xml: <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/NCT05998733</url>
    </required_header>
    <id_info>
      <org_study_id>202300123</org_study_id>
      <nct_id>NCT05998733</nct_id>
    </id_info>
    <brief_title>The Impact of Coagulation Disorders on the Diagnosis and Prognosis of Sepsis</brief_title>
    <official_title>Characteristics of Coagulation in Patients With Sepsis and the Role of Coagulation Disorders in the Development of Disease: a Retrospective Single-center Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ruijin Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ruijin Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The study was a retrospective, single-center clinical study. From all patients admitted to&#xD;
        the emergency ICU during the period of 2013.1.1-2019.12.31, the investigators screened all&#xD;
        patients who met the criteria of 1) ≤7 days from symptom onset to enrollment; 2) patients who&#xD;
        also met the criteria of the presence of clinical infections and Sequential Organ Failure&#xD;
        Assessment (SOFA) score ≥2; and 3) met the exclusion criteria, and retrospectively collected&#xD;
        coagulation indices of the patients before anticoagulation with or without the use of heparin&#xD;
        or low molecular heparin, and recorded the worst values of coagulation function of patients&#xD;
        before heparin were recorded, and the organ function, inflammatory response, immune indexes,&#xD;
        and conversion rate of severe disease were observed, so as to investigate the role of&#xD;
        conventional coagulation indexes (FDP, D-dimer) and thromboelastography in the early&#xD;
        diagnosis of septicemia patients and to indicate the prognosis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2022</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The plasma concentration of fibrin degradation products(FDP) in ug/ml</measure>
      <time_frame>within 3 days of admission before the use of anticoagulant drugs</time_frame>
      <description>The plasma concentration of fibrin degradation products(FDP) was assessed after the participant was enrolled within 3 days of admission before the use of anticoagulant drugs</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The plasma concentration of DDimer in ug/ml</measure>
      <time_frame>within 3 days of admission before the use of anticoagulant drugs</time_frame>
      <description>The plasma concentration of DDimer was assessed after the participant was enrolled within 3 days of admission before the use of anticoagulant drugs</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">552</enrollment>
    <condition>Sepsis</condition>
    <condition>Coagulation Disorder</condition>
    <arm_group>
      <arm_group_label>sepsis group</arm_group_label>
      <description>diagnostic sepsis；age&gt;18；Time from clinical symptoms to admission ≤ 7 days； It also meets the following two criteria: ① clinical infection② Sequential Organ Failure Assessment (SOFA) score ≥ 2 points at admission</description>
    </arm_group>
    <arm_group>
      <arm_group_label>non-sepsis group</arm_group_label>
      <description>diagnostic sepsis；age&gt;18；Time from clinical symptoms to admission ≤ 7 days； It also meets the following two criteria: ① clinical infection②Systemic inflammatory response syndrome(SIRS)，SIRS was defined as the presence of 2 or more of the following: (1) temperature &lt;36℃or &gt;38℃, (2) heart rate &gt;90 beats per minute, (3) respiratory rate &gt;20 breaths per minute or PaCO2 &lt; 32 mm Hg, or (4) white blood cell count ≥12 000 cells/mm3 or≤4000 cells/mm</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Early general coagulation function (5 items of coagulation) and thromboelastogram monitoring</intervention_name>
      <description>Correlation analysis of sepsis severity with FDP and D-Dimer&#xD;
  Discussion on the critical value and area under the curve of FDP and D-Dimer in diagnosis of sepsis&#xD;
  Differences in age and sex of FDP and D-Dimer in diagnosis of sepsis&#xD;
  Effect of FDP and D-Dimer diagnosis of sepsis on severe conversion rate and all-cause mortality of patients&#xD;
  The difference of thromboelastogram in patients with sepsis of different severity&#xD;
  Thromboelastogram items (R time α Correlation between angle, k time, maximum blood clot strength and comprehensive coagulation index) and sepsis</description>
      <arm_group_label>non-sepsis group</arm_group_label>
      <arm_group_label>sepsis group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study was a retrospective, single-center clinical study. From all patients admitted to&#xD;
          the emergency ICU during the period 2013.1.1-2019.12.31, all patients who met the&#xD;
          enrollment criteria were screened, and the coagulation function indexes of patients with or&#xD;
          without heparin or low molecular heparin before anticoagulation were retrospectively&#xD;
          collected, the worst value of coagulation function of patients before heparin was recorded,&#xD;
          and the organ function, inflammatory response, immune indexes, and the rate of conversion&#xD;
          to severe disease of the patients were observed, so as to To investigate the role of&#xD;
          conventional coagulation indices (FDP, D-dimer) and thromboelastography in the early&#xD;
          diagnosis and prognosis of patients with sepsis.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Time from clinical symptoms to admission ≤ 7 days；&#xD;
  &#xD;
            -  infection was diagnosed by clinician&#xD;
  &#xD;
            -  Systemic inflammatory response syndrome，Systemic inflammatory response syndrome was&#xD;
               defined as the presence of 2 or more of the following: (1) temperature &lt;36℃or &gt;38℃,&#xD;
               (2) heart rate &gt;90 beats per minute, (3) respiratory rate &gt;20 breaths per minute or&#xD;
               PaCO2 &lt; 32 mm Hg, or (4) white blood cell count ≥12 000 cells/mm3 or≤4000 cells/mm&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy and lactation&#xD;
  &#xD;
            -  Have hematological diseases (including acute and chronic leukemia, hemolytic anemia,&#xD;
               hemophilia, aplastic anemia, bone marrow fibrosis, congenital or acquired coagulation&#xD;
               factor deficiency, etc.)&#xD;
  &#xD;
            -  Anticoagulant or antiplatelet drug treatment&#xD;
  &#xD;
            -  24 hours after severe trauma or surgery&#xD;
  &#xD;
            -  Autoimmune diseases&#xD;
  &#xD;
            -  cirrhosis&#xD;
  &#xD;
            -  Malignant tumor patients with personal history or undergoing radiotherapy,&#xD;
               chemotherapy and targeted treatment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Enqiang Mao, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>peili CHEN, MD</last_name>
      <phone>+86 18502185109</phone>
      <email>elodiechen1986@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Enqiang MAO, PhD</last_name>
      <phone>+86 13501747906</phone>
      <email>maoeq@yeah.net</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Emergency, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200025</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Peili Chen, MD</last_name>
        <phone>+86 18502185109</phone>
        <email>elodiechen1986@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Enqiang Mao, PhD</last_name>
        <phone>+86 13501747906</phone>
        <email>maoeq@yeah.net</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>sepsis</keyword>
    <keyword>coagulation disorders</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sepsis</mesh_term>
      <mesh_term>Toxemia</mesh_term>
      <mesh_term>Hemostatic Disorders</mesh_term>
      <mesh_term>Blood Coagulation Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05998733
  org study id: 202300123
  nct id: NCT05998733
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The study was a retrospective, single-center clinical study. From all patients admitted to
        the emergency ICU during the period of 2013.1.1-2019.12.31, the investigators screened all
        patients who met the criteria of 1) ≤7 days from symptom onset to enrollment; 2) patients who
        also met the criteria of the presence of clinical infections and Sequential Organ Failure
        Assessment (SOFA) score ≥2; and 3) met the exclusion criteria, and retrospectively collected
        coagulation indices of the patients before anticoagulation with or without the use of heparin
        or low molecular heparin, and recorded the worst values of coagulation function of patients
        before heparin were recorded, and the organ function, inflammatory response, immune indexes,
        and conversion rate of severe disease were observed, so as to investigate the role of
        conventional coagulation indexes (FDP, D-dimer) and thromboelastography in the early
        diagnosis of septicemia patients and to indicate the prognosis.
  observational model: Cohort
  time perspective: Retrospective
  measure: The plasma concentration of fibrin degradation products(FDP) in ug/ml
  time frame: within 3 days of admission before the use of anticoagulant drugs
  description: The plasma concentration of fibrin degradation products(FDP) was assessed after the participant was enrolled within 3 days of admission before the use of anticoagulant drugs
  measure: The plasma concentration of DDimer in ug/ml
  time frame: within 3 days of admission before the use of anticoagulant drugs
  description: The plasma concentration of DDimer was assessed after the participant was enrolled within 3 days of admission before the use of anticoagulant drugs
  arm group label: sepsis group
  description: diagnostic sepsis；age>18；Time from clinical symptoms to admission ≤ 7 days； It also meets the following two criteria: ① clinical infection② Sequential Organ Failure Assessment (SOFA) score ≥ 2 points at admission
  arm group label: non-sepsis group
  description: diagnostic sepsis；age>18；Time from clinical symptoms to admission ≤ 7 days； It also meets the following two criteria: ① clinical infection②Systemic inflammatory response syndrome(SIRS)，SIRS was defined as the presence of 2 or more of the following: (1) temperature <36℃or >38℃, (2) heart rate >90 beats per minute, (3) respiratory rate >20 breaths per minute or PaCO2 < 32 mm Hg, or (4) white blood cell count ≥12 000 cells/mm3 or≤4000 cells/mm
  intervention type: Diagnostic Test
  intervention name: Early general coagulation function (5 items of coagulation) and thromboelastogram monitoring
  description: Correlation analysis of sepsis severity with FDP and D-Dimer
  Discussion on the critical value and area under the curve of FDP and D-Dimer in diagnosis of sepsis
  Differences in age and sex of FDP and D-Dimer in diagnosis of sepsis
  Effect of FDP and D-Dimer diagnosis of sepsis on severe conversion rate and all-cause mortality of patients
  The difference of thromboelastogram in patients with sepsis of different severity
  Thromboelastogram items (R time α Correlation between angle, k time, maximum blood clot strength and comprehensive coagulation index) and sepsis
  arm group label: non-sepsis group
  arm group label: sepsis group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  last name: Enqiang Mao, PhD
  role: Study Chair
  affiliation: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
  last name: peili CHEN, MD
  phone: +86 18502185109
  email: elodiechen1986@163.com
  last name: Enqiang MAO, PhD
  phone: +86 13501747906
  email: maoeq@yeah.net
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Sepsis
  mesh term: Toxemia
  mesh term: Hemostatic Disorders
  mesh term: Blood Coagulation Disorders
  sharing ipd: No