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

NCT ID: NCT00517374

Last Updated: 2015-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role collaborator

China Spinal Cord Injury Network

NETWORK

Sponsor Role lead

Responsible Party

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Clinical Trial Centre, The University of Hong Kong

Principal Investigators

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Wise Young, MD, PhD

Role: STUDY_DIRECTOR

Unaffilated

Locations

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First Affiliated Hospital of Medical College, Shantou University

Shantou, Guangdong, China

Site Status

Ningbo Second People Hospital

Ningbo, Zhejiang, China

Site Status

Beijing Army General Hospital

Beijing, , China

Site Status

Beijing University People's Hospital

Beijing, , China

Site Status

Beijing Xishan Hospital

Beijing, , China

Site Status

China Rehabilitation Research Center

Beijing, , China

Site Status

Nanfang Hospital

Guangzhou, , China

Site Status

Second Affliliated Hospital of Sun Yat-sen University

Guangzhou, , China

Site Status

Prince of Wales Hospital

Hong Kong, , China

Site Status

Queen Mary Hospital

Hong Kong, , China

Site Status

Chengdu Army Kuming General Hospital

Kunming, , China

Site Status

Changhai Hospital

Shanghai, , China

Site Status

Shanghai East Hospital

Shanghai, , China

Site Status

Zhongshan Hospital

Shanghai, , China

Site Status

Tianjin Medical University Hospital

Tianjin, , China

Site Status

Xian Jiaotong University Second Hospital

Xi'an, , China

Site Status

Xijing Hospital

Xi'an, , China

Site Status

Countries

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China

Other Identifiers

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CN100

Identifier Type: -

Identifier Source: org_study_id

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