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/NCT05995093</url>
    </required_header>
    <id_info>
      <org_study_id>Hemostatic Biomarkers in DIC</org_study_id>
      <nct_id>NCT05995093</nct_id>
    </id_info>
    <brief_title>The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation</brief_title>
    <official_title>The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qilu Hospital of Shandong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Qilu Hospital of Shandong University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The project was undertaking by Qilu Hospital of Shandong University, aiming to evaluate&#xD;
        diagnostic performance of hemostatic biomarkers in disseminated intravascular coagulation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Disseminated intravascular coagulation (DIC) is a life-threatening condition with high&#xD;
        mortality, necessitating timely and accurate diagnosis for effective management. However,&#xD;
        current diagnostic systems can not recognize DIC at its reversible phase, causing suboptimal&#xD;
        treatment outcomes. Consequently, the current diagnostic criteria for DIC lacks earlier&#xD;
        laboratory indicators. Therefore, the investigators aimed to assess the diagnostic potential&#xD;
        of selected hemostatic biomarkers, including thrombin-antithrombin complex (TAT), soluble&#xD;
        thrombomodulin (sTM), tissue plasminogen activator inhibitor complex (tPAI-C), α2-plasmin&#xD;
        inhibitor plasmin complex (PIC) and anti-thrombin III (ATIII), in evaluating DIC, allowing&#xD;
        for proactive diagnosis before the disease progresses into its irreversible phase.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>whether DIC occured</measure>
      <time_frame>From date of detecting hemostatic biomarkers until the date of first ISTH-DIC scores ≥5, assessed up to 7 days.</time_frame>
      <description>DIC includes pre-DIC and overt-DIC</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>whether death occurred</measure>
      <time_frame>From date of admission until the date of death, assessed up to 5 months</time_frame>
      <description>Based on the death records in the electronic medical records</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">462</enrollment>
    <condition>Disseminated Intravascular Coagulation</condition>
    <arm_group>
      <arm_group_label>non-DIC group</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>pre-DIC group</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>overt-DIC group</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>DIC group</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>no intervention</intervention_name>
      <description>no intervention</description>
      <arm_group_label>DIC group</arm_group_label>
      <arm_group_label>non-DIC group</arm_group_label>
      <arm_group_label>overt-DIC group</arm_group_label>
      <arm_group_label>pre-DIC group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adults patients admitted to intensive care unit of Qilu Hospital from 1 January 2021 to 31&#xD;
          December 2022 were involved in our study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years old, non-perinatal period, a hospitalization length of≥3 days.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  primary hematologic diseases, decompensated liver cirrhosis, chemotherapy history.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>94 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Miao Xu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Qilu Hospital of Shandong University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Miao Xu</last_name>
      <phone>0531-82169885</phone>
      <email>miao.xu@sdu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Miao Xu</name>
        <address>
          <city>Ji'nan</city>
          <state>Shandong</state>
          <zip>250000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Miao Xu, MD, PhD</last_name>
        <phone>0531-82169885</phone>
        <email>miao.xu@sdu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Qilu Hospital of Shandong University</investigator_affiliation>
      <investigator_full_name>Miao Xu, MD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Thrombosis</keyword>
    <keyword>Coagulation</keyword>
    <keyword>Hemostatic Biomarkers</keyword>
    <keyword>DIC</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Disseminated Intravascular Coagulation</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/NCT05995093
  org study id: Hemostatic Biomarkers in DIC
  nct id: NCT05995093
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The project was undertaking by Qilu Hospital of Shandong University, aiming to evaluate
        diagnostic performance of hemostatic biomarkers in disseminated intravascular coagulation.
  Disseminated intravascular coagulation (DIC) is a life-threatening condition with high
        mortality, necessitating timely and accurate diagnosis for effective management. However,
        current diagnostic systems can not recognize DIC at its reversible phase, causing suboptimal
        treatment outcomes. Consequently, the current diagnostic criteria for DIC lacks earlier
        laboratory indicators. Therefore, the investigators aimed to assess the diagnostic potential
        of selected hemostatic biomarkers, including thrombin-antithrombin complex (TAT), soluble
        thrombomodulin (sTM), tissue plasminogen activator inhibitor complex (tPAI-C), α2-plasmin
        inhibitor plasmin complex (PIC) and anti-thrombin III (ATIII), in evaluating DIC, allowing
        for proactive diagnosis before the disease progresses into its irreversible phase.
  observational model: Case-Control
  time perspective: Retrospective
  measure: whether DIC occured
  time frame: From date of detecting hemostatic biomarkers until the date of first ISTH-DIC scores ≥5, assessed up to 7 days.
  description: DIC includes pre-DIC and overt-DIC
  measure: whether death occurred
  time frame: From date of admission until the date of death, assessed up to 5 months
  description: Based on the death records in the electronic medical records
  arm group label: non-DIC group
  arm group label: pre-DIC group
  arm group label: overt-DIC group
  arm group label: DIC group
  intervention type: Other
  intervention name: no intervention
  description: no intervention
  arm group label: DIC group
  arm group label: non-DIC group
  arm group label: overt-DIC group
  arm group label: pre-DIC group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 94 Years
  healthy volunteers: No
  last name: Miao Xu
  role: Principal Investigator
  affiliation: Qilu Hospital of Shandong University
  last name: Miao Xu
  phone: 0531-82169885
  email: miao.xu@sdu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Qilu Hospital of Shandong University
  investigator full name: Miao Xu, MD
  investigator title: Principal Investigator
  mesh term: Disseminated Intravascular Coagulation
  sharing ipd: No