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Trial record 28 of 285 for:    Trauma, Nervous System | Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

Pre-and In-hospital First Aid Programs and Specifications for Spine and Spinal Cord Injury in Beijing of China

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ClinicalTrials.gov Identifier: NCT03108859
Recruitment Status : Not yet recruiting
First Posted : April 11, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Baoguo Jiang, Peking University People's Hospital

Brief Summary:
To establish a spine injury and spinal cord injury (SCI) treatment database; to complete pre- and in-hospital evaluation of spine injury and SCI, develop and optimize first aid procedures, form pre-and in-hospital standardized training program for the treatment of spine injury and SCI; to develop first aid guidelines and establish an evaluation and treatment system for early surgery, as far as possible to save the spinal cord function and reduce the degree of disability; to form expert consensus on acute SCI and "green channel" patterns, will be promoted in hospitals in Beijing and other cities of China, so as to improve the level of first aid treatment of acute spine injury and SCI in Chinese cities, and to reduce the occurrence of secondary injury and severe dysfunction due to improper treatment.

Condition or disease
Spinal Cord Injury

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pre-and In-hospital First Aid Programs and Specifications for Spine and Spinal Cord Injury in Beijing of China: a Prospective, Multicenter, Case Series Trial
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. American Spinal Injury Association impairment scale [ Time Frame: changes of week 1, month 1 and month 3 after surgery ]
    To assess spinal nerve function at postoperative 1 week, 1 and 3 months


Secondary Outcome Measures :
  1. X-ray, spine CT and MRI scans [ Time Frame: changes of week 1, month 1 and month 3 after surgery ]
    To assess spine injury and SCI and repair at preoperative, postoperative 1 week, 1 and 3 months



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Ages Eligible for Study:   16 Years to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
To recruit acute SCI patients undergoing pre-hospital treatment in the Beijing Emergency Medical Center and Beijing Red Cross Emergency Rescue Center, and receiving in-hospital treatment in the Peking University People's Hospital, Peking University Third Hospital, Beijing Friendship Hospital Affiliated to Capital Medical University, Chaoyang Hospital Affiliated to Capital Medical University, and Chinese PLA General Hospital, China.
Criteria

Inclusion Criteria:

  • Spinal cord injury patients will be evaluated as complete or incomplete (contusion) after admission using rectal examination, in accordance with American Spinal Injury Association and International Medical Society of Paraplegia (2000);
  • Final diagnosis by spine CT and/or MRI;
  • Cervical, thoracic and thoracolumbar fracture dislocation or without fracture dislocation but combined with spinal cord injury;
  • No other injury involving life, injury severity score < 16;
  • No anesthesia contraindication;
  • No local skin infection, no severe soft tissue contusion, soft tissue condition of the operation area met the operation requirements;
  • Age: 16-85 years old, irrespective of sex.

Exclusion Criteria:

  • Active or recent severe infection
  • Severe infectious diseases that need to be treated in infectious disease hospital;
  • History of mental illness;
  • History of metal allergy;
  • Long-term alcohol abuse and drug abuse;
  • Do not agree to participate in this trial; the legal representative of the patient refuses to sign informed consent;
  • Poor compliance, cannot be followed up as required.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108859


Contacts
Contact: Feng Xue, Ph.D 8618811331636 317108233@qq.com

Locations
China, Beijing
Chaoyang Hospital Affiliated to Capital Medical University Not yet recruiting
Beijing, Beijing, China, 100020
Contact: Qingjun Su, M.D.    8613911923253    qjsurex@sohu.com   
Principal Investigator: Qingjun Su, M.D.         
Beijing Friendship Hospital Affiliated to the Capital University of Medical Sciences Not yet recruiting
Beijing, Beijing, China, 100050
Contact: Baojun Wang, M.D.    8613701221290    docbjwang@126.com   
Principal Investigator: Baojun Wang, M.D.         
Peking University Third Hospital Not yet recruiting
Beijing, Beijing, China, 100191
Contact: Fang Zhou, M.D.    8613801153767    zhou.md@126.com   
Principal Investigator: Fang Zhou, M.D.         
Chinese PLA General Hospital Not yet recruiting
Beijing, Beijing, China, 100853
Contact: Tiansheng Sun, M.D.    8613501072165    suntiansheng-@163.com   
Principal Investigator: Tiansheng Sun, M.D.         
Sponsors and Collaborators
Peking University People's Hospital
Investigators
Principal Investigator: Baoguo Jiang, Ph.D Department of Orthopedics, Peking University People's Hospital, Beijing, China

Responsible Party: Baoguo Jiang, Principal Investigator, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03108859     History of Changes
Other Study ID Numbers: PekingUPH_002
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System