Establishment of Regional Severe Trauma Management System

NCT ID: NCT03363880

Last Updated: 2017-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 7250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-12-31

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.

Conditions

Trauma; Multiple Trauma; Emergencies

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

The trauma treatment team will be established in the experimental group

Group Type: EXPERIMENTAL

trauma treatment team

Intervention Type: 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.

control group

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

Group Type: ACTIVE_COMPARATOR

Basic experimental settings

Intervention Type: OTHER

Establishing the trauma management system without a trauma treatment team.

Interventions

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.

Intervention Type: OTHER

Basic experimental settings

Establishing the trauma management system without a trauma treatment team.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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;
• Exclusion:

Exclusion Criteria

• inclusion:

○ 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

baoguo Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

tianbing Wang, MD

Role: CONTACT

Phone: 086-010-88325911

Email: wangtianbing@medmail.com.cn

References

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.

Reference Type: DERIVED

PMID: 30518584 (View on PubMed)

Other Identifiers

Safe China 100 county project

Identifier Type: -

Identifier Source: org_study_id