Establishment of Regional Severe Trauma Management System

Peking University

Status: Unknown

Conditions: Emergencies; Multiple Trauma; Trauma

Treatments: Other: trauma treatment team; Other: Basic experimental settings

Study type: Interventional

Funder types: Other

Identifiers

NCT03363880

Safe China 100 county project

Details and patient eligibility

About

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

Full 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.

Enrollment: 7,250 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7,250 participants in 2 patient groups

experimental group

Experimental group

Description:

The trauma treatment team will be established in the experimental group

Treatment:

Other: trauma treatment team

control group

Active Comparator group

Description:

The trauma treatment team will not be established in this group，just establish the basic experimental settings

Treatment:

Other: Basic experimental settings