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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03363880
Enrollment
7250
Registered
2017-12-06
Start date
2018-01-01
Completion date
2019-12-31
Last updated
2017-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergencies, Multiple Trauma, Trauma

Keywords

Severe trauma, Multiple trauma, Regional Trauma management system, Trauma management team

Brief summary

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

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.

Interventions

OTHERtrauma 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.

OTHERBasic experimental settings

Establishing the trauma management system without a trauma treatment team.

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion 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: *

Design outcomes

Primary

MeasureTime frameDescription
In-hospital mortality ratefrom hospital admission to discharge, an average of 20 daysthe percentage of patients who die after hospitalization for severe trauma in admitted patients with severe trauma.

Secondary

MeasureTime frameDescription
Mortality rate of patients with severe trauma within 30 days after trauma attackwithin 30 days after trauma attackthe percentage of patients who die within 30 days after trauma attack in admitted patients with severe trauma
Mortality rate of patients with severe trauma within 30 days after dischargewithin 30 days after dischargethe percentage of patients who die within 30 days after discharge in admitted patients with severe trauma

Contacts

Primary Contacttianbing Wang, MD
wangtianbing@medmail.com.cn086-010-88325911

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026