Establishment of Regional Severe Trauma Management System

NCT03363880 | Unknown DMC

• 1 other identifier: Safe China 100 county project
• Study Type: interventional
• Target: 7,250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Trauma; Multiple Trauma; Emergencies

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mortality rate of patients with severe trauma within 30 days after trauma attack

  within 30 days after trauma attack

• Mortality rate of patients with severe trauma within 30 days after discharge

  within 30 days after discharge

Study Arms (2)

experimental group

EXPERIMENTAL

The trauma treatment team will be established in the experimental group

Other: trauma treatment team

control group

ACTIVE COMPARATOR

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

Other: Basic experimental settings

Interventions

trauma treatment team OTHER

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.

experimental group

Basic experimental settings OTHER

Establishing the trauma management system without a trauma treatment team.

control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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;
• 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;
• 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;
• ○ All second-grade class A or third-grade class A hospitals in the county cannot establish a trauma treatment team because of various reasons;
• ○ Hospitals can not establish a trauma treatment team because of various reasons;
• Patients with trauma from regions not included in this study.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Related Publications (1)

• 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.

  PMID: 30518584 DERIVED

MeSH Terms

Conditions

Wounds and Injuries; Multiple Trauma; Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• baoguo Jiang, MD

  Peking University People's Hospital; Peking University Traffic Medical Center; China Trauma Rescue&Treatment Association

  PRINCIPAL INVESTIGATOR

Central Study Contacts

tianbing Wang, MD

CONTACT

086-010-88325911; wangtianbing@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Peking University People's Hospital, Director of department of orthopaedic surgery of Peking University, Chairman of China trauma rescue&treatment association

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 6, 2017
• Study Start: January 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 6, 2017

Record last verified: 2017-12