TraumaNCT05799170
Evaluation of the Effectiveness of a Regional Trauma Care System for the Treatment of Patients With Severe Trauma
A study testing regional trauma care in people with Trauma, run by Peking University People's Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Trauma
- What is being tested?
- regional trauma care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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. -
About this study
Official title: Evaluation of the Effectiveness of a Regional Trauma Care System for the Treatment of Patients With Severe Trauma: Protocol for a Prospective, Multicenter, Stepped-wedge Cluster-randomized Controlled Clinical Trial
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.
Read the detailed description
Background: 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.
Methods: This study is a prospective, multicenter, stepped-wedge cluster-randomized controlled clinical trial. Twenty hospitals are selected based on specific eligibility criteria. After the baseline period, 5 randomization steps with 4 hospitals per step will be conducted. Each hospital will gradually enter intervention period in the randomized order for the implementation of regional trauma care system. The initial 1-month is considered as the intervention transition period, during which hospitals are modified and healthcare workers are trained according to the requirements of the regional trauma care system.
Conclusion: This is the first study assessing the effectiveness of the regional trauma care system on the treatment of patients with severe trauma with the conduction a prospective study in China.
- Conditions
- Trauma
- Being tested
- regional trauma care
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional trauma careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: regional trauma care |
| usual care | No intervention | usual care/standard of care no intervention implemented |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Oct 2023 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feifei Jin, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799170
- Sponsor's protocol ID
- RT study
- Status last verified
- Apr 2023
- First submitted
- 9 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Regional Trauma Care System for the Treatment of Patients With Severe Trauma: Protocol for a Prospective, Multicenter, Stepped-wedge Cluster-randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05799170
- Acronym / sponsor ID
- RT study
- Conditions
- Trauma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Apr 2023 (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.
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.
Detailed description
Background: 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.
Methods: This study is a prospective, multicenter, stepped-wedge cluster-randomized controlled clinical trial. Twenty hospitals are selected based on specific eligibility criteria. After the baseline period, 5 randomization steps with 4 hospitals per step will be conducted. Each hospital will gradually enter intervention period in the randomized order for the implementation of regional trauma care system. The initial 1-month is considered as the intervention transition period, during which hospitals are modified and healthcare workers are trained according to the requirements of the regional trauma care system.
Conclusion: This is the first study assessing the effectiveness of the regional trauma care system on the treatment of patients with severe trauma with the conduction a prospective study in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: regional trauma careStudy 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. |
| usual care | No intervention | –usual care/standard of care no intervention implemented |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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. -
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 |
|---|---|---|
| regional trauma careStudy 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. | Other | intervention |
Primary outcome
the mortality of patients with severe trauma
Time frame: one week
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing regional trauma care in people with 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 3 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: opening soon, as of the sponsor's last update on 5 Apr 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the mortality of patients with severe trauma (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2023.