<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/NCT01713205</url>
  </required_header>
  <id_info>
    <org_study_id>Jiang-2012BAI11B01</org_study_id>
    <secondary_id>2012BAI11B01</secondary_id>
    <nct_id>NCT01713205</nct_id>
  </id_info>
  <brief_title>Prediction Study of Complications After Severe Trauma</brief_title>
  <acronym>PSCAT</acronym>
  <official_title>Identifying Severe Trauma Patients at High Risk of Post-traumatic Complications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiang Jianxin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chongqing Emergency Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kunming general Hospital of Chengdu Military Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Affiliated Hospital Of Guizhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate a clinically and economically most effective&#xD;
      diagnostic algorithm for prediction of post-traumatic complications in a multicenter sample&#xD;
      of severe trauma patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Trauma is a major public health problem worldwide, ranking as the fourth leading cause of&#xD;
      death. One of the most serious complications of major trauma is sepsis, which often induces&#xD;
      sequential multiple organ dysfunction syndrome (MODS). There were still no specific&#xD;
      biomarkers to predict the susceptibility of complications and outcomes, which leading to the&#xD;
      limited prevention methods and the high mortality rate of severe trauma patients. Previous&#xD;
      studies from our and other group have found some sepsis and MODS predictors, including&#xD;
      genetic polymorphisms, serum cytokines and cell-surface markers. The purposes of this&#xD;
      multi-center observational study is to select biomarkers and evaluate a clinically and&#xD;
      economically most effective diagnostic algorithm for prediction of complications in severe&#xD;
      trauma patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>morbidity rate of complications after trauma (including sepsis and MODS)</measure>
    <time_frame>patients will be followed for the duration of hospital stay, an expected average of 3 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>survival</measure>
    <time_frame>witnin 30 days and 60 days after injury</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">3500</enrollment>
  <condition>Trauma</condition>
  <condition>Sepsis</condition>
  <condition>Multiple Organ Dysfunction Syndrome</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood, serum, white cells, urine and tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult severe trauma patients with no serious co-morbidity&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age&gt; 16 years old and &lt;65 years old&#xD;
&#xD;
          -  severe trauma patients (AIS ≧3 or ISS≧16)&#xD;
&#xD;
          -  admission within 48 hours after injury&#xD;
&#xD;
          -  given and signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  died within 48h after injury&#xD;
&#xD;
          -  being pregnant or lactating&#xD;
&#xD;
          -  chronic organ dysfunction comorbidities&#xD;
&#xD;
          -  long-term anticoagulant therapy before injury&#xD;
&#xD;
          -  presence of immunosuppression before injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianxin Jiang, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Daping Hospital/Research Institute of Surgery, Third Military Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anqiang Zhang, MD</last_name>
    <phone>+86-23-68757402</phone>
    <email>zhanganqiang@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Emergency Surgery, The Affiliated Hospital of Guizhou Medical University</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <zip>550004</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin Deng, MD</last_name>
      <phone>+86-851-86771474</phone>
      <email>Dengjin6067@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiangjun Bai, MD,PhD</last_name>
      <phone>+86-27-83663669</phone>
      <email>baixiangjun@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Xiangjun Bai, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kunming General Hospital of Chengdu Military Region</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiang Hao, MD,PhD</last_name>
      <phone>+86-871-64774999</phone>
      <email>kmlmhj@sina.com</email>
    </contact>
    <investigator>
      <last_name>Jiang Hao, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Second Affiliated Hospital, School of Medicine, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mao Zhang, MD,PhD</last_name>
      <phone>+86-571-87783803</phone>
      <email>zmhz@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Mao Zhang, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chongqing Emergency Medical Center</name>
      <address>
        <city>Chongqing</city>
        <zip>400014</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dingyuan Du, MD，PhD</last_name>
      <phone>+86-23-63692110</phone>
      <email>dudingyuan@qq.com.cn</email>
    </contact>
    <investigator>
      <last_name>Dingyuan Du, MD，PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Daping Hospital / Research Institute of Surgery, the Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <zip>400042</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lianyang Zhang, MD,PhD</last_name>
      <phone>+86-23-68757991</phone>
      <email>hapzhangly@163.com</email>
    </contact>
    <investigator>
      <last_name>Lianyang Zhang, MD，PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jianxin Jiang, MD，PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Gu W, Jiang J. Genetic polymorphisms and posttraumatic complications. Comp Funct Genomics. 2010;2010:814086. doi: 10.1155/2010/814086. Epub 2011 Jan 11.</citation>
    <PMID>21274447</PMID>
  </reference>
  <results_reference>
    <citation>Gu W, Zeng L, Zhang LY, Jiang DP, Du DY, Hu P, Wang HY, Liu Q, Huang SN, Jiang JX. Association of interleukin 4 -589T/C polymorphism with T(H)1 and T(H)2 bias and sepsis in Chinese major trauma patients. J Trauma. 2011 Dec;71(6):1583-7. doi: 10.1097/TA.0b013e3182115034.</citation>
    <PMID>21460743</PMID>
  </results_reference>
  <results_reference>
    <citation>Chen KH, Zeng L, Gu W, Zhou J, Du DY, Jiang JX. Polymorphisms in the toll-like receptor 9 gene associated with sepsis and multiple organ dysfunction after major blunt trauma. Br J Surg. 2011 Sep;98(9):1252-9. doi: 10.1002/bjs.7532. Epub 2011 Jun 1.</citation>
    <PMID>21633947</PMID>
  </results_reference>
  <results_reference>
    <citation>Zeng L, Zhang AQ, Gu W, Chen KH, Jiang DP, Zhang LY, Du DY, Hu P, Huang SN, Wang HY, Jiang JX. Clinical relevance of single nucleotide polymorphisms of the high mobility group box 1 protein gene in patients with major trauma in southwest China. Surgery. 2012 Mar;151(3):427-36. doi: 10.1016/j.surg.2011.07.075. Epub 2011 Nov 1.</citation>
    <PMID>22047946</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhang AQ, Zeng L, Gu W, Zhang LY, Zhou J, Jiang DP, Du DY, Hu P, Yang C, Yan J, Wang HY, Jiang JX. Clinical relevance of single nucleotide polymorphisms within the entire NLRP3 gene in patients with major blunt trauma. Crit Care. 2011;15(6):R280. doi: 10.1186/cc10564. Epub 2011 Nov 23.</citation>
    <PMID>22112657</PMID>
  </results_reference>
  <results_reference>
    <citation>Zeng L, Gu W, Zhang AQ, Zhang M, Zhang LY, Du DY, Huang SN, Jiang JX. A functional variant of lipopolysaccharide binding protein predisposes to sepsis and organ dysfunction in patients with major trauma. Ann Surg. 2012 Jan;255(1):147-57. doi: 10.1097/SLA.0b013e3182389515.</citation>
    <PMID>22167001</PMID>
  </results_reference>
  <results_reference>
    <citation>Zeng L, Zhang AQ, Gu W, Zhou J, Zhang LY, Du DY, Zhang M, Wang HY, Jiang JX. Identification of haplotype tag SNPs within the whole myeloid differentiation 2 gene and their clinical relevance in patients with major trauma. Shock. 2012 Apr;37(4):366-72. doi: 10.1097/SHK.0b013e3182498c8f.</citation>
    <PMID>22266968</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhang AQ, Gu W, Zeng L, Zhang LY, Du DY, Zhang M, Hao J, Yue CL, Jiang J. Genetic variants of microRNA sequences and susceptibility to sepsis in patients with major blunt trauma. Ann Surg. 2015 Jan;261(1):189-96. doi: 10.1097/SLA.0000000000000687.</citation>
    <PMID>24743625</PMID>
  </results_reference>
  <results_reference>
    <citation>Zeng L, Du J, Gu W, Zhang AQ, Wang HY, Wen DL, Qiu L, Yang XT, Sun JH, Zhang M, Hao J, Jiang JX. Rs1800625 in the receptor for advanced glycation end products gene predisposes to sepsis and multiple organ dysfunction syndrome in patients with major trauma. Crit Care. 2015 Jan 9;19(1):6. doi: 10.1186/s13054-014-0727-2.</citation>
    <PMID>25572180</PMID>
  </results_reference>
  <results_reference>
    <citation>Pan W, Zhang AQ, Gu W, Gao JW, Du DY, Zhang LY, Zeng L, Du J, Wang HY, Jiang JX. Identification of haplotype tag single nucleotide polymorphisms within the nuclear factor-kappaB family genes and their clinical relevance in patients with major trauma. Crit Care. 2015 Mar 20;19(1):95. doi: 10.1186/s13054-015-0836-6.</citation>
    <PMID>25880845</PMID>
  </results_reference>
  <results_reference>
    <citation>Gao JW, Zeng L, Zhang AQ, Wang X, Pan W, Du DY, Zhang LY, Gu W, Jiang JX. Identification of Haplotype Tag Single-Nucleotide Polymorphisms within the PPAR Family Genes and Their Clinical Relevance in Patients with Major Trauma. Int J Environ Res Public Health. 2016 Mar 26;13(4):374. doi: 10.3390/ijerph13040374.</citation>
    <PMID>27023591</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhang H, Lu Y, Sun G, Teng F, Luo N, Jiang J, Wen A. The common promoter polymorphism rs11666254 downregulates FPR2/ALX expression and increases risk of sepsis in patients with severe trauma. Crit Care. 2017 Jul 6;21(1):171. doi: 10.1186/s13054-017-1757-3.</citation>
    <PMID>28679406</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhang A, Gu W, Lu H, Zeng L, Zhang L, Du D, Hao J, Wen D, Wang X, Jiang J. Genetic contribution of suppressor of cytokine signalling polymorphisms to the susceptibility to infection after traumatic injury. Clin Exp Immunol. 2018 Oct;194(1):93-102. doi: 10.1111/cei.13160. Epub 2018 Sep 9.</citation>
    <PMID>29920655</PMID>
  </results_reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>July 28, 2022</last_update_submitted>
  <last_update_submitted_qc>July 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</investigator_affiliation>
    <investigator_full_name>Jiang Jianxin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>trauma ; sepsis; Multiple Organ Dysfunction Syndrome; Prediction; risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Organ Failure</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT01713205
org study id: Jiang-2012BAI11B01
secondary id: 2012BAI11B01
nct id: NCT01713205
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate a clinically and economically most effective
      diagnostic algorithm for prediction of post-traumatic complications in a multicenter sample
      of severe trauma patients.
Trauma is a major public health problem worldwide, ranking as the fourth leading cause of
      death. One of the most serious complications of major trauma is sepsis, which often induces
      sequential multiple organ dysfunction syndrome (MODS). There were still no specific
      biomarkers to predict the susceptibility of complications and outcomes, which leading to the
      limited prevention methods and the high mortality rate of severe trauma patients. Previous
      studies from our and other group have found some sepsis and MODS predictors, including
      genetic polymorphisms, serum cytokines and cell-surface markers. The purposes of this
      multi-center observational study is to select biomarkers and evaluate a clinically and
      economically most effective diagnostic algorithm for prediction of complications in severe
      trauma patients.
observational model: Cohort
time perspective: Prospective
measure: morbidity rate of complications after trauma (including sepsis and MODS)
time frame: patients will be followed for the duration of hospital stay, an expected average of 3 weeks
measure: survival
time frame: witnin 30 days and 60 days after injury
whole blood, serum, white cells, urine and tissue
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jianxin Jiang, MD,PhD
role: Principal Investigator
affiliation: Daping Hospital/Research Institute of Surgery, Third Military Medical University
last name: Anqiang Zhang, MD
phone: +86-23-68757402
email: zhanganqiang@126.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
citation: Gu W, Jiang J. Genetic polymorphisms and posttraumatic complications. Comp Funct Genomics. 2010;2010:814086. doi: 10.1155/2010/814086. Epub 2011 Jan 11.
PMID: 21274447
citation: Gu W, Zeng L, Zhang LY, Jiang DP, Du DY, Hu P, Wang HY, Liu Q, Huang SN, Jiang JX. Association of interleukin 4 -589T/C polymorphism with T(H)1 and T(H)2 bias and sepsis in Chinese major trauma patients. J Trauma. 2011 Dec;71(6):1583-7. doi: 10.1097/TA.0b013e3182115034.
PMID: 21460743
citation: Chen KH, Zeng L, Gu W, Zhou J, Du DY, Jiang JX. Polymorphisms in the toll-like receptor 9 gene associated with sepsis and multiple organ dysfunction after major blunt trauma. Br J Surg. 2011 Sep;98(9):1252-9. doi: 10.1002/bjs.7532. Epub 2011 Jun 1.
PMID: 21633947
citation: Zeng L, Zhang AQ, Gu W, Chen KH, Jiang DP, Zhang LY, Du DY, Hu P, Huang SN, Wang HY, Jiang JX. Clinical relevance of single nucleotide polymorphisms of the high mobility group box 1 protein gene in patients with major trauma in southwest China. Surgery. 2012 Mar;151(3):427-36. doi: 10.1016/j.surg.2011.07.075. Epub 2011 Nov 1.
PMID: 22047946
citation: Zhang AQ, Zeng L, Gu W, Zhang LY, Zhou J, Jiang DP, Du DY, Hu P, Yang C, Yan J, Wang HY, Jiang JX. Clinical relevance of single nucleotide polymorphisms within the entire NLRP3 gene in patients with major blunt trauma. Crit Care. 2011;15(6):R280. doi: 10.1186/cc10564. Epub 2011 Nov 23.
PMID: 22112657
citation: Zeng L, Gu W, Zhang AQ, Zhang M, Zhang LY, Du DY, Huang SN, Jiang JX. A functional variant of lipopolysaccharide binding protein predisposes to sepsis and organ dysfunction in patients with major trauma. Ann Surg. 2012 Jan;255(1):147-57. doi: 10.1097/SLA.0b013e3182389515.
PMID: 22167001
citation: Zeng L, Zhang AQ, Gu W, Zhou J, Zhang LY, Du DY, Zhang M, Wang HY, Jiang JX. Identification of haplotype tag SNPs within the whole myeloid differentiation 2 gene and their clinical relevance in patients with major trauma. Shock. 2012 Apr;37(4):366-72. doi: 10.1097/SHK.0b013e3182498c8f.
PMID: 22266968
citation: Zhang AQ, Gu W, Zeng L, Zhang LY, Du DY, Zhang M, Hao J, Yue CL, Jiang J. Genetic variants of microRNA sequences and susceptibility to sepsis in patients with major blunt trauma. Ann Surg. 2015 Jan;261(1):189-96. doi: 10.1097/SLA.0000000000000687.
PMID: 24743625
citation: Zeng L, Du J, Gu W, Zhang AQ, Wang HY, Wen DL, Qiu L, Yang XT, Sun JH, Zhang M, Hao J, Jiang JX. Rs1800625 in the receptor for advanced glycation end products gene predisposes to sepsis and multiple organ dysfunction syndrome in patients with major trauma. Crit Care. 2015 Jan 9;19(1):6. doi: 10.1186/s13054-014-0727-2.
PMID: 25572180
citation: Pan W, Zhang AQ, Gu W, Gao JW, Du DY, Zhang LY, Zeng L, Du J, Wang HY, Jiang JX. Identification of haplotype tag single nucleotide polymorphisms within the nuclear factor-kappaB family genes and their clinical relevance in patients with major trauma. Crit Care. 2015 Mar 20;19(1):95. doi: 10.1186/s13054-015-0836-6.
PMID: 25880845
citation: Gao JW, Zeng L, Zhang AQ, Wang X, Pan W, Du DY, Zhang LY, Gu W, Jiang JX. Identification of Haplotype Tag Single-Nucleotide Polymorphisms within the PPAR Family Genes and Their Clinical Relevance in Patients with Major Trauma. Int J Environ Res Public Health. 2016 Mar 26;13(4):374. doi: 10.3390/ijerph13040374.
PMID: 27023591
citation: Zhang H, Lu Y, Sun G, Teng F, Luo N, Jiang J, Wen A. The common promoter polymorphism rs11666254 downregulates FPR2/ALX expression and increases risk of sepsis in patients with severe trauma. Crit Care. 2017 Jul 6;21(1):171. doi: 10.1186/s13054-017-1757-3.
PMID: 28679406
citation: Zhang A, Gu W, Lu H, Zeng L, Zhang L, Du D, Hao J, Wen D, Wang X, Jiang J. Genetic contribution of suppressor of cytokine signalling polymorphisms to the susceptibility to infection after traumatic injury. Clin Exp Immunol. 2018 Oct;194(1):93-102. doi: 10.1111/cei.13160. Epub 2018 Sep 9.
PMID: 29920655
responsible party type: Sponsor-Investigator
investigator affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
investigator full name: Jiang Jianxin
investigator title: Principal Investigator
mesh term: Multiple Organ Failure
mesh term: Wounds and Injuries