Multiple Trauma/InjuriesNCT03791333
A Multi-center Clinical Study on the Status of Trauma Evaluating Ability in Patients With Multiple Trauma
An observational study of Multiple Trauma/Injuries, run by Peking University People's Hospital.
Trial summary
Trauma is a major medical and public health problem facing all countries in the world today. Trauma is the leading cause of death worldwide for people under 45 years of age, and more than 5 million people die each year from severe trauma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Trauma/Injuries
- What is being tested?
- injury severity score
- How many people
- 3,600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 31 Dec 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with multiple injuries who visited our research centers
Who may be able to join
- 1.Age not less than 18 years old; 2. Multiple trauma patients; 3. Complete auxiliary examination data of various trauma sites.
Who cannot join
- Patients who died on the spot or came to hospital; pregnant and lying-in women.
Trial locations and contacts
No sites are listed yet.
About this study
Trauma is a major medical and public health problem facing all countries in the world today. Trauma is the leading cause of death worldwide for people under 45 years of age, and more than 5 million people die each year from severe trauma. According to the "China Injury Prevention Report" issued by the Ministry of Health in August 2007, about 200 million injuries occur annually in China, with 700,000 to 750,000 deaths, accounting for about 9% of the total number of deaths. Serious trauma has the characteristics of high mortality and disability rate, and often affects the main groups of young and middle-aged people of social labor force. It has a tremendous impact on social and economic development, and has brought a heavy burden to society and families. The treatment of severe trauma is extremely important, and its treatment process needs a standardized model. In many links of trauma treatment, accurate assessment of injury is the precondition of classification and grading of diagnosis and treatment, and also provides a good basis for the follow-up standardized treatment of patients. The accuracy and consistency of injury assessment are also the reflection of diagnosis and treatment ability. ISS score is an evaluation method for severe trauma and multiple trauma patients. It has been used by emergency personnel for a long time. It also plays a very good auxiliary role in the evaluation and treatment of patients'injuries. However, there are still many problems in the clinical use of ISS scores: 1. Some hospitals do not attach importance to the application of ISS scores, and do not fully understand the scoring method; 2. Low frequency of use, inaccurate grasp of the method; 3. Three-level physicians have different valuations of ISS scores for the same kind of trauma; 4. Use AIS scoring table to calculate. It takes a long time to calculate the ISS score, which affects the normal first aid efficiency. To this end, our research team designed a questionnaire on the use of ISS score. The main purpose of the questionnaire is to assess and register the severity of injury in multiple trauma patients to understand the current use and proficiency of ISS score system by Chinese trauma surgeons, the difference of ISS score between three-level doctors and the same patient, and ISS score. The consistency between the software and AIS scoring table and the scoring time of the two methods are also discussed. This study hopes that through this survey, we can understand the current situation of the application of the scoring system in Chinese hospitals, in order to promote the standardization of severe trauma assessment and promote the use of the evaluation system in hospitals throughout the country, so as to provide optimized trauma treatment process for trauma patients.
Read the detailed description
- Research Background and Basis for Project Establishment* Trauma is a major medical and public health problem facing all countries in the world today. Trauma is the leading cause of death worldwide for people under 45 years of age, and more than 5 million people die each year from severe trauma. According to the "China Injury Prevention Report" issued by the Ministry of Health in August 2007, about 200 million injuries occur annually in China, with 700,000 to 750,000 deaths, accounting for about 9% of the total number of deaths. Serious trauma has the characteristics of high mortality and disability rate, and often affects the main groups of young and middle-aged people of social labor force. It has a tremendous impact on social and economic development, and has brought a heavy burden to society and families. The treatment of severe trauma is extremely important, and its treatment process needs a standardized model. In many links of trauma treatment, accurate assessment of injury is the precondition of classification and grading of diagnosis and treatment, and also provides a good basis for the follow-up standardized treatment of patients. The accuracy and consistency of injury assessment are also the reflection of diagnosis and treatment ability. ISS score is an evaluation method for severe trauma and multiple trauma patients. It has been used by emergency personnel for a long time. It also plays a very good auxiliary role in the evaluation and treatment of patients'injuries. However, there are still many problems in the assessment of severe trauma in various parts of China. It is difficult to adapt to the needs of the current medical and health system reform and to meet the needs of the society for the assessment of severe trauma. In the clinical use of ISS scoring, the main problems are as follows: 1. Some hospitals do not attach importance to the application of ISS scoring, and do not fully understand the scoring method; 2. The use of low frequency, inaccurate grasp of the method; 3. Three-level physicians have different evaluation of ISS scoring for the same kind of trauma; 4. Applying AIS scoring table to calculate ISS scoring. It takes a long time to share the time, which affects the normal first aid efficiency.
- Research purposes * By assessing and registering the severity of multiple trauma patients, we can understand and improve the ability of different hospitals and doctors at different levels in different regions to assess the severity of multiple trauma patients, and promote the use of ISS scoring system in national trauma centers. In order to improve the level of understanding of multiple trauma patients and lay a foundation for the establishment of scientific classification and sorting and treatment system.
- Conditions
- Multiple Trauma/Injuries
- Being tested
- injury severity score
- Medical subject headings
- Multiple Trauma, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injury severity scoreOther
injury severity score of multi trauma patients
| Study group | Role | What they receive |
|---|---|---|
| multi trauma patients group | Not described Receives: Other: injury severity score |
What is being measured
The primary outcome is the main question the study is designed to answer.
ISS score of third-level surgeons for the same patient
ISS score of third-level surgeons for the same patient
Measured: 3 years
Scoring time
Scoring spending time
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start1 Jan 2019 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple Trauma/InjuriesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang tianbing, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03791333
- Sponsor's protocol ID
- PUPH20181127
- Status last verified
- Dec 2018
- First submitted
- 31 Dec 2018
- Last updated
- 2 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kirkpatrick JR, Youmans RL. Trauma index. An aide in the evaluation of injury victims. J Trauma. 1971 Aug;11(8):711-4. No abstract available.
PubMed 5565650Koehler JJ, Baer LJ, Malafa SA, Meindertsma MS, Navitskas NR, Huizenga JE. Prehospital Index: a scoring system for field triage of trauma victims. Ann Emerg Med. 1986 Feb;15(2):178-82. doi: 10.1016/s0196-0644(86)80016-6.
PubMed 3946860Jennett B. The Glasgow Coma Scale: History and current practice. Trauma, 2002, 4(2):91-103.
Baker SP, O'Neill B, Haddon W Jr, Long WB. The injury severity score: a method for describing patients with multiple injuries and evaluating emergency care. J Trauma. 1974 Mar;14(3):187-96. No abstract available.
PubMed 4814394
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Clinical Study on the Status of Trauma Evaluating Ability in Patients With Multiple Trauma
- ClinicalTrials.gov ID
- NCT03791333
- Acronym / sponsor ID
- PUPH20181127
- Conditions
- Multiple Trauma/Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 2 Jan 2019 (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.
Trauma is a major medical and public health problem facing all countries in the world today. Trauma is the leading cause of death worldwide for people under 45 years of age, and more than 5 million people die each year from severe trauma. According to the "China Injury Prevention Report" issued by the Ministry of Health in August 2007, about 200 million injuries occur annually in China, with 700,000 to 750,000 deaths, accounting for about 9% of the total number of deaths. Serious trauma has the characteristics of high mortality and disability rate, and often affects the main groups of young and middle-aged people of social labor force. It has a tremendous impact on social and economic development, and has brought a heavy burden to society and families. The treatment of severe trauma is extremely important, and its treatment process needs a standardized model. In many links of trauma treatment, accurate assessment of injury is the precondition of classification and grading of diagnosis and treatment, and also provides a good basis for the follow-up standardized treatment of patients. The accuracy and consistency of injury assessment are also the reflection of diagnosis and treatment ability. ISS score is an evaluation method for severe trauma and multiple trauma patients. It has been used by emergency personnel for a long time. It also plays a very good auxiliary role in the evaluation and treatment of patients'injuries. However, there are still many problems in the clinical use of ISS scores: 1. Some hospitals do not attach importance to the application of ISS scores, and do not fully understand the scoring method; 2. Low frequency of use, inaccurate grasp of the method; 3. Three-level physicians have different valuations of ISS scores for the same kind of trauma; 4. Use AIS scoring table to calculate. It takes a long time to calculate the ISS score, which affects the normal first aid efficiency. To this end, our research team designed a questionnaire on the use of ISS score. The main purpose of the questionnaire is to assess and register the severity of injury in multiple trauma patients to understand the current use and proficiency of ISS score system by Chinese trauma surgeons, the difference of ISS score between three-level doctors and the same patient, and ISS score. The consistency between the software and AIS scoring table and the scoring time of the two methods are also discussed. This study hopes that through this survey, we can understand the current situation of the application of the scoring system in Chinese hospitals, in order to promote the standardization of severe trauma assessment and promote the use of the evaluation system in hospitals throughout the country, so as to provide optimized trauma treatment process for trauma patients.
Detailed description
- Research Background and Basis for Project Establishment* Trauma is a major medical and public health problem facing all countries in the world today. Trauma is the leading cause of death worldwide for people under 45 years of age, and more than 5 million people die each year from severe trauma. According to the "China Injury Prevention Report" issued by the Ministry of Health in August 2007, about 200 million injuries occur annually in China, with 700,000 to 750,000 deaths, accounting for about 9% of the total number of deaths. Serious trauma has the characteristics of high mortality and disability rate, and often affects the main groups of young and middle-aged people of social labor force. It has a tremendous impact on social and economic development, and has brought a heavy burden to society and families. The treatment of severe trauma is extremely important, and its treatment process needs a standardized model. In many links of trauma treatment, accurate assessment of injury is the precondition of classification and grading of diagnosis and treatment, and also provides a good basis for the follow-up standardized treatment of patients. The accuracy and consistency of injury assessment are also the reflection of diagnosis and treatment ability. ISS score is an evaluation method for severe trauma and multiple trauma patients. It has been used by emergency personnel for a long time. It also plays a very good auxiliary role in the evaluation and treatment of patients'injuries. However, there are still many problems in the assessment of severe trauma in various parts of China. It is difficult to adapt to the needs of the current medical and health system reform and to meet the needs of the society for the assessment of severe trauma. In the clinical use of ISS scoring, the main problems are as follows: 1. Some hospitals do not attach importance to the application of ISS scoring, and do not fully understand the scoring method; 2. The use of low frequency, inaccurate grasp of the method; 3. Three-level physicians have different evaluation of ISS scoring for the same kind of trauma; 4. Applying AIS scoring table to calculate ISS scoring. It takes a long time to share the time, which affects the normal first aid efficiency.
- Research purposes * By assessing and registering the severity of multiple trauma patients, we can understand and improve the ability of different hospitals and doctors at different levels in different regions to assess the severity of multiple trauma patients, and promote the use of ISS scoring system in national trauma centers. In order to improve the level of understanding of multiple trauma patients and lay a foundation for the establishment of scientific classification and sorting and treatment system.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| multi trauma patients group | – | Other: injury severity score |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with multiple injuries who visited our research centers
Key inclusion criteria (1 listed)
- 1.Age not less than 18 years old; 2. Multiple trauma patients; 3. Complete auxiliary examination data of various trauma sites.
Key exclusion criteria (1 listed)
- Patients who died on the spot or came to hospital; pregnant and lying-in women.
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 |
|---|---|---|
| injury severity scoreinjury severity score of multi trauma patients | Other | multi trauma patients group |
Primary outcome
ISS score of third-level surgeons for the same patient
Time frame: 3 years
ISS score of third-level surgeons for the same patient
Scoring time
Time frame: 3 years
Scoring spending time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
- Background: PubMed 5565650Kirkpatrick JR, Youmans RL. Trauma index. An aide in the evaluation of injury victims. J Trauma. 1971 Aug;11(8):711-4. No abstract available.
- Background: PubMed 3946860Koehler JJ, Baer LJ, Malafa SA, Meindertsma MS, Navitskas NR, Huizenga JE. Prehospital Index: a scoring system for field triage of trauma victims. Ann Emerg Med. 1986 Feb;15(2):178-82. doi: 10.1016/s0196-0644(86)80016-6.
- BackgroundJennett B. The Glasgow Coma Scale: History and current practice. Trauma, 2002, 4(2):91-103.
- Background: PubMed 4814394Baker SP, O'Neill B, Haddon W Jr, Long WB. The injury severity score: a method for describing patients with multiple injuries and evaluating emergency care. J Trauma. 1974 Mar;14(3):187-96. No abstract available.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Trauma/Injuries, 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 1 inclusion and 1 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 2 Jan 2019. 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 Peng ZHANG, Doctor (13001061778, hcooh2001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ISS score of third-level surgeons for the same patient (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT03791333, which also lists 4 linked publications.
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 2 Jan 2019.