<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/NCT02245802</url>
  </required_header>
  <id_info>
    <org_study_id>CRE-2010.207</org_study_id>
    <nct_id>NCT02245802</nct_id>
  </id_info>
  <brief_title>Multicenter Validation on Predicting Mortality for Patients With Bleeding Peptic Ulcers</brief_title>
  <official_title>Multicenter Prospective Validation Study on the Prediction of In-hospital Mortality Using CU Prediction Model for Patients With Bleeding Peptic Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tokyo University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tsuyama Central Hospital, Okayama</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hiroshima City Asa Hospital, Hiroshima</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mitoyo General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Okayama University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to validate CU prediction model on mortality for patients with high risk&#xD;
      bleeding peptic ulcers after therapeutic endoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite advances in management of patients with bleeding peptic ulcers, mortality is still&#xD;
      10%. We previously reported a prediction score for ulcer bleeding related mortality developed&#xD;
      from a local cohort. The risk factors for mortality included patients older than 70, presence&#xD;
      of co-morbidity, more than one listed co-morbidity, hematemesis, SBP &lt; 100 mmHg, in-hospital&#xD;
      bleeding, rebleeding, and need for surgery.&#xD;
&#xD;
      Study objective This study aimed to validate the prediction of mortality among patients with&#xD;
      bleeding peptic ulcers from different Asian countries.&#xD;
&#xD;
      Method Consecutive patients with bleeding peptic ulcers who presented to the study centers in&#xD;
      Hong Kong, Japan and Taiwan were recruited after successful primary endoscopic hemostasis.&#xD;
      The baseline demographics, ulcer characteristics, the predictive factors, 30 days mortality,&#xD;
      rebleeding, hospital stay and need of surgery were recorded. The accuracy of prediction for&#xD;
      adverse events including mortality and rebleeding with the prediction risk scoring system&#xD;
      would be analysed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</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>Accuracy in prediction of peptic ulcer bleeding related mortality</measure>
    <time_frame>30 days</time_frame>
    <description>The CU prediction score would be calculated from addition of all the risk factors scores. . The calculated predictive score collected from the whole group of patients would be analyzed using the receiver operating characteristic (ROC) curve and represented using the area under curve (AUC). An AUC of 0.5 would be interpreted as poor predictive power whereas a value of 1.0 would indicate excellent predictive power.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality difference between high risk and low risk group</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need of Surgery</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need of Transfusion</measure>
    <time_frame>30 days</time_frame>
    <description>Need of transfusion as represented by number of units transfused</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">785</enrollment>
  <condition>Bleeding Peptic Ulcer</condition>
  <arm_group>
    <arm_group_label>Low risk group</arm_group_label>
    <description>CU Prediction model &lt; 3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High risk group</arm_group_label>
    <description>CU Prediction model &gt;=3</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with bleeding peptic ulcers who required endoscopic therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients presented with bleeding peptic ulcers&#xD;
&#xD;
          2. Age &gt; 18 year old&#xD;
&#xD;
          3. Informed consent for the study and OGD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable or refuse to give consent&#xD;
&#xD;
          2. Onset more than 7 days&#xD;
&#xD;
          3. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip Chiu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Surgery, The Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Combined Endoscopy Center, Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong SAR</city>
        <zip>00000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Chiu PW, Ng EK, Cheung FK, Chan FK, Leung WK, Wu JC, Wong VW, Yung MY, Tsoi K, Lau JY, Sung JJ, Chung SS. Predicting mortality in patients with bleeding peptic ulcers after therapeutic endoscopy. Clin Gastroenterol Hepatol. 2009 Mar;7(3):311-6; quiz 253. doi: 10.1016/j.cgh.2008.08.044. Epub 2008 Sep 13.</citation>
    <PMID>18955161</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>September 19, 2014</last_update_submitted>
  <last_update_submitted_qc>September 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 22, 2014</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>Philip Wai Yan Chiu</investigator_full_name>
    <investigator_title>Professor, Department of Surgery, Institute of Digestive Disease</investigator_title>
  </responsible_party>
  <keyword>Bleeding peptic ulcer</keyword>
  <keyword>Prediction model</keyword>
  <keyword>Mortality</keyword>
  <keyword>Prediction of in-hospital mortality for bleeding peptic ulcer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peptic Ulcer</mesh_term>
    <mesh_term>Peptic Ulcer Hemorrhage</mesh_term>
    <mesh_term>Ulcer</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/NCT02245802
org study id: CRE-2010.207
nct id: NCT02245802
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This study aimed to validate CU prediction model on mortality for patients with high risk
      bleeding peptic ulcers after therapeutic endoscopy.
Despite advances in management of patients with bleeding peptic ulcers, mortality is still
      10%. We previously reported a prediction score for ulcer bleeding related mortality developed
      from a local cohort. The risk factors for mortality included patients older than 70, presence
      of co-morbidity, more than one listed co-morbidity, hematemesis, SBP < 100 mmHg, in-hospital
      bleeding, rebleeding, and need for surgery.

      Study objective This study aimed to validate the prediction of mortality among patients with
      bleeding peptic ulcers from different Asian countries.

      Method Consecutive patients with bleeding peptic ulcers who presented to the study centers in
      Hong Kong, Japan and Taiwan were recruited after successful primary endoscopic hemostasis.
      The baseline demographics, ulcer characteristics, the predictive factors, 30 days mortality,
      rebleeding, hospital stay and need of surgery were recorded. The accuracy of prediction for
      adverse events including mortality and rebleeding with the prediction risk scoring system
      would be analysed.
observational model: Cohort
time perspective: Prospective
measure: Accuracy in prediction of peptic ulcer bleeding related mortality
time frame: 30 days
description: The CU prediction score would be calculated from addition of all the risk factors scores. . The calculated predictive score collected from the whole group of patients would be analyzed using the receiver operating characteristic (ROC) curve and represented using the area under curve (AUC). An AUC of 0.5 would be interpreted as poor predictive power whereas a value of 1.0 would indicate excellent predictive power.
measure: Mortality difference between high risk and low risk group
time frame: 30 days
measure: Need of Surgery
time frame: 30 days
measure: Need of Transfusion
time frame: 30 days
description: Need of transfusion as represented by number of units transfused
measure: Complication rate
time frame: 30 days
measure: Hospital stay
time frame: 30 days
arm group label: Low risk group
description: CU Prediction model < 3
arm group label: High risk group
description: CU Prediction model >=3
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philip Chiu, MD
role: Principal Investigator
affiliation: Department of Surgery, The Chinese University of Hong Kong
facility: 
country: China
citation: Chiu PW, Ng EK, Cheung FK, Chan FK, Leung WK, Wu JC, Wong VW, Yung MY, Tsoi K, Lau JY, Sung JJ, Chung SS. Predicting mortality in patients with bleeding peptic ulcers after therapeutic endoscopy. Clin Gastroenterol Hepatol. 2009 Mar;7(3):311-6; quiz 253. doi: 10.1016/j.cgh.2008.08.044. Epub 2008 Sep 13.
PMID: 18955161
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Philip Wai Yan Chiu
investigator title: Professor, Department of Surgery, Institute of Digestive Disease
mesh term: Peptic Ulcer
mesh term: Peptic Ulcer Hemorrhage
mesh term: Ulcer
mesh term: Hemorrhage