NCT07258069招募中不适用
Observational, Prospective, Multicenter Study On Histoacryl Used For Embolization Of Middle Meningeal Artery (MMA) In Chronic Subdural Hematoma (CSDH) (HARMONY)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aesculap AG
- 入组人数
- 178
- 试验地点
- 7
- 主要终点
- Recurrence or progression of subdural hematoma
研究概览
简要总结
The aim of the study is to proof the effectiveness of Histoacryl® on preventing recurrence or progression of subdural hematoma after embolization of the middle meningeal artery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years old or older
- •Confirmed diagnosis of chronic subdural hematoma (CSDH) or recurrent subdural hematoma (SDH)
- •Completed documented informed consent
- •Willingness and presumed capability to participate in follow-up visits for up to 6 months (180±30 days)
排除标准
- •Extensive cerebral infarction, brain tumor, or space-occupying lesion requiring treatment
- •Need craniotomy
- •Any sign of anatomical variations that could make MMA embolization unsafe (e.g., prominent MMA-opthalmic artery anastomoses)
- •Coagulation dysfunction with INR>1.8 and/or platelet count <80x109 /L
- •Allergic reactions to essential medicines to do angiography
- •Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during the study
- •Participation in another clinical trial
结局指标
主要结局
Recurrence or progression of subdural hematoma
时间窗: within 3 months
Recurrence will be described as maximum thickness of SDH exceeding 10 mm, recurrence of symptoms or the patient requiring reoperation, meaning a second burr-hole drainage due to SDH. \*\*Progression will be described as maximum thickness of SDH increasing over 3 mm compared to the baseline.
次要结局
- Quality of life, EQ-5D-5L(V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months)
- Efficacy (1. Time)(V1, preoperatively (baseline visit))
- Quality of life, EQ-5D(V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months)
- Efficacy (2. Time)(V2, surgery (index procedure))
- Efficacy (3. Time)(6 months)
- Efficacy (4. Hematoma thickness)(at V4: 3 months and V5: 6 months compared to baseline)
- Efficacy (5. Change in midlind shift)(at V4: 3 months and V5: 6 months)
- Efficacy (6. Cognitive assessment)(V1: preoperatively, V3: discharge, V4: 3 months and V5: 6 months)
研究者
研究点 (7)
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