ClinicalTrials.gg
Status unknownNCT03363880Updated Dec 6, 2017

Establishment of Regional Severe Trauma Management System

An interventional study of trauma treatment team and Basic experimental settings in Trauma, Multiple Trauma and Emergencies, sponsored by Peking University People's Hospital. Status unknown. Per ClinicalTrials.gov, last updated 2017-12-06.

Primary conditionMultiple TraumaRegistry: Wounds and InjuriesReclassifiedWhy we changed it
Registry
Wounds and Injuries — the first condition term the registry derived for this study.
ClinicalTrials.gg
Multiple Trauma
Why
  1. The study's listed conditions name Multiple Trauma, a narrower term within Wounds and Injuries.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
7,250
Allocation
Randomized
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Trauma
  • Multiple Trauma
  • Emergencies

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Keywords

  • Severe trauma
  • Multiple trauma
  • Regional Trauma management system
  • Trauma management team
03

In context

Multiple Trauma Reclassified

139 studies on the registry are indexed under Multiple Trauma; 32 are open to participants now.

This study's planned enrollment of 7,250 is above the median of 94 across 50 interventional studies indexed under Multiple Trauma.

Browse Multiple Trauma studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 609 studies on the registry; 247 are open to participants now.

Compared within Multiple Trauma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Wounds and Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
7,250 participants (estimated)

Study arms

  • Experimental
    experimental group

    The trauma treatment team will be established in the experimental group

    Other: trauma treatment team

  • Active comparator
    control group

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

    Other: Basic experimental settings

Interventions

  • Othertrauma 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.

  • OtherBasic experimental settings

    Establishing the trauma management system without a trauma treatment team.

06

What researchers measure

Primary outcomes

  1. In-hospital mortality rate

    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 outcomes

  1. 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

    Time frame: within 30 days after trauma attack

  2. 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

    Time frame: within 30 days after discharge

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 30518584 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03363880
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, Peking University People's Hospital) — Principal investigator
First posted
Dec 6, 2017
Start date
Jan 1, 2018 (estimated)
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Dec 6, 2017

Study contacts

tianbing Wang, MD
Contact
wangtianbing@medmail.com.cn
086-010-88325911
baoguo Jiang, MD
principal investigator · Peking University People's Hospital; Peking University Traffic Medical Center; China Trauma Rescue&Treatment Association

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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