" up to 90-days")
- 90-day MOCA and EQ-5D-5L health score(" Day 90")
- Discharge destination("Discharge Day")
- Length of hospital stay("Discharge Day")
研究者
Jai Shankar
Professor, Department of Radiology, Neuro-Interventional Radiologist
University of Manitoba