NCT06772740招募中不适用
Randomized Clinical Trial of Middle Meningeal Artery Embolization for Patients With Chronic Subdural Hematoma (COMPLEMENT Study)
Kazutaka Uchida1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年12月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Rate of recurrence of chronic subdural hematoma
研究概览
简要总结
COMPLEMENT study (ChrOnic subdural hematoMa Patients suppLemented with Embolization of Middle mENingeal artery Trial) is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to assess the efficacy and safety of middle meningeal artery embolization for chronic subdural hematoma.
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
- •pre-mRS 0-3
- •Hematoma thickness >=10mm
- •Having at least one risk factor Risk factor: Age >=75, Antithrombotic therapy, DM, Bilateral hematoma, Markwalder grading score >3, Preoperative volume >=130ml, Preoperative midline shift >=8mm, CT appearance (Homogeneous, laminar or separated)
排除标准
- •Plt <50,000, PT-INR >2
- •Life expectancy <6 months
研究组 & 干预措施
Conventional treatments with middle meningeal artery embolization
Experimental
干预措施: Middle meningeal artery embolization (Procedure)
Conventional treatments alone
No Intervention
结局指标
主要结局
Rate of recurrence of chronic subdural hematoma
时间窗: 6 months after randomization
Recurrence of chronic subdural hematoma is defined as the maximum thickness of subdural hematoma exceeding 10 mm or the patient receiving re-operation.
次要结局
未报告次要终点
研究者
Kazutaka Uchida
Associate Professor (Stroke Center)
Hyogo Medical University
研究点 (1)
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