<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/NCT03281278</url>
  </required_header>
  <id_info>
    <org_study_id>003</org_study_id>
    <nct_id>NCT03281278</nct_id>
  </id_info>
  <brief_title>A Prospective Study of Application of Platelet Mapping in HBV-related Acute-on-chronic-liver Failure in China</brief_title>
  <official_title>A Prospective Study of Application of Platelet Mapping in HBV-related Acute-on-chronic-liver Failure in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanfang Hospital, Southern Medical 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>
      Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease&#xD;
      (ACLF) has been well established. Thrombelastography measures the dynamics of thrombin&#xD;
      production and provides a global assessment of coagulation incorporating the cumulative&#xD;
      effect of the interactions at various levels between plasma components and cellular component&#xD;
      of coagulation. And through the platelet mapping, it can help provide a picture of patients'&#xD;
      function of platelet. This study aims to explore the predictive role of platelet mapping in&#xD;
      ACLF prognosis, organ failure developments and short term mortality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Actual">August 13, 2018</completion_date>
  <primary_completion_date type="Actual">August 13, 2018</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>28-day mortality</measure>
    <time_frame>28-day</time_frame>
    <description>death within 28-day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>28-day progression</measure>
    <time_frame>28-day</time_frame>
    <description>progressed to EASL defined ACLF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90-day mortality</measure>
    <time_frame>90-day</time_frame>
    <description>death within 90-day</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Thrombelastography,Acute on Chronic Liver Failure, Platelet</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard treatment</intervention_name>
    <description>standard medical treatment</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with HBV-related chronic liver disease, International Normalized Ratio (INR)≥1.5&#xD;
        and total bilirubin≥85μmol/L&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient with previously diagnosed or undiagnosed HBV related chronic liver&#xD;
             disease/cirrhosis&#xD;
&#xD;
          -  INR≥1.5 and total bilirubin≥85μmol/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  INR≤1.5 or total bilirubin≤85μmol/L;&#xD;
&#xD;
          -  underlying chronic liver disease was other than chronic HBV infection related;&#xD;
&#xD;
          -  those who had hepatocellular carcinoma or other types of malignancies;&#xD;
&#xD;
          -  obstructive biliary diseases or other disease lead to bilirubin evaluation;&#xD;
&#xD;
          -  those who had acute hemorrhage one week before admission&#xD;
&#xD;
          -  those who received platelet, cryo transfusion or plasmapheresis one week before&#xD;
             admission&#xD;
&#xD;
          -  using steroid or immunosuppressant or antiplatelet or anticoagulant drugs in 4 weeks&#xD;
&#xD;
          -  any kind of decompensation which persisted over a month&#xD;
&#xD;
          -  pregnancy and breastfeeding&#xD;
&#xD;
          -  those who received liver transplantation or kidney transplantation;&#xD;
&#xD;
          -  combine with other disease lead to organ failure including heart failure (NYHA&#xD;
             IV),respiratory failure（PaO2&lt;60mmHg),renal insufficiency(CKD 5) and conscious&#xD;
             disturbance (GCS&lt;8)&#xD;
&#xD;
          -  readmission;&#xD;
&#xD;
          -  death within 24 hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nanfang Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>June 4, 2019</last_update_submitted>
  <last_update_submitted_qc>June 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Thrombelastography,acute on chronic liver failure, platelet</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Failure</mesh_term>
    <mesh_term>Hepatic Insufficiency</mesh_term>
    <mesh_term>End Stage Liver Disease</mesh_term>
    <mesh_term>Acute-On-Chronic Liver Failure</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/NCT03281278
org study id: 003
nct id: NCT03281278
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease
      (ACLF) has been well established. Thrombelastography measures the dynamics of thrombin
      production and provides a global assessment of coagulation incorporating the cumulative
      effect of the interactions at various levels between plasma components and cellular component
      of coagulation. And through the platelet mapping, it can help provide a picture of patients'
      function of platelet. This study aims to explore the predictive role of platelet mapping in
      ACLF prognosis, organ failure developments and short term mortality.
observational model: Cohort
time perspective: Prospective
measure: 28-day mortality
time frame: 28-day
description: death within 28-day
measure: 28-day progression
time frame: 28-day
description: progressed to EASL defined ACLF
measure: 90-day mortality
time frame: 90-day
description: death within 90-day
intervention type: Other
intervention name: standard treatment
description: standard medical treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Liver Failure
mesh term: Hepatic Insufficiency
mesh term: End Stage Liver Disease
mesh term: Acute-On-Chronic Liver Failure