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临床试验/NCT04170582
NCT04170582招募中不适用

Patient Registry for Patients With Chronic Subdural Hematoma

Heinrich-Heine University, Duesseldorf1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
250
试验地点
1
主要终点
National Institut of Health Stroke Scale

研究概览

简要总结

All admitted patients diagnosed with unilateral or bilateral chronic subdural hematoma are included into this registry after consent. Clinical condition, radiological details, therapy (intervention/medication treatment/conservative) and outcome are documented. Patient follow-up is documented over at least 24 month with focus on neurological condition (NIHSS), cognitive impairment (MoCA) and quality of life (SF-12 ver. 2).

详细描述

Chronic subdural hematoma (cSDH) is a frequent disease in- predominantly - elderly patients often caused by minor trauma to the bridging veins eventually leading to a collection of old blood in the subdural space over time. Besides age of the patients a number of further risk factors are assumed to favor pathogenesis. Depending on size and location of blood collections diverse neurological symptoms can be seen. Therapy approaches are heterogeneous ranging from conservative treatment with or without medication to surgical treatment. There also is lacking knowledge regarding neurocognitive impairment and effects on quality of life in patients under different therapy regimes.

The prospective patient registry will enclose all patients admitted to the investigator's department diagnosed with cSDH either by MRI or CT scan after informed consent. Medical history, regular medication, social status, radiological findings and neurological examination using NIHSS will be performed at time of inclusion, discharge and follow-up. Additionally, neurocognitive testing and documentation of Quality of Life using MOCA Test and SF-12 will be conducted at different timepoints. Moreover a detailed documentation of therapy strategies is implemented in the study protocol.

With this registry the study group expects to obtain significant data leading to a more standardized and optimized therapy regime and furthermore widening understanding on so far rarely known impact of cSDH on neurocognition and quality of life.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • unilateral or bilateral chronic subdural hematoma
  • patient consent

排除标准

  • acute subdural hematoma
  • no patient consent
  • subdural hygroma

结局指标

主要结局

National Institut of Health Stroke Scale

时间窗: 24 Month

Neurological condition as measured by NIHSS: This tool is used to objectively quantify neurological impairment. The score is composed of 11 items each scoring one specific ability with values between 0 and 4 points. A higher score indicates a higher level of impairment. The maximum score is 42, the minimum scor is 0 indicating no neurological impairment.

次要结局

  • Montreal Cognitive Assessment(24 month)
  • Short Form 12 ver. 2(24 month)

研究者

发起方
Heinrich-Heine University, Duesseldorf
申办方类型
Other
责任方
Sponsor

研究点 (1)

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