Establishment of Regional Severe Trauma Management System

Sponsor
Peking University People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03363880
Collaborator
(none)
7,250
2
24

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: trauma treatment team
  • Other: Basic experimental settings
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
7250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Establishment of Regional Severe Trauma Treatment System in 100 Counties: a National Multi-center, Cluster-randomized Controlled Trial
Anticipated Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: experimental group

The trauma treatment team will be established in the experimental group

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.

Active Comparator: control group

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

Other: Basic experimental settings
Establishing the trauma management system without a trauma treatment team.

Outcome Measures

Primary Outcome Measures

  1. In-hospital mortality rate [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.

Secondary Outcome Measures

  1. Mortality rate of patients with severe trauma within 30 days after trauma attack [within 30 days after trauma attack]

    the percentage of patients who die within 30 days after trauma attack in admitted patients with severe trauma

  2. Mortality rate of patients with severe trauma within 30 days after discharge [within 30 days after discharge]

    the percentage of patients who die within 30 days after discharge in admitted patients with severe trauma

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking University People's Hospital

Investigators

  • Principal Investigator: baoguo Jiang, MD, Peking University People's Hospital; Peking University Traffic Medical Center; China Trauma Rescue&Treatment Association

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
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
ClinicalTrials.gov Identifier:
NCT03363880
Other Study ID Numbers:
  • Safe China 100 county project
First Posted:
Dec 6, 2017
Last Update Posted:
Dec 6, 2017
Last Verified:
Dec 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by 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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 6, 2017