A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 17
研究概览
简要总结
To establish a solid foundation, e.g. a network and a coordinating centre for testing new SCI therapies in forthcoming randomised controlled multi-centre clinical trials following international standards and guidelines.
详细描述
This is a multicentre, observational, registry study of outcome data on SCI patients in Mainland China and Hong Kong. The target population consists of patients who have a SCI, where acute SCI is defined as <7 days post-injury and chronic SCI is defined as >12 months post-initial SCI surgery.
A total of 600 patients (300 acute and 300 chronic) will be enrolled from 6 cities in Mainland China (namely: Beijing, Shanghai, Guangzhou, NingBo, Xi'an and Kunming) and Hong Kong. The duration of the study will be one year, with a total of 4 visits.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult subjects, 18 to 65 years of age
- •Have a clinical diagnosis of SCI, defined by MRI
- •Voluntarily signs and dates an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures
- •Acute SCI Study Group:
- •Has an acute SCI (defined as < 7 days post-injury)
- •Chronic SCI Study Group:
- •Has a chronic SCI (defined as > 12 months post-initial SCI surgery)
排除标准
- •Severe head injury
- •Is medically or mentally unstable according to the judgement of the Investigator
- •History of Multiple Sclerosis or peripheral demyelinating disease
- •Likely to have experimental therapy
- •Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol