<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/NCT01675856</url>
  </required_header>
  <id_info>
    <org_study_id>AUGIB</org_study_id>
    <nct_id>NCT01675856</nct_id>
  </id_info>
  <brief_title>Urgent vs. Early Endoscopy in High Risk Patients With Upper Gastrointestinal Bleeding (UGIB)</brief_title>
  <official_title>Urgent vs. Early Endoscopy in High Risk Patients With UGIB</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>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute upper gastrointestinal bleeding (UGIB) is one of the commonest medical emergencies. The&#xD;
      condition accounts for 150 per 100,000 populations. A National United Kingdom reported a&#xD;
      crude overall mortality rate of 10%. While bleeding stops spontaneously in majority of&#xD;
      patients at their presentation, there remains a subgroup of patients who continue to bleed or&#xD;
      develop recurrent bleeding. In these patients, the mortality increases manifolds. If these&#xD;
      high-risk patients can be identified, early interventions may improve their outcomes.&#xD;
&#xD;
      Several prognostic indices are in use for the purpose of patient stratification. They include&#xD;
      the Rockall, Glasgow-Blatchford (GBS) and the Baylor scores. The Rockall score is a composite&#xD;
      score which incorporates clinical parameters as well as findings during endoscopy which was&#xD;
      derived to predict mortality. The GBS is a pre-endoscopy or a clinical score for the&#xD;
      prediction for the need of further intervention loosely defined as the need for transfusion,&#xD;
      endoscopy or surgery. It has been shown to be accurate in identifying low risk patients for&#xD;
      early discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The GBS, being a pre-endoscopy score with clinical parameters, is more suitable for patient&#xD;
      triage leading to urgent endoscopy and a higher level of care. A GBS of 0 has been shown to&#xD;
      identify patients with upper gastrointestinal bleeding who may be managed safely as&#xD;
      outpatients. The proportion of patients requiring endoscopic therapy increases with a higher&#xD;
      score. A cut-off score that identifies &quot;high-risk&quot; patients who may benefit from urgent&#xD;
      intervention however has not been determined. Guidelines from Societies around the world&#xD;
      recommend early endoscopy within 24 hours of presentation for acute upper gastrointestinal&#xD;
      bleeding (AUGIB). The guidelines also state that a proportion of patients need emergency&#xD;
      &quot;out-of-hours&quot; endoscopy, without defining the &quot;high-risk&quot; group. A recent international&#xD;
      consensus on the management of NVUGIB recommended early endoscopy within 24 hours for&#xD;
      Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB), and noted no additional benefit&#xD;
      associated with urgent endoscopy (&lt;12 hours) vs. early endoscopy (&gt;12 hours) in unselected&#xD;
      patients with NVUGIB. However, there are only limited data on the role of urgent endoscopy in&#xD;
      the &quot;selected&quot; subgroup of patients with high-risk NVUGIB.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2012</start_date>
  <completion_date type="Actual">November 11, 2018</completion_date>
  <primary_completion_date type="Actual">November 11, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients are randomized in a 1:1 ratio. The patient is randomized to receive;&#xD;
Urgent endoscopy (defined by endoscopy within 6 hours from first consultation by GI specialists at PWH) or&#xD;
Early endoscopy (defined by endoscopy next morning and within 24 hours from first consultation by GI specialists at PWH)</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Death from all causes 30 days from randomization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Need for endoscopic therapy at index endoscopy</measure>
    <time_frame>At the time of index endoscopy</time_frame>
    <description>To measure if endoscopic therapy is needed at the index endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for transfusion</measure>
    <time_frame>Within 30days of randomization</time_frame>
    <description>To measure if transfusion of blood products is needed within 30days of randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrent bleeding as defined</measure>
    <time_frame>Within 30days of randomization</time_frame>
    <description>To measure if any clinical or endoscopic recurrent bleeding is identified.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay of index bleeding</measure>
    <time_frame>Within 30 days of randomization</time_frame>
    <description>To measure the number of days of hospital stay upon randomization, only counted the hospitalization days of index bleeding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU stay</measure>
    <time_frame>Within 30days of randomization</time_frame>
    <description>To measure if ICU admission is required at the index bleeding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for further endoscopic treatment</measure>
    <time_frame>Within 30days of randomization</time_frame>
    <description>To measure if further endoscopic treatment if required at recurrent bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency surgery or interventional radiology to achieve hemostasis</measure>
    <time_frame>Within 30days of randomization</time_frame>
    <description>To measure if emergency surgery or interventional radiology is needed at index bleeding or recurrent bleeding to achieve hemostasis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of recurrent bleeding</measure>
    <time_frame>Within 30 days of randomization</time_frame>
    <description>To measure recurrent bleeding in both study arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of adverse events</measure>
    <time_frame>Within 30 days of randomization</time_frame>
    <description>To measure the adverse events in either group, e.g. myocardial event, cerebrovascular event and acute renal failure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">516</enrollment>
  <condition>Bleeding Peptic Ulcer</condition>
  <condition>Active Bleeding</condition>
  <condition>Gastrointestinal Bleeding</condition>
  <arm_group>
    <arm_group_label>Urgent endoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oesophagogastroduodenoscopy done within 6hours of first GI specialists consultation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early endoscopy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oesophagogastroduodenoscopy done within 24hours of first GI specialists consultation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Urgent endoscopy</intervention_name>
    <description>Defined by oesophagogastroduodenoscopy within 6 hours of first presentation of Prince of Wales Hospital</description>
    <arm_group_label>Urgent endoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early endoscopy</intervention_name>
    <description>Defined by oesophagogastroduodenoscopy within 24 hours of first presentation of Prince of Wales Hospital</description>
    <arm_group_label>Early endoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Overt signs of upper gastrointestinal bleeding (i.e., melena or hematemesis with or&#xD;
             without hypotension)&#xD;
&#xD;
          2. GBS of ≥12&#xD;
&#xD;
          3. In-patients admitted for reasons other than AUGIB who develop bleeding are also&#xD;
             considered for trial enrollment.&#xD;
&#xD;
          4. Patients in Hypotensive shock (SBP ≤90 mmHg or pulse ≥110 bpm) are initially&#xD;
             resuscitated and then considered for trial entry if their condition can be stabilized.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. continued shock despite initial volume resuscitation (refractory shock) undergo urgent&#xD;
             endoscopy&#xD;
&#xD;
          2. &lt; 18 years of age&#xD;
&#xD;
          3. Unable to provide written informed consent&#xD;
&#xD;
          4. Pregnant or lactating women&#xD;
&#xD;
          5. Moribund patients from terminal illnesses. (active treatment not considered)&#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>James Y LAU, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Endoscopy Centre, Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</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>
  <keyword>Glasgow-Blatchford score</keyword>
  <keyword>Gastrointestinal bleeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Hemorrhage</mesh_term>
    <mesh_term>Peptic Ulcer</mesh_term>
    <mesh_term>Peptic Ulcer Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT01675856
org study id: AUGIB
nct id: NCT01675856
lead sponsor: 
has dmc: No
Acute upper gastrointestinal bleeding (UGIB) is one of the commonest medical emergencies. The
      condition accounts for 150 per 100,000 populations. A National United Kingdom reported a
      crude overall mortality rate of 10%. While bleeding stops spontaneously in majority of
      patients at their presentation, there remains a subgroup of patients who continue to bleed or
      develop recurrent bleeding. In these patients, the mortality increases manifolds. If these
      high-risk patients can be identified, early interventions may improve their outcomes.

      Several prognostic indices are in use for the purpose of patient stratification. They include
      the Rockall, Glasgow-Blatchford (GBS) and the Baylor scores. The Rockall score is a composite
      score which incorporates clinical parameters as well as findings during endoscopy which was
      derived to predict mortality. The GBS is a pre-endoscopy or a clinical score for the
      prediction for the need of further intervention loosely defined as the need for transfusion,
      endoscopy or surgery. It has been shown to be accurate in identifying low risk patients for
      early discharge.
The GBS, being a pre-endoscopy score with clinical parameters, is more suitable for patient
      triage leading to urgent endoscopy and a higher level of care. A GBS of 0 has been shown to
      identify patients with upper gastrointestinal bleeding who may be managed safely as
      outpatients. The proportion of patients requiring endoscopic therapy increases with a higher
      score. A cut-off score that identifies "high-risk" patients who may benefit from urgent
      intervention however has not been determined. Guidelines from Societies around the world
      recommend early endoscopy within 24 hours of presentation for acute upper gastrointestinal
      bleeding (AUGIB). The guidelines also state that a proportion of patients need emergency
      "out-of-hours" endoscopy, without defining the "high-risk" group. A recent international
      consensus on the management of NVUGIB recommended early endoscopy within 24 hours for
      Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB), and noted no additional benefit
      associated with urgent endoscopy (<12 hours) vs. early endoscopy (>12 hours) in unselected
      patients with NVUGIB. However, there are only limited data on the role of urgent endoscopy in
      the "selected" subgroup of patients with high-risk NVUGIB.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients are randomized in a 1:1 ratio. The patient is randomized to receive;
Urgent endoscopy (defined by endoscopy within 6 hours from first consultation by GI specialists at PWH) or
Early endoscopy (defined by endoscopy next morning and within 24 hours from first consultation by GI specialists at PWH)
primary purpose: Diagnostic
masking: None (Open Label)
measure: Mortality
time frame: 30 days
description: Death from all causes 30 days from randomization
measure: Need for endoscopic therapy at index endoscopy
time frame: At the time of index endoscopy
description: To measure if endoscopic therapy is needed at the index endoscopy
measure: Need for transfusion
time frame: Within 30days of randomization
description: To measure if transfusion of blood products is needed within 30days of randomization
measure: Recurrent bleeding as defined
time frame: Within 30days of randomization
description: To measure if any clinical or endoscopic recurrent bleeding is identified.
measure: Duration of hospital stay of index bleeding
time frame: Within 30 days of randomization
description: To measure the number of days of hospital stay upon randomization, only counted the hospitalization days of index bleeding.
measure: ICU stay
time frame: Within 30days of randomization
description: To measure if ICU admission is required at the index bleeding.
measure: Need for further endoscopic treatment
time frame: Within 30days of randomization
description: To measure if further endoscopic treatment if required at recurrent bleeding
measure: Emergency surgery or interventional radiology to achieve hemostasis
time frame: Within 30days of randomization
description: To measure if emergency surgery or interventional radiology is needed at index bleeding or recurrent bleeding to achieve hemostasis
measure: Rates of recurrent bleeding
time frame: Within 30 days of randomization
description: To measure recurrent bleeding in both study arms
measure: Rate of adverse events
time frame: Within 30 days of randomization
description: To measure the adverse events in either group, e.g. myocardial event, cerebrovascular event and acute renal failure.
arm group label: Urgent endoscopy
arm group type: Active Comparator
description: Oesophagogastroduodenoscopy done within 6hours of first GI specialists consultation
arm group label: Early endoscopy
arm group type: Placebo Comparator
description: Oesophagogastroduodenoscopy done within 24hours of first GI specialists consultation
intervention type: Other
intervention name: Urgent endoscopy
description: Defined by oesophagogastroduodenoscopy within 6 hours of first presentation of Prince of Wales Hospital
arm group label: Urgent endoscopy
intervention type: Other
intervention name: Early endoscopy
description: Defined by oesophagogastroduodenoscopy within 24 hours of first presentation of Prince of Wales Hospital
arm group label: Early endoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James Y LAU, MD
role: Principal Investigator
affiliation: Chinese University of Hong Kong
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: Peptic Ulcer
mesh term: Peptic Ulcer Hemorrhage
mesh term: Hemorrhage
sharing ipd: No