A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong
- Conditions
- Spinal Cord Injuries
- Registration Number
- NCT00517374
- Lead Sponsor
- China Spinal Cord Injury Network
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
General
-
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)
General
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Zhongshan Hospital
🇨🇳Shanghai, China
Tianjin Medical University Hospital
🇨🇳Tianjin, China
Chengdu Army Kuming General Hospital
🇨🇳Kunming, China
Xian Jiaotong University Second Hospital
🇨🇳Xian, China
Prince of Wales Hospital
🇨🇳Hong Kong, China
Changhai Hospital
🇨🇳Shanghai, China
Queen Mary Hospital
🇨🇳Hong Kong, China
First Affiliated Hospital of Medical College, Shantou University
🇨🇳Shantou, Guangdong, China
Beijing University People's Hospital
🇨🇳Beijing, China
Ningbo Second People Hospital
🇨🇳Ningbo, Zhejiang, China
Beijing Army General Hospital
🇨🇳Beijing, China
Beijing Xishan Hospital
🇨🇳Beijing, China
Nanfang Hospital
🇨🇳Guangzhou, China
Second Affliliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, China
China Rehabilitation Research Center
🇨🇳Beijing, China
Shanghai East Hospital
🇨🇳Shanghai, China
Xijing Hospital
🇨🇳Xian, China