<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/NCT01713101</url>
  </required_header>
  <id_info>
    <org_study_id>B-1207-163-002</org_study_id>
    <nct_id>NCT01713101</nct_id>
  </id_info>
  <brief_title>Tranexamic Acid for Upper Gastrointestinal Bleeding</brief_title>
  <acronym>TAUGIB</acronym>
  <official_title>Early Administration of Intravenous Tranexamic Acid for Upper Gastrointestinal Bleeding Prior to Endoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <brief_summary>
    <textblock>
      This study is to see whether the early intravenous administration of tranexamic acid improves&#xD;
      the outcome of acute upper gastrointestinal bleeding.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies reported that IV/Oral administration of tranexamic acid improves the outcome&#xD;
      upper gastrointestinal bleeding. However, the drug is scarcely used nowadays as those studies&#xD;
      are outdated in present clinical field where early endoscopic treatment and PPI&#xD;
      administration are considered norm. Although a recent meta-analysis done by Cochrane review&#xD;
      group concluded that it improves patient survival, other review articles including &quot;Gut&quot;&#xD;
      suggested that a well-designed clinical study is needed for re-evaluation of the efficacy and&#xD;
      safety of the drug in current clinical situation. We hypothesized that early administration&#xD;
      of the drug will significantly decrease the proportion of patient requiring early endoscopic&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients requiring early endoscopic treatment</measure>
    <time_frame>Within 24 hours of emergency department visit</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Endoscopic signs of bleeding</measure>
    <time_frame>Within 24 hours of emergency department visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>Within one-month of emergency department visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for urgent endoscopy</measure>
    <time_frame>Within 24 hours of emergency department visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endoscopic procedure time/difficulty</measure>
    <time_frame>Within 24 hours of emergency department visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for transfusion</measure>
    <time_frame>Within one-month of emergency department visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for surgery/angiographic intervention</measure>
    <time_frame>Within one-month of emergency department visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of recurrent bleeding</measure>
    <time_frame>Within one-month of emergency department visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>death of any cause</measure>
    <time_frame>Within one-month of emergency department visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>thromboembolic complications</measure>
    <time_frame>Within one-month of emergency department visit</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Effect modification by hyperfibrinolysis and other coagulation related factors</measure>
    <time_frame>Variable (within 24-hour and 1-month of emergency department visit)</time_frame>
    <description>Separate analysis looking into the interaction between coagulation function and tranexamic acid effect</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">414</enrollment>
  <condition>Acute Upper Gastrointestinal Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Early intravenous tranexamic acid administration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Early intraveous administration of tranexamic acid&#xD;
(1g IV bolus over 10 minutes followed by 1g slow infusion over 8 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline (placebo) administration instead of tranexamic acid solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Early intravenous tranexamic acid administration</intervention_name>
    <description>Initial history taking and physical examination --&gt; enrollment --&gt; 1g bolus over 10 minutes followed slow infusion over 8 hours.</description>
    <arm_group_label>Early intravenous tranexamic acid administration</arm_group_label>
    <other_name>tranexamic acid administration</other_name>
    <other_name>transamine administration</other_name>
    <other_name>antifibrinolytics administration</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Chief complaint of hematemesis, melena or hematochezia&#xD;
&#xD;
          2. and objective signs of upper gastrointestinal bleeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant woman, age less than 18&#xD;
&#xD;
          2. Patients whose use of the study drug is contraindicated&#xD;
&#xD;
               -  Increased thromboembolic risk&#xD;
&#xD;
                    -  History of thromboembolic disease&#xD;
&#xD;
                    -  Alleged inherited thrombophilic disorders&#xD;
&#xD;
                    -  Malignancy (except those cured and has not recurred more than two years)&#xD;
&#xD;
                    -  Nephrotic syndrome&#xD;
&#xD;
                    -  Estrogen use&#xD;
&#xD;
                    -  Pregnancy&#xD;
&#xD;
                    -  HIT, APA&#xD;
&#xD;
               -  High-risk for cardioembolism&#xD;
&#xD;
                    -  Underlying structural heart disease where anticoagulation is indicated&#xD;
&#xD;
                    -  Underlying cardiac rhythm disorder where anticoagulation is indicated (e.g.&#xD;
                       atrial fibrillation/flutter)&#xD;
&#xD;
               -  Possibilities of ongoing DIC&#xD;
&#xD;
                    -  Signs and symptoms suggestive of clinically significant infectious disease&#xD;
                       (e.g. body temperature &gt; 38 degree)&#xD;
&#xD;
                    -  Any malignancy except those cured and has not recurred more than two years&#xD;
&#xD;
               -  Patients with history or presence of subarachnoid hemorrhage&#xD;
&#xD;
               -  Acquired color vision impairment, visual loss and retinal venous and arterial&#xD;
                  occlusions&#xD;
&#xD;
               -  Past history of seizure or organic brain lesion that predispose to seizure&#xD;
                  disorder&#xD;
&#xD;
          3. Previous history of variceal bleeding&#xD;
&#xD;
          4. Cases where informed consent is unobtainable&#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>Kyuseok Kim, MD</last_name>
    <role>Study Director</role>
    <affiliation>Professor, department of emergency medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sang Hyub Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor, department of internal medicine (gastroenterology)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cheol Min Shin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor, department of internal medicine (gastroenterology)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kyuseok Kim, MD</last_name>
    <phone>+82-31-787-7572</phone>
    <email>dremkks@snubh.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Joonghee Kim, MD</last_name>
    <phone>+82-10-9489-3696</phone>
    <email>joonghee@me.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Kyeongi-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kyuseok Kim, MD</last_name>
      <phone>+82-31-787-7572</phone>
      <email>dremkks@snubh.org</email>
    </contact>
    <contact_backup>
      <last_name>Joonghee Kim, MD</last_name>
      <phone>+82-10-9489-3696</phone>
      <email>joonghee@me.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>May 14, 2014</last_update_submitted>
  <last_update_submitted_qc>May 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastrointestinal Hemorrhage</keyword>
  <keyword>Peptic Ulcer Hemorrhage</keyword>
  <keyword>Hematemesis</keyword>
  <keyword>Melena</keyword>
  <keyword>Tranexamic acid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tranylcypromine</mesh_term>
    <mesh_term>Tranexamic Acid</mesh_term>
    <mesh_term>Antifibrinolytic Agents</mesh_term>
  </intervention_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/NCT01713101
org study id: B-1207-163-002
nct id: NCT01713101
lead sponsor: 
This study is to see whether the early intravenous administration of tranexamic acid improves
      the outcome of acute upper gastrointestinal bleeding.
Previous studies reported that IV/Oral administration of tranexamic acid improves the outcome
      upper gastrointestinal bleeding. However, the drug is scarcely used nowadays as those studies
      are outdated in present clinical field where early endoscopic treatment and PPI
      administration are considered norm. Although a recent meta-analysis done by Cochrane review
      group concluded that it improves patient survival, other review articles including "Gut"
      suggested that a well-designed clinical study is needed for re-evaluation of the efficacy and
      safety of the drug in current clinical situation. We hypothesized that early administration
      of the drug will significantly decrease the proportion of patient requiring early endoscopic
      treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Proportion of patients requiring early endoscopic treatment
time frame: Within 24 hours of emergency department visit
measure: Endoscopic signs of bleeding
time frame: Within 24 hours of emergency department visit
measure: Length of stay
time frame: Within one-month of emergency department visit
measure: Need for urgent endoscopy
time frame: Within 24 hours of emergency department visit
measure: Endoscopic procedure time/difficulty
time frame: Within 24 hours of emergency department visit
measure: Need for transfusion
time frame: Within one-month of emergency department visit
measure: Need for surgery/angiographic intervention
time frame: Within one-month of emergency department visit
measure: rate of recurrent bleeding
time frame: Within one-month of emergency department visit
measure: death of any cause
time frame: Within one-month of emergency department visit
measure: thromboembolic complications
time frame: Within one-month of emergency department visit
measure: Effect modification by hyperfibrinolysis and other coagulation related factors
time frame: Variable (within 24-hour and 1-month of emergency department visit)
description: Separate analysis looking into the interaction between coagulation function and tranexamic acid effect
arm group label: Early intravenous tranexamic acid administration
arm group type: Experimental
description: Early intraveous administration of tranexamic acid
(1g IV bolus over 10 minutes followed by 1g slow infusion over 8 hours
arm group label: Placebo group
arm group type: Placebo Comparator
description: Normal saline (placebo) administration instead of tranexamic acid solution
intervention type: Drug
intervention name: Early intravenous tranexamic acid administration
description: Initial history taking and physical examination --> enrollment --> 1g bolus over 10 minutes followed slow infusion over 8 hours.
arm group label: Early intravenous tranexamic acid administration
other name: tranexamic acid administration
other name: transamine administration
other name: antifibrinolytics administration
intervention type: Drug
intervention name: placebo
arm group label: Placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kyuseok Kim, MD
role: Study Director
affiliation: Professor, department of emergency medicine
last name: Sang Hyub Lee, MD
role: Principal Investigator
affiliation: Professor, department of internal medicine (gastroenterology)
last name: Cheol Min Shin, MD
role: Principal Investigator
affiliation: Professor, department of internal medicine (gastroenterology)
last name: Kyuseok Kim, MD
phone: +82-31-787-7572
email: dremkks@snubh.org
last name: Joonghee Kim, MD
phone: +82-10-9489-3696
email: joonghee@me.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Gastrointestinal Hemorrhage
mesh term: Hemorrhage
mesh term: Tranylcypromine
mesh term: Tranexamic Acid
mesh term: Antifibrinolytic Agents