<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/NCT01683747</url>
  </required_header>
  <id_info>
    <org_study_id>110376</org_study_id>
    <nct_id>NCT01683747</nct_id>
  </id_info>
  <brief_title>Single Dose Enteral Tranexamic Acid in Critically Ill Patients</brief_title>
  <official_title>Single Dose Enteral Tranexamic Acid for the Reduction of Morbidity in Hospitalized Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Diego Veterans Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Inflammagen/Leading Ventures</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>San Diego Veterans Healthcare System</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The premise of this study is that enteral tranexamic acid will help to maintain small bowel&#xD;
      integrity, which is often compromised by critical illness due to inadequate cardiovascular&#xD;
      perfusion (i.e., shock), and that maintenance of small bowel integrity will decrease&#xD;
      morbidity in critically ill patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to provide preliminary efficacy and safety data on the&#xD;
      enteral administration of a one-time dose of tranexamic acid to critically ill patients for&#xD;
      the reduction of morbidity at 28 days after enrollment in the study.&#xD;
&#xD;
      Secondary objectives of this study are to determine the efficacy of administration of enteral&#xD;
      tranexamic acid in reducing intensive care unit (ICU) and hospital length-of-stay, as well&#xD;
      and mortality and morbidity at 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lower than anticipated enrollment&#xD;
  </why_stopped>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Morbidity</measure>
    <time_frame>28 days</time_frame>
    <description>Morbidity will be assessed at 28 days as measured by the validated Self-Administered Quality of Well-being Scale (QWB-SA) and 5-Point modified Oxford Handicap Scale [secondary scale]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>morbidity</measure>
    <time_frame>6 months</time_frame>
    <description>Morbidity will be assessed at 28 days as measured by the validated Self-Administered Quality of Well-being Scale (QWB-SA) and 5-Point modified Oxford Handicap Scale [secondary scale]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>28 days</time_frame>
    <description>All-cause death will be measured at 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>6 months</time_frame>
    <description>All cause mortality will be measured at 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Time spent as a patient in the ICU will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Time spent in the hospital as a patient will be measured</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Shock</condition>
  <condition>Sepsis</condition>
  <condition>Hypotension</condition>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Tranexamic acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study group receives enteral tranexamic acid in normal saline in addition to usual care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control group receives vehicle (normal saline) without study drug and usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid</intervention_name>
    <arm_group_label>Tranexamic acid</arm_group_label>
    <other_name>Cyclokapron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Control Intervention (Carrier fluid only)</intervention_name>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Critically ill patients admitted to ICU within 48 hours of onset of illness&#xD;
&#xD;
          -  Patients with feeding tubes (e.g., orogastric, nasogastric, PEG, etc.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  primary admitting diagnosis of cancer&#xD;
&#xD;
          -  primary admitting diagnosis of acute congestive heart failure&#xD;
&#xD;
          -  primary admitting diagnosis of chronic obstructive pulmonary disease (COPD)&#xD;
&#xD;
          -  primary admitting diagnosis of acute myocardial infarction or unstable cardiac&#xD;
             arrythmia&#xD;
&#xD;
          -  primary admitting diagnosis of amyotrophic lateral sclerosis (ALS) or other&#xD;
             non-infectious disease&#xD;
&#xD;
          -  primary admitting diagnosis of post-operative neurosurgical procedure&#xD;
&#xD;
          -  known hypersensitivity to tranexamic acid&#xD;
&#xD;
          -  acquired disturbances of color vision&#xD;
&#xD;
          -  hematuria cause by disease of the renal parenchyma&#xD;
&#xD;
          -  active thromboembolic disease such as deep venous thrombosis or pulmonary embolism&#xD;
&#xD;
          -  patients with known clotting disorders or other known bleeding disorders&#xD;
&#xD;
          -  recent (within 3 months) or active cerebrovascular bleed&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  inability to take study medicine (i.e., ileus with &gt; 500ml stomach residuals, NPO&#xD;
             status)&#xD;
&#xD;
          -  patients excluded at the discretion of the treating physician&#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>Erik B Kistler, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA San Diego Healthcare/University of California, San Diego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA San Diego Health Care System</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 9, 2012</study_first_submitted>
  <study_first_submitted_qc>September 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>November 16, 2015</last_update_submitted>
  <last_update_submitted_qc>November 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Diego Veterans Healthcare System</investigator_affiliation>
    <investigator_full_name>Erik B. Kistler, MD, PhD</investigator_full_name>
    <investigator_title>Principal Investigator, Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>sepsis</keyword>
  <keyword>shock</keyword>
  <keyword>placebo controlled</keyword>
  <keyword>double blinded</keyword>
  <keyword>interventional</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tranexamic Acid</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/NCT01683747
org study id: 110376
nct id: NCT01683747
lead sponsor: 
collaborator: 
has dmc: Yes
The premise of this study is that enteral tranexamic acid will help to maintain small bowel
      integrity, which is often compromised by critical illness due to inadequate cardiovascular
      perfusion (i.e., shock), and that maintenance of small bowel integrity will decrease
      morbidity in critically ill patients.
The primary objective of this study is to provide preliminary efficacy and safety data on the
      enteral administration of a one-time dose of tranexamic acid to critically ill patients for
      the reduction of morbidity at 28 days after enrollment in the study.

      Secondary objectives of this study are to determine the efficacy of administration of enteral
      tranexamic acid in reducing intensive care unit (ICU) and hospital length-of-stay, as well
      and mortality and morbidity at 6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Morbidity
time frame: 28 days
description: Morbidity will be assessed at 28 days as measured by the validated Self-Administered Quality of Well-being Scale (QWB-SA) and 5-Point modified Oxford Handicap Scale [secondary scale]
measure: morbidity
time frame: 6 months
description: Morbidity will be assessed at 28 days as measured by the validated Self-Administered Quality of Well-being Scale (QWB-SA) and 5-Point modified Oxford Handicap Scale [secondary scale]
measure: mortality
time frame: 28 days
description: All-cause death will be measured at 28 days
measure: mortality
time frame: 6 months
description: All cause mortality will be measured at 6 months
measure: ICU length of stay
time frame: up to 6 months
description: Time spent as a patient in the ICU will be measured
measure: Hospital length of stay
time frame: up to 6 months
description: Time spent in the hospital as a patient will be measured
arm group label: Tranexamic acid
arm group type: Experimental
description: Study group receives enteral tranexamic acid in normal saline in addition to usual care.
arm group label: Control group
arm group type: Placebo Comparator
description: Control group receives vehicle (normal saline) without study drug and usual care.
intervention type: Drug
intervention name: Tranexamic Acid
arm group label: Tranexamic acid
other name: Cyclokapron
intervention type: Drug
intervention name: Control Intervention (Carrier fluid only)
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Erik B Kistler, MD, PhD
role: Principal Investigator
affiliation: VA San Diego Healthcare/University of California, San Diego
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: San Diego Veterans Healthcare System
investigator full name: Erik B. Kistler, MD, PhD
investigator title: Principal Investigator, Assistant Professor
mesh term: Hypotension
mesh term: Critical Illness
mesh term: Tranexamic Acid