Evaluation of the Effectiveness of a Regional Trauma Care System for the Treatment of Patients With Severe Trauma

NCT05799170 | Not Yet Recruiting

• 1 other identifier: RT study
• Study Type: interventional
• Target: 3,200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Severe trauma imposes a heavy burden to society and family because of its high mortality and disability rate. Based on the implementation plan of "one region", "two links", and "three teams", the Trauma Medicine Center of Peking University People's Hospital has constructed regional trauma care system that is suitable for China's national conditions. The primary objective of this trial is to evaluate the effectiveness of the regional trauma care system on the treatment of patients with severe trauma in China.This study is a prospective, multicenter, stepped-wedge cluster-randomized controlled clinical trial.

Conditions

Trauma

Outcome Measures

Primary Outcomes (1)

• the mortality of patients with severe trauma

  The primary efficacy indicator is the mortality of patients with severe trauma at one week after trauma treatment. Mortality is defined as the percentage of patients with severe trauma who die after trauma treatment to the total number of patients with severe trauma receiving treatment.

  one week

Study Arms (2)

intervention

EXPERIMENTAL

Study intervention is the establishment of in-hospital trauma treatment centers and the formation of regional trauma care system. Regional trauma care system refers to both the establishment of unified and standardized pre-hospital and in-hospital trauma triage and injury classification warning mechanism and the development of unified trauma treatment process and standard in a main government district (population within 1 million), with secondary general hospitals and above that have strong treatment capability as the trauma treatment centers. Regional trauma care system will strengthen both pre-hospital emergency care and in-hospital emergency treatment while reinforcing the information exchange between in-hospital emergency treatment and specialized treatment.

Other: regional trauma care

usual care

NO INTERVENTION

usual care/standard of care no intervention implemented

Interventions

regional trauma care OTHER

Study intervention is the establishment of in-hospital trauma treatment centers and the formation of regional trauma care system. Regional trauma care system refers to both the establishment of unified and standardized pre-hospital and in-hospital trauma triage and injury classification warning mechanism and the development of unified trauma treatment process and standard in a main government district (population within 1 million), with secondary general hospitals and above that have strong treatment capability as the trauma treatment centers. Regional trauma care system will strengthen both pre-hospital emergency care and in-hospital emergency treatment while reinforcing the information exchange between in-hospital emergency treatment and specialized treatment. Taking 5 to 6 hospitals with certain trauma treatment capacity as the trauma treatment point, the trauma treatment network is formed relying on the treatment point hospitals within the range of one trauma treatment center.

intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age of 18-60 years old, with no restriction on gender;
• Severe trauma, including trauma patients with ISS score ≥ 16;
• Time from trauma to admission \<24h.

You may not qualify if:

• Patients who complicated with underlying diseases, such as malignant tumor and diabetes mellitus;
• Patients with important organ dysfunction before trauma;
• The investigator considers not appropriate for enrollment. -

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: April 5, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share