Back to resultsEstablishment of Regional Severe Trauma Management System
Primary Purpose
Trauma, Multiple Trauma, Emergencies
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
trauma treatment team
Basic experimental settings
Sponsored by
About this trial
This is an interventional treatment trial for Trauma focused on measuring Severe trauma, Multiple trauma, Regional Trauma management system, Trauma management team
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental group
control group
Arm Description
The trauma treatment team will be established in the experimental group
The trauma treatment team will not be established in this group，just establish the basic experimental settings
Outcomes
Primary Outcome Measures
In-hospital mortality rate
the percentage of patients who die after hospitalization for severe trauma in admitted patients with severe trauma.
Secondary Outcome Measures
Mortality rate of patients with severe trauma within 30 days after trauma attack
the 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 discharge
the percentage of patients who die within 30 days after discharge in admitted patients with severe trauma
Full Information
NCT ID
NCT03363880
First Posted
November 29, 2017
Last Updated
December 4, 2017
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03363880
Brief Title
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
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Multiple Trauma, Emergencies
Keywords
Severe trauma, Multiple trauma, Regional Trauma management system, Trauma management team
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
The trauma treatment team will be established in the experimental group
Arm Title
control group
Arm Type
Active Comparator
Arm Description
The trauma treatment team will not be established in this group，just establish the basic experimental settings
Intervention Type
Other
Intervention Name(s)
trauma treatment team
Intervention Description
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
Intervention Name(s)
Basic experimental settings
Intervention Description
Establishing the trauma management system without a trauma treatment team.
Primary Outcome Measure Information:
Title
In-hospital mortality rate
Description
the percentage of patients who die after hospitalization for severe trauma in admitted patients with severe trauma.
Time Frame
from hospital admission to discharge, an average of 20 days
Secondary Outcome Measure Information:
Title
Mortality rate of patients with severe trauma within 30 days after trauma attack
Description
the percentage of patients who die within 30 days after trauma attack in admitted patients with severe trauma
Time Frame
within 30 days after trauma attack
Title
Mortality rate of patients with severe trauma within 30 days after discharge
Description
the percentage of patients who die within 30 days after discharge in admitted patients with severe trauma
Time Frame
within 30 days after discharge
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
tianbing Wang, MD
Phone
086-010-88325911
Email
wangtianbing@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
baoguo Jiang, MD
Organizational Affiliation
Peking University People's Hospital; Peking University Traffic Medical Center; China Trauma Rescue&Treatment Association
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30518584
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.
Results Reference
derived
Learn more about this trial
Establishment of Regional Severe Trauma Management System
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