TraumaNCT03363880
Establishment of Regional Severe Trauma Management System
A study testing trauma treatment team and Basic experimental settings in people with Trauma and Multiple Trauma, run by Peking University People's Hospital.
Trial summary
To evaluate the effects of trauma treatment team establishment on the treatment of patients with severe trauma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma, Multiple Trauma, Emergencies
- What is being tested?
- trauma treatment team and Basic experimental settings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
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- 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;
Who cannot join
- ○ 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Establishment of Regional Severe Trauma Treatment System in 100 Counties: a National Multi-center, Cluster-randomized Controlled Trial
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.
- Conditions
- Trauma, Multiple Trauma, Emergencies
- Being tested
- trauma treatment team, Basic experimental settings
- Keywords
- Severe trauma, Multiple trauma, Regional Trauma management system, Trauma management team
- Medical subject headings
- Wounds and Injuries, Multiple Trauma, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trauma treatment teamOther
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.
Basic experimental settingsOther
Establishing the trauma management system without a trauma treatment team.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The trauma treatment team will be established in the experimental group Receives: Other: trauma treatment team |
| control group | Active comparator | The trauma treatment team will not be established in this group，just establish the basic experimental settings Receives: Other: Basic experimental settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality rate
the percentage of patients who die after hospitalization for severe trauma in admitted patients with severe trauma.
Measured: from hospital admission to discharge, an average of 20 days
Secondary outcomes (2)
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
Measured: within 30 days after trauma attack
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
Measured: within 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, baoguojiang, Peking University People's Hospital
- Investigators
- baoguo Jiang, MD, Principal investigator, Peking University People's Hospital; Peking University Traffic Medical Center; China Trauma Rescue&Treatment Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363880
- Sponsor's protocol ID
- Safe China 100 county project
- Status last verified
- Dec 2017
- First submitted
- 29 Nov 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Regional Severe Trauma Treatment System in 100 Counties: a National Multi-center, Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03363880
- Acronym / sponsor ID
- Safe China 100 county project
- Conditions
- Trauma, Multiple Trauma, Emergencies
- Keywords
- Severe trauma, Multiple trauma, Regional Trauma management system, Trauma management team
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,250 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: trauma treatment teamThe trauma treatment team will be established in the experimental group |
| control group | Active comparator | Other: Basic experimental settingsThe trauma treatment team will not be established in this group，just establish the basic experimental settings |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
Key exclusion criteria (3 listed)
- ○ 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trauma treatment teamEstablishing 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. | Other | experimental group |
| Basic experimental settingsEstablishing the trauma management system without a trauma treatment team. | Other | control group |
Primary outcome
In-hospital mortality rate
Time frame: from hospital admission to discharge, an average of 20 days
the percentage of patients who die after hospitalization for severe trauma in admitted patients with severe trauma.
2 secondary outcomes
Mortality rate of patients with severe trauma within 30 days after trauma attack
Time frame: within 30 days after trauma attack
Mortality rate of patients with severe trauma within 30 days after discharge
Time frame: within 30 days after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Derived from this study: PubMed 30518584Wang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
baoguo Jiang, MD principal investigator
Peking University People's Hospital; Peking University Traffic Medical Center; China Trauma Rescue&Treatment Association
Questions about this trial
What is this clinical trial studying?
A study testing trauma treatment team and Basic experimental settings in people with Trauma and Multiple Trauma, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact tianbing Wang, MD (086-010-88325911, wangtianbing@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality rate (time frame: from hospital admission to discharge, an average of 20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03363880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.