Establishment of Regional Severe Trauma Management System

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

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

Study Overview

• Status: Unknown
• Conditions: Emergencies; Trauma; Multiple Trauma
• Intervention / Treatment: Other: trauma treatment team; Other: Basic experimental settings

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 Type: Interventional
• Enrollment (Anticipated): 7250
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Wang Y, Liu HX, Wang YH, Zhang YJ, Zhang JJ, Huang W, Jiang BG, Wang TB. Establishment of trauma treatment teams within a regional severe trauma treatment system in China: study protocol for a national cluster-randomised trial. BMJ Open. 2018 Dec 4;8(12):e023347. doi: 10.1136/bmjopen-2018-023347.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: December 4, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Severe trauma; Multiple trauma; Regional Trauma management system; Trauma management team
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Wounds and Injuries; Multiple Trauma
• Other Study ID Numbers: Safe China 100 county project

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No