A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong

Spinal Cord Injuries Clinical Trial

Official title:

A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00517374
• Other study ID #: CN100
• Status: Completed
• Phase: N/A
• First received: August 15, 2007
• Last updated: September 24, 2015
• Start date: September 2005
• Est. completion date: December 2007

Study information

• Verified date: September 2015
• Source: China Spinal Cord Injury Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics CommitteeChina: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

General

1. Male or female adult subjects, 18 to 65 years of age

2. Have a clinical diagnosis of SCI, defined by MRI

3. 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:

4. Has an acute SCI (defined as < 7 days post-injury)

Chronic SCI Study Group:

4. Has a chronic SCI (defined as > 12 months post-initial SCI surgery)

Exclusion Criteria:

General

1. Severe head injury

2. Is medically or mentally unstable according to the judgement of the Investigator

3. History of Multiple Sclerosis or peripheral demyelinating disease

4. Likely to have experimental therapy

5. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spinal Cord Injuries

Locations

Country	Name	City	State
China	Beijing Army General Hospital	Beijing
China	Beijing University People's Hospital	Beijing
China	Beijing Xishan Hospital	Beijing
China	China Rehabilitation Research Center	Beijing
China	Nanfang Hospital	Guangzhou
China	Second Affliliated Hospital of Sun Yat-sen University	Guangzhou
China	Prince of Wales Hospital	Hong Kong
China	Queen Mary Hospital	Hong Kong
China	Chengdu Army Kuming General Hospital	Kunming
China	Ningbo Second People Hospital	Ningbo	Zhejiang
China	Changhai Hospital	Shanghai
China	Shanghai East Hospital	Shanghai
China	Zhongshan Hospital	Shanghai
China	First Affiliated Hospital of Medical College, Shantou University	Shantou	Guangdong
China	Tianjin Medical University Hospital	Tianjin
China	Xian Jiaotong University Second Hospital	Xian
China	Xijing Hospital	Xian

Sponsors (2)

Lead Sponsor	Collaborator
China Spinal Cord Injury Network	The University of Hong Kong

Country where clinical trial is conducted

China,