Establishment of Regional Severe Trauma Management System

Trauma Clinical Trial

Official title:

Establishment of Regional Severe Trauma Treatment System in 100 Counties: a National Multi-center, Cluster-randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03363880
• Other study ID #: Safe China 100 county project
• Status: Not yet recruiting
• Phase: N/A
• First received: November 29, 2017
• Last updated: December 4, 2017
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2017
• Source: Peking University People's Hospital
• Contact: tianbing Wang, MD
• Phone: 086-010-88325911
• Email: wangtianbing[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effects of trauma treatment team establishment on the treatment of patients with severe trauma.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 7250
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

In this study, three-level subjects (counties, hospitals, and trauma patients) will be included according to the following inclusion and exclusion criteria:

• 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.

Related Conditions & MeSH terms

• Emergencies
• Multiple Trauma
• Trauma
• Wounds and Injuries

Intervention

Other:
• trauma treatment team
Establishing the trauma management system included a trauma treatment team. The severe trauma treatment team will be composed by the physicians from departments of emergency, orthopedic trauma, urology, cardiothoracic surgery, neurosurgery, general surgery, anesthesiology, and ICU.
• Basic experimental settings
Establishing the trauma management system without a trauma treatment team.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality rate	the percentage of patients who die after hospitalization for severe trauma in admitted patients with severe trauma.	from hospital admission to discharge, an average of 20 days
Secondary	Mortality rate of patients with severe trauma within 30 days after trauma attack	the percentage of patients who die within 30 days after trauma attack in admitted patients with severe trauma	within 30 days after trauma attack
Secondary	Mortality rate of patients with severe trauma within 30 days after discharge	the percentage of patients who die within 30 days after discharge in admitted patients with severe trauma	within 30 days after discharge