<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/NCT03028064</url>
  </required_header>
  <id_info>
    <org_study_id>POCGIB</org_study_id>
    <nct_id>NCT03028064</nct_id>
  </id_info>
  <brief_title>Point of Care Testing of Platelet Function in Patients With Acute Upper Gastrointestinal Bleeding</brief_title>
  <acronym>POCGIB</acronym>
  <official_title>Point of Care Testing of Platelet Function in Patients With Acute Upper Gastrointestinal Bleeding</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <brief_summary>
    <textblock>
      Acute upper gastrointestinal bleeding (AUGIB) is a common medical emergency. In an ageing&#xD;
      population, antiplatelet drugs are increasingly being prescribed for treatment and&#xD;
      prophylaxis against cardiovascular thrombo-embolic events. In many patients, platelet&#xD;
      dysfunction mostly acquired is the principal cause of bleeding. To clinicians, the management&#xD;
      of patients on antiplatelet drugs or anticoagulants is a challenge. One has to carefully&#xD;
      balance the bleeding against thrombo-embolic risks. Therefore measuring platelet function&#xD;
      should be integral in the management plan. A quantitative measurement allows titration of&#xD;
      platelet function in accordance with bleeding or thromboembolic risk. Platelet function has&#xD;
      not been studied in a large cohort of patients with acute upper gastrointestinal bleeding. As&#xD;
      a first step, the study will determine if platelet dysfunction is associated with clinical&#xD;
      outcome. In this prospective, observational single centre cohort study of consecutive&#xD;
      patients with overt signs of acute upper gastrointestinal bleeding, their platelet function&#xD;
      by point of care tests (light transmittance aggregometry, verify now p2y12,the platelet&#xD;
      function analysis system (PFA-100) upon their admissions. Patients will be followed up for 30&#xD;
      days after trial enrollment. The primary endpoint is defined as significant bleeding that&#xD;
      requires interventions (endoscopic, radiologic or surgery). Secondary end points include&#xD;
      cardio- and cerebrovascular thrombo-embolic events and all cause deaths. A receiver operating&#xD;
      characteristic (ROC) curve analysis is calculated for each point-of-care test to evaluate if&#xD;
      individual test can distinguish between patients with and without primary end point. This&#xD;
      study aims to evaluate the capability of platelet function tests to predict clinical outcome&#xD;
      in patients with AUGIB. Logistic regression models will then be built in search for&#xD;
      independent correlates to the primary and secondary endpoints and to adjust for confounding&#xD;
      variables.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2017</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</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>Active bleeding that requires interventions (endoscopic, radiologic or surgery)</measure>
    <time_frame>within 30 days of trial inclusion</time_frame>
    <description>Data on whether patients experience further bleeding that requires interventions, the type of interventions and the time of further bleeding after trial inclusion, will be collected through electronic medical record</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All cause deaths, cardiovascular or cerebral thrombotic events</measure>
    <time_frame>within 30 days of trial inclusion</time_frame>
    <description>All cause deaths, cardiovascular or cerebral thrombotic events</description>
  </secondary_outcome>
  <enrollment type="Actual">476</enrollment>
  <condition>Hematemesis</condition>
  <condition>Melena</condition>
  <condition>Gastrointestinal Hemorrhage</condition>
  <condition>Platelet Dysfunction</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood taking</intervention_name>
    <description>in this cohort study, we will take blood to examine the platelet function</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with overt signs of acute upper gastrointestinal bleeding (melena, coffee ground&#xD;
        or fresh hematemesis with or without circulatory instability)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with overt signs of acute upper gastrointestinal bleeding (melena, coffee&#xD;
             ground or fresh hematemesis with or without circulatory instability)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  asymptomatic patients with anemia are absence of positive gastroscopic findings to&#xD;
             support gastrointestinal bleeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Endoscopy Centre</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 21, 2020</last_update_submitted>
  <last_update_submitted_qc>January 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>James Yun-wong Lau</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Hemorrhage</mesh_term>
    <mesh_term>Hematemesis</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03028064
org study id: POCGIB
nct id: NCT03028064
lead sponsor: 
Acute upper gastrointestinal bleeding (AUGIB) is a common medical emergency. In an ageing
      population, antiplatelet drugs are increasingly being prescribed for treatment and
      prophylaxis against cardiovascular thrombo-embolic events. In many patients, platelet
      dysfunction mostly acquired is the principal cause of bleeding. To clinicians, the management
      of patients on antiplatelet drugs or anticoagulants is a challenge. One has to carefully
      balance the bleeding against thrombo-embolic risks. Therefore measuring platelet function
      should be integral in the management plan. A quantitative measurement allows titration of
      platelet function in accordance with bleeding or thromboembolic risk. Platelet function has
      not been studied in a large cohort of patients with acute upper gastrointestinal bleeding. As
      a first step, the study will determine if platelet dysfunction is associated with clinical
      outcome. In this prospective, observational single centre cohort study of consecutive
      patients with overt signs of acute upper gastrointestinal bleeding, their platelet function
      by point of care tests (light transmittance aggregometry, verify now p2y12,the platelet
      function analysis system (PFA-100) upon their admissions. Patients will be followed up for 30
      days after trial enrollment. The primary endpoint is defined as significant bleeding that
      requires interventions (endoscopic, radiologic or surgery). Secondary end points include
      cardio- and cerebrovascular thrombo-embolic events and all cause deaths. A receiver operating
      characteristic (ROC) curve analysis is calculated for each point-of-care test to evaluate if
      individual test can distinguish between patients with and without primary end point. This
      study aims to evaluate the capability of platelet function tests to predict clinical outcome
      in patients with AUGIB. Logistic regression models will then be built in search for
      independent correlates to the primary and secondary endpoints and to adjust for confounding
      variables.
observational model: Cohort
time perspective: Prospective
measure: Active bleeding that requires interventions (endoscopic, radiologic or surgery)
time frame: within 30 days of trial inclusion
description: Data on whether patients experience further bleeding that requires interventions, the type of interventions and the time of further bleeding after trial inclusion, will be collected through electronic medical record
measure: All cause deaths, cardiovascular or cerebral thrombotic events
time frame: within 30 days of trial inclusion
description: All cause deaths, cardiovascular or cerebral thrombotic events
intervention type: Other
intervention name: blood taking
description: in this cohort study, we will take blood to examine the platelet function
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: James Yun-wong Lau
investigator title: Professor
mesh term: Gastrointestinal Hemorrhage
mesh term: Hematemesis
mesh term: Hemorrhage
sharing ipd: Undecided