<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/NCT03281252</url>
  </required_header>
  <id_info>
    <org_study_id>001</org_study_id>
    <nct_id>NCT03281252</nct_id>
  </id_info>
  <brief_title>A Prospective Study of Evaluation of Minor Bleeding and Utility of Bleeding Criteria in Acute-on-chronic Liver Failure Patients in China</brief_title>
  <official_title>A Prospective Study of Evaluation of Minor Bleeding and Utility of Bleeding Criteria in Acute-on-chronic Liver Failure Patients 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. However, the minor and major bleeding events has not been&#xD;
      described yet. We observe the patients' major and minor bleeding events and use 4 criteria,&#xD;
      which include BARC, ISTH, TIMI, Gusto ,to evaluate the incident rate of bleeding events in&#xD;
      ACLF patients and pre-ACLF patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 16, 2017</start_date>
  <completion_date type="Anticipated">September 16, 2017</completion_date>
  <primary_completion_date type="Anticipated">September 16, 2017</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 progression</measure>
    <time_frame>28-day</time_frame>
    <description>progressed to EASL or APASL defined ACLF or death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>major bleeding event</measure>
    <time_frame>90-day</time_frame>
    <description>major bleeding event happen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>28-day mortality</measure>
    <time_frame>28-day</time_frame>
    <description>death within 28 days</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Liver Failure, Acute on Chronic</condition>
  <condition>Hemostatic Disorder</condition>
  <eligibility>
    <study_pop>
      <textblock>
        pre-acute-on-chronic liver failure and acute-on-chronic liver failure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient with previously or undiagnosed chronic liver disease/cirrhosis;&#xD;
&#xD;
          -  serum bilirubin higher than 3 mg/dl (51 mmol/L) or ALT&gt;10ULN（male 300 U/L; female 200&#xD;
             U/L)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  those who had or been diagnosed hepatocellular carcinoma or other types of&#xD;
             malignancies;&#xD;
&#xD;
          -  pregnancy;&#xD;
&#xD;
          -  obstructive biliary diseases or other disease lead to bilirubin evaluation;&#xD;
&#xD;
          -  using steroid or immunosuppressant in 4 weeks;&#xD;
&#xD;
          -  prior surgeries including splenectomy，subtotal splenectomy and disconnection，liver&#xD;
             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;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jinjun Chen, PHD</last_name>
    <phone>0086-18588531001</phone>
    <email>chjj@smu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xutong Yu, Bachelor</last_name>
    <phone>0086-15602339371</phone>
    <email>nancy2003yu@aliyun.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nanfang Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aishan Su</last_name>
      <phone>02064786845</phone>
      <email>nfyyqx@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</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>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>liver failure</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>
    <mesh_term>Liver Failure, Acute</mesh_term>
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
    <mesh_term>Hemorrhage</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/NCT03281252
org study id: 001
nct id: NCT03281252
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. However, the minor and major bleeding events has not been
      described yet. We observe the patients' major and minor bleeding events and use 4 criteria,
      which include BARC, ISTH, TIMI, Gusto ,to evaluate the incident rate of bleeding events in
      ACLF patients and pre-ACLF patients.
observational model: Cohort
time perspective: Prospective
measure: 28-day progression
time frame: 28-day
description: progressed to EASL or APASL defined ACLF or death
measure: major bleeding event
time frame: 90-day
description: major bleeding event happen
measure: 28-day mortality
time frame: 28-day
description: death within 28 days
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jinjun Chen, PHD
phone: 0086-18588531001
email: chjj@smu.edu.cn
last name: Xutong Yu, Bachelor
phone: 0086-15602339371
email: nancy2003yu@aliyun.com
facility: 
status: Recruiting
contact: 
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
mesh term: Liver Failure, Acute
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
mesh term: Hemorrhage