Registry of Chronic Subdural Hematoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- modified Rankin Scale (mRS) score at 3 months following diagnosis
研究概览
简要总结
The goal of this observational study is to better understand how chronic subdural hematoma (CSDH) progresses and how patients are treated and cared for. The study focuses on three main questions:
- What are the characteristics of patients with CSDH when they are diagnosed?
- What treatments do patients with CSDH receive?
- What are the outcomes for patients with CSDH, including their functional ability, cognitive health, and neurological status?
Participants will receive their usual standard treatment. As part of the study, they will complete a brief telephone interview three months after their treatment.
详细描述
Rationale:
Chronic subdural hematoma (CSDH) is a common condition encountered by neurologists and neurosurgeons. While guidelines for the management of CSDH have recently been developed, high-quality evidence to inform these recommendations, particularly level I evidence from randomized clinical trials (RCTs), is awaited. Significant variability in the management of CSDH persists at international, national, and inter-hospital levels. To further refine and implement evidence-based guidelines, a detailed understanding of current clinical practices and their associated outcomes is essential.
Objective:
To describe the baseline characteristics, treatment strategies, and outcomes of patients diagnosed with chronic subdural hematoma.
Study design:
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
- •Patients diagnosed with CSDH
- •18 years or older
排除标准
- •Patients who do not consent to participate in the registry
结局指标
主要结局
modified Rankin Scale (mRS) score at 3 months following diagnosis
时间窗: 3 months following diagnosis
Functional outcome assessed using the modified Rankin Scale (mRS), a 6-point scale where 0 indicates no symptoms, higher scores reflect greater disability, and 6 represents death.
次要结局
- Recurrence rate within 3 months following diagnosis(3 months following diagnosis)
- Mortality within 3 months following diagnosis(3 months following diagnosis)
- Complications within 3 months following diagnosis(3 months following diagnosis)
- Duration of hospital stay(3 months following diagnosis)
- Markwalder Grading Scale (MGS) score at 3 months following diagnosis(3 months following diagnosis)
- modified National Institutes of Health Stroke Scale (mNIHSS) score at 3 months following diagnosis(3 months following diagnosis)
- Telephone Interview for Cognitive Status (TICS) score at 3 months following diagnosis(3 months following diagnosis)
研究者
R. Dammers
Principal Investigator
Erasmus Medical Center