Establishment of Regional Severe Trauma Treatment System in 100 Counties: a National Multi-center, Cluster-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 7,250
- 主要终点
- In-hospital mortality rate
研究概览
简要总结
To evaluate the effects of trauma treatment team establishment on the treatment of patients with severe trauma.
详细描述
This is a national multi-center, cluster-randomized controlled trial. This cluster-randomized controlled trial will be performed, with counties as the randomization units. The included counties will be randomized into an experimental group and a control group. A trauma treatment team will be only established in the experimental group. The in-hospital mortality rate will be compared between the experimental and control groups to investigate the effects of trauma treatment team establishment on the treatment of patients with severe trauma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In this study, three-level subjects (counties, hospitals, and trauma patients) will be included according to the following inclusion and
排除标准
- •inclusion:
- •Inclusion criteria of counties:
- •National counties and county-level administrative regions;
- •Local government and health management department have the desire and requirements to establish a standardized trauma emergency treatment system;
- •More than 500,000 people;
- •With pre-hospital emergency treatment system;
- •Trauma first aid needs: No less than 20 patients with severe trauma (ISS ≥ 16) throughout the county;
- •Inclusion criteria of hospitals:
- •With the most advanced regional treatment resources during the entire period from trauma recovery to rehabilitation for third-grade class A hospitals;
- •With basic trauma treatment resources for second-grade class A hospitals;
- •Trauma doctors are on call 24 hours a day and can participate in the early treatment of patients with trauma;
- •Inclusion criteria of patients:
- •Patients with acute trauma occurring within 48 hours;
- •Patients are transferred to trauma treatment center hospital or trauma treatment non-center hospitals;
- •Patients themselves go to or are transferred by their family members to the trauma treatment center hospital or trauma treatment non-center hospita;
- •Exclusion:
- •Exclusion criteria of counties:
- •○ All second-grade class A or third-grade class A hospitals in the county cannot establish a trauma treatment team because of various reasons;
- •Exclusion criteria of hospitals:
- •○ Hospitals can not establish a trauma treatment team because of various reasons;
- •Exclusion criteria of patients:
- •Patients with trauma from regions not included in this study.
研究组 & 干预措施
experimental group
The trauma treatment team will be established in the experimental group
干预措施: trauma treatment team (Other)
control group
The trauma treatment team will not be established in this group，just establish the basic experimental settings
干预措施: Basic experimental settings (Other)
结局指标
主要结局
In-hospital mortality rate
时间窗: from hospital admission to discharge, an average of 20 days
the percentage of patients who die after hospitalization for severe trauma in admitted patients with severe trauma.
次要结局
- Mortality rate of patients with severe trauma within 30 days after trauma attack(within 30 days after trauma attack)
- Mortality rate of patients with severe trauma within 30 days after discharge(within 30 days after discharge)
研究者
baoguojiang
Dean of Peking University People's Hospital, Director of department of orthopaedic surgery of Peking University, Chairman of China trauma rescue&treatment association
Peking University People's Hospital