<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03791333</url>
  </required_header>
  <id_info>
    <org_study_id>PUPH20181127</org_study_id>
    <nct_id>NCT03791333</nct_id>
  </id_info>
  <brief_title>A Multi-center Clinical Study on the Status of Trauma Evaluating Ability in Patients With Multiple Trauma</brief_title>
  <official_title>A Multi-center Clinical Study on the Status of Trauma Evaluating Ability in Patients With Multiple Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University People's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Trauma is a major medical and public health problem facing all countries in the world today.&#xD;
      Trauma is the leading cause of death worldwide for people under 45 years of age, and more&#xD;
      than 5 million people die each year from severe trauma. According to the &quot;China Injury&#xD;
      Prevention Report&quot; issued by the Ministry of Health in August 2007, about 200 million&#xD;
      injuries occur annually in China, with 700,000 to 750,000 deaths, accounting for about 9% of&#xD;
      the total number of deaths. Serious trauma has the characteristics of high mortality and&#xD;
      disability rate, and often affects the main groups of young and middle-aged people of social&#xD;
      labor force. It has a tremendous impact on social and economic development, and has brought a&#xD;
      heavy burden to society and families. The treatment of severe trauma is extremely important,&#xD;
      and its treatment process needs a standardized model. In many links of trauma treatment,&#xD;
      accurate assessment of injury is the precondition of classification and grading of diagnosis&#xD;
      and treatment, and also provides a good basis for the follow-up standardized treatment of&#xD;
      patients. The accuracy and consistency of injury assessment are also the reflection of&#xD;
      diagnosis and treatment ability. ISS score is an evaluation method for severe trauma and&#xD;
      multiple trauma patients. It has been used by emergency personnel for a long time. It also&#xD;
      plays a very good auxiliary role in the evaluation and treatment of patients'injuries.&#xD;
      However, there are still many problems in the clinical use of ISS scores: 1. Some hospitals&#xD;
      do not attach importance to the application of ISS scores, and do not fully understand the&#xD;
      scoring method; 2. Low frequency of use, inaccurate grasp of the method; 3. Three-level&#xD;
      physicians have different valuations of ISS scores for the same kind of trauma; 4. Use AIS&#xD;
      scoring table to calculate. It takes a long time to calculate the ISS score, which affects&#xD;
      the normal first aid efficiency. To this end, our research team designed a questionnaire on&#xD;
      the use of ISS score. The main purpose of the questionnaire is to assess and register the&#xD;
      severity of injury in multiple trauma patients to understand the current use and proficiency&#xD;
      of ISS score system by Chinese trauma surgeons, the difference of ISS score between&#xD;
      three-level doctors and the same patient, and ISS score. The consistency between the software&#xD;
      and AIS scoring table and the scoring time of the two methods are also discussed. This study&#xD;
      hopes that through this survey, we can understand the current situation of the application of&#xD;
      the scoring system in Chinese hospitals, in order to promote the standardization of severe&#xD;
      trauma assessment and promote the use of the evaluation system in hospitals throughout the&#xD;
      country, so as to provide optimized trauma treatment process for trauma patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Research Background and Basis for Project Establishment* Trauma is a major medical and&#xD;
           public health problem facing all countries in the world today. Trauma is the leading&#xD;
           cause of death worldwide for people under 45 years of age, and more than 5 million&#xD;
           people die each year from severe trauma. According to the &quot;China Injury Prevention&#xD;
           Report&quot; issued by the Ministry of Health in August 2007, about 200 million injuries&#xD;
           occur annually in China, with 700,000 to 750,000 deaths, accounting for about 9% of the&#xD;
           total number of deaths. Serious trauma has the characteristics of high mortality and&#xD;
           disability rate, and often affects the main groups of young and middle-aged people of&#xD;
           social labor force. It has a tremendous impact on social and economic development, and&#xD;
           has brought a heavy burden to society and families. The treatment of severe trauma is&#xD;
           extremely important, and its treatment process needs a standardized model. In many links&#xD;
           of trauma treatment, accurate assessment of injury is the precondition of classification&#xD;
           and grading of diagnosis and treatment, and also provides a good basis for the follow-up&#xD;
           standardized treatment of patients. The accuracy and consistency of injury assessment&#xD;
           are also the reflection of diagnosis and treatment ability. ISS score is an evaluation&#xD;
           method for severe trauma and multiple trauma patients. It has been used by emergency&#xD;
           personnel for a long time. It also plays a very good auxiliary role in the evaluation&#xD;
           and treatment of patients'injuries. However, there are still many problems in the&#xD;
           assessment of severe trauma in various parts of China. It is difficult to adapt to the&#xD;
           needs of the current medical and health system reform and to meet the needs of the&#xD;
           society for the assessment of severe trauma. In the clinical use of ISS scoring, the&#xD;
           main problems are as follows: 1. Some hospitals do not attach importance to the&#xD;
           application of ISS scoring, and do not fully understand the scoring method; 2. The use&#xD;
           of low frequency, inaccurate grasp of the method; 3. Three-level physicians have&#xD;
           different evaluation of ISS scoring for the same kind of trauma; 4. Applying AIS scoring&#xD;
           table to calculate ISS scoring. It takes a long time to share the time, which affects&#xD;
           the normal first aid efficiency.&#xD;
&#xD;
        2. Research purposes * By assessing and registering the severity of multiple trauma&#xD;
           patients, we can understand and improve the ability of different hospitals and doctors&#xD;
           at different levels in different regions to assess the severity of multiple trauma&#xD;
           patients, and promote the use of ISS scoring system in national trauma centers. In order&#xD;
           to improve the level of understanding of multiple trauma patients and lay a foundation&#xD;
           for the establishment of scientific classification and sorting and treatment system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ISS score of third-level surgeons for the same patient</measure>
    <time_frame>3 years</time_frame>
    <description>ISS score of third-level surgeons for the same patient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scoring time</measure>
    <time_frame>3 years</time_frame>
    <description>Scoring spending time</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3600</enrollment>
  <condition>Multiple Trauma/Injuries</condition>
  <arm_group>
    <arm_group_label>multi trauma patients group</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>injury severity score</intervention_name>
    <description>injury severity score of multi trauma patients</description>
    <arm_group_label>multi trauma patients group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with multiple injuries who visited our research centers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1.Age not less than 18 years old; 2. Multiple trauma patients; 3. Complete auxiliary&#xD;
             examination data of various trauma sites.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who died on the spot or came to hospital; pregnant and lying-in women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Peng ZHANG, Doctor</last_name>
    <phone>13001061778</phone>
    <email>hcooh2001@163.com</email>
  </overall_contact>
  <reference>
    <citation>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.</citation>
    <PMID>5565650</PMID>
  </reference>
  <reference>
    <citation>Koehler 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.</citation>
    <PMID>3946860</PMID>
  </reference>
  <reference>
    <citation>Jennett B. The Glasgow Coma Scale: History and current practice. Trauma, 2002, 4(2):91-103.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>4814394</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 31, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>December 31, 2018</last_update_submitted>
  <last_update_submitted_qc>December 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University People's Hospital</investigator_affiliation>
    <investigator_full_name>wang tianbing</investigator_full_name>
    <investigator_title>department of orthopaedic and trauma</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Multiple Trauma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03791333
org study id: PUPH20181127
nct id: NCT03791333
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
1. 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.

        2. 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.
observational model: Case-Only
time perspective: Prospective
measure: ISS score of third-level surgeons for the same patient
time frame: 3 years
description: ISS score of third-level surgeons for the same patient
measure: Scoring time
time frame: 3 years
description: Scoring spending time
arm group label: multi trauma patients group
intervention type: Other
intervention name: injury severity score
description: injury severity score of multi trauma patients
arm group label: multi trauma patients group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peng ZHANG, Doctor
phone: 13001061778
email: hcooh2001@163.com
citation: 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.
PMID: 5565650
citation: Koehler 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.
PMID: 3946860
citation: Jennett B. The Glasgow Coma Scale: History and current practice. Trauma, 2002, 4(2):91-103.
citation: 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.
PMID: 4814394
responsible party type: Principal Investigator
investigator affiliation: Peking University People's Hospital
investigator full name: wang tianbing
investigator title: department of orthopaedic and trauma
mesh term: Wounds and Injuries
mesh term: Multiple Trauma
sharing ipd: Undecided