Clinical trial NCT03363880: Establishment of Regional Severe Trauma Management System
Official title: Establishment of Regional Severe Trauma Treatment System in 100 Counties: a National Multi-center, Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trauma
Multiple Trauma
Emergencies
Keywords: Severe trauma
Multiple trauma
Regional Trauma management system
Trauma management team
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 7250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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:
* 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.

Primary outcomes:
measure: In-hospital mortality rate
timeFrame: from hospital admission to discharge, an average of 20 days
Secondary outcomes:
measure: Mortality rate of patients with severe trauma within 30 days after trauma attack
timeFrame: within 30 days after trauma attack
measure: Mortality rate of patients with severe trauma within 30 days after discharge
timeFrame: within 30 days after discharge
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital; Peking University Traffic Medical Center; China Trauma Rescue&Treatment Association
name: baoguo Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.