Managing Non-acute Subdural Hematoma Using Liquid Materials：a Chinese Randomized Trial of MMA Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 722
- 试验地点
- 1
- 主要终点
- Incidence of symptomatic SDH recurrence/ progression within 90 days post-procedure
研究概览
简要总结
MAGIC-MT study is multi-center, prospective, randomized (1:1) controlled trial designed to show that additional MMA embolization with Onyx in patients with non-acute symptomatic subdural hematoma(SDH) results in reduced hematoma recurrence in surgically treated patients/ reduced hematoma progression in conservatively managed patients.
详细描述
The objective of this study is to show that additional MMA embolization with Onyx in patients with non-acute symptomatic subdural hematoma(SDH) results in reduced hematoma recurrence in surgically treated patients/ reduced hematoma progression in conservatively managed 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
- •Patients with symptomatic non-acute SDH with mass effect (i.e., chronic or subacute SDH)
- •Mass effect refers to a shift in midline structure or deformation of local cerebral cortex due to SDH.
- •Symptomatic defined as neurological symptoms, such as headache, short-term cognitive dysfunction, language disorder or aphasia, gait instability, decreased muscle strength, sensory disturbances, epileptic seizure, etc.
- •Age ≥18 years;
- •Pre-morbid mRS score 2;
- •Informed Consent Form (ICF) signed by patient or guardian.
排除标准
- •Radiographic imaging indicating massive cerebral infarction with corresponding symptoms;
- •Required craniotomy or craniotomy with small bone flap to remove SDH;
- •Emergency SDH removal/drainage;
- •Bilateral SDH with unknown origin of symptoms;
- •Anatomical variations that may affect the safety of MMA embolization (e.g., prominent middle MMA-ophthalmic artery anastomosis);
- •Intractable coagulation dysfunction or abnormal platelet count and function (pre-operative International Normalized Ratio [INR] > 1.5 and/or platelet count < 80109/L);
- •Contraindications to cerebral angiography, such as allergy to iodinated contrast agents, renal insufficiency (GFR < 30 ml/min), etc.;
- •Computed tomography (CT) or magnetic resonance imaging (MRI) showing intracranial space-occupying lesions;
- •Pregnancy or planning to become pregnant;
- •Serious or fatal coexisting disease that may prevent improvement of conditions or completion of follow-up;
- •Life expectancy < 1 year;
- •Recent operation unrelated to this study or investigators believe that they will be at higher risks if antiplatelet and/or anticoagulant drugs are discontinued;
- •Inability to complete follow-up as required by the protocol;
- •Patients participating in other clinical trials;
- •Prior surgery or interventional therapy on target SDH;
- •Inability to complete MMA embolization before trepanation and drainage.
结局指标
主要结局
Incidence of symptomatic SDH recurrence/ progression within 90 days post-procedure
时间窗: 90 days
SDH recurrence (\>10 mm max. thickness) or receiving re-operation in patients who underwent surgery/ symptomatic SDH progression (\>3 mm increase in max thickness or receiving surgical rescue in patients who did not undergo sugery) at 90 days "Symptomatic" is hereby defined as one or more of the following features which are attributed to the progression/recurrence: headache, short-term cognitive decline, speech difficulty or aphasia, gait impairment, focal weakness, sensory deficits, seizures
次要结局
- Safety endpoint(30 days)
- Effectiveness(90 days and 1 year post-procedure)