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临床试验/NCT03108859
NCT03108859Unknown不适用

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

Peking University People's Hospital4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
4
主要终点
American Spinal Injury Association impairment scale

研究概览

简要总结

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.

详细描述

This is a prospective, multicenter, non-randomized controlled trial. The target population consists of 200 acute spinal cord injury 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.

History and current related studies Acute spinal cord injury (SCI) as a clinical common disease is the difficulty of clinical treatment, and frequently occurs in young adults. The incidence of acute SCI is 30-40/million people in Europe and USA, but 60.2/million people in Beijing of China. The complete SCI is very dangerous, and there is no effective medical therapy. At present, the effective treatment of acute SCI should be the first aid and advanced rehabilitation.

24 hours is the best time to rescue spinal cord function after SCI, especially 3-8 hours after injury is the golden opportunity. A large dose of hormone therapy in the 3-8 hours after injury can reduce secondary injury, thereby reducing the degree of SCI. 24 hours after injury, early surgery for relieving spinal cord compression can significantly improve the recovery of spinal cord function. Timely and properly pre-hospital first aid, quick hospital admissions and assessment, and timely surgery are essential for the rescue of spinal cord function. Patients with incomplete SCI can be completely injured and lose the possibility of recovery of spinal cord function due to improper first aid or untimely treatment. Complete SCI will cause more severe injury due to improper treatment. It may be difficult to make up for surgery or rehabilitation training. A sound and rapid treatment system is the basis for improving the treatment level of SCI, but we still lack of this kind of system in China.

In Beijing of China, pre-hospital treatment can be done by Beijing Emergency Medical Center (120 first aid system) and Beijing Red Cross Hospital (999 first aid system). While cooperating with each other, it is also faced with different mechanisms, different treatment patterns and overlapping treatment regions. As for the in-hospital treatment, Beijing has a large number of high-level hospitals, but these hospitals are overcrowding. There is no SCI treatment specialist or professional hospital in Beijing City, so treatment basically relies on various general hospitals. In pre-hospital first aid and in-hospital treatment of Beijing City, the medical information transfer is not smooth; the treatment process is separated, and it lacks of standardized treatment. The ability and level of medical personnels are not consistent, the technology is backward, and there is lack of professional training. Thus, the vast majority of patients with SCI cannot be treated within the optimal treatment time after injury. It is also an important cause of higher mortality and disability in SCI patients in China compared with the developed countries.

In 2006, Professor Bao-guo Jiang, director of the Department of Orthopedics, Peking University People's Hospital, led the establishment of the Traffic Medicine Center of Peking University, involving Peking University People's Hospital, School of Public Health of Peking University, Peking University First Hospital, Peking University Third Hospital, Beijing Traffic Management Bureau, and Beijing Emergency Medical Center in China. Reviewed by the Health and Family Planning Commission, the "National Center for Severe Trauma Training" was set up in 2015, and Bao-guo Jiang served as the director of the center. The Traffic Medicine Center and two emergency centers in Beijing have cooperated for many years, and established an epidemiological database for the treatment of severe trauma and the linkage mechanism of pre-hospital and in-hospital. The treatment of spine injury and SCI is one of important contents for treating severe trauma. With this center as a platform, the database of SCI patients can be specialized; a unified standardized and rapid treatment can be carried out in many participating medical units using the linkage mechanism with the emergency centers; a high level of scientific research can be carried out, and a series of studies can be started, concerning SCI epidemiology, treatment procedures and improvement in treatment effect. Simultaneously, the standardized training for pre-hospital and in-hospital first aid care personnel in each research center and hospital can be completed.

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
16 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

结局指标

主要结局

American Spinal Injury Association impairment scale

时间窗: changes of week 1, month 1 and month 3 after surgery

To assess spinal nerve function at postoperative 1 week, 1 and 3 months

次要结局

  • X-ray, spine CT and MRI scans(changes of week 1, month 1 and month 3 after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Baoguo Jiang

Principal Investigator

Peking University People's Hospital

研究点 (4)

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