<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/NCT02219152</url>
  </required_header>
  <id_info>
    <org_study_id>0321-14</org_study_id>
    <nct_id>NCT02219152</nct_id>
  </id_info>
  <brief_title>Topical Instillation of Tranexamic Aacid in Bronchoscopy to Decrease Bleeding During Entobronchial &amp; Transbronchial Biopsiy: a Prospective Double Blind Placebo Controlled Study</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liran Levy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hadassah Medical Organization</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bleeding during transbronchial ro endobronchial biopsy is rather a common complication.&#xD;
&#xD;
      Mostly this is an insignificant bleeding, but in 3% of the biopsies there is a substantial&#xD;
      amount of bleeding that requires a special treatment or follow up.&#xD;
&#xD;
      The goal of this study is to examine whether submission of tranexamic acid during the biopsy&#xD;
      could diminish the amount of bleeding.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2020</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>amount of bleeding</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of one day</time_frame>
    <description>amount of bleedibg that will be calculated on the basis of the difference between the amount of saline that will be injected at the bronchoscopy and the blood and fluid that will be collected in the suction tank.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>amount of erythrocytes</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of one day</time_frame>
    <description>amount of erythrocytes by multiplying the Hematocrit and blood volume</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Bronchoscopy Biopsy</condition>
  <arm_group>
    <arm_group_label>tranexamic acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tranexamic acid will be administrated using the bronchoscope</description>
  </arm_group>
  <arm_group>
    <arm_group_label>saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>the saline will be administrated using an infusion during the biopsy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tranexamic acid</intervention_name>
    <arm_group_label>tranexamic acid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>saline</intervention_name>
    <arm_group_label>saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient that are candidates to endobronchial or transcronchial biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  S/P MI or CVA or PE or DVT .&#xD;
&#xD;
          -  S/P thrombophilia.&#xD;
&#xD;
          -  Patients under coagulation therpay&#xD;
&#xD;
          -  Chronic Renal Failure&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neville Berkman, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hadassah Medical Organization</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liran Levy, MD</last_name>
    <phone>6475189676</phone>
    <email>dlev330@hadassah.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Liran Levy, MD</last_name>
    <phone>6475189676</phone>
    <email>levyliran361@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hadassah Medical Organization</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liran Levy, MD</last_name>
      <phone>6475189676</phone>
      <email>dlev330@hadassah.org.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>May 30, 2018</last_update_submitted>
  <last_update_submitted_qc>May 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hadassah Medical Organization</investigator_affiliation>
    <investigator_full_name>Liran Levy</investigator_full_name>
    <investigator_title>Topical Instillation of Tranexamic Aacid in Bronchoscopy to Decrease Bleeding During Entobronchial &amp; Transbronchial Biopsiy: a Prospective Double Blind Placebo Controlled Study</investigator_title>
  </responsible_party>
  <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/NCT02219152
org study id: 0321-14
nct id: NCT02219152
lead sponsor: 
has dmc: No
Bleeding during transbronchial ro endobronchial biopsy is rather a common complication.

      Mostly this is an insignificant bleeding, but in 3% of the biopsies there is a substantial
      amount of bleeding that requires a special treatment or follow up.

      The goal of this study is to examine whether submission of tranexamic acid during the biopsy
      could diminish the amount of bleeding.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: amount of bleeding
time frame: participants will be followed for the duration of hospital stay, an expected average of one day
description: amount of bleedibg that will be calculated on the basis of the difference between the amount of saline that will be injected at the bronchoscopy and the blood and fluid that will be collected in the suction tank.
measure: amount of erythrocytes
time frame: participants will be followed for the duration of hospital stay, an expected average of one day
description: amount of erythrocytes by multiplying the Hematocrit and blood volume
arm group label: tranexamic acid
arm group type: Experimental
description: tranexamic acid will be administrated using the bronchoscope
arm group label: saline
arm group type: Placebo Comparator
description: the saline will be administrated using an infusion during the biopsy.
intervention type: Drug
intervention name: tranexamic acid
arm group label: tranexamic acid
intervention type: Drug
intervention name: saline
arm group label: saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Neville Berkman, MD
role: Study Director
affiliation: Hadassah Medical Organization
last name: Liran Levy, MD
phone: 6475189676
email: dlev330@hadassah.org.il
last name: Liran Levy, MD
phone: 6475189676
email: levyliran361@gmail.com
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor-Investigator
investigator affiliation: Hadassah Medical Organization
investigator full name: Liran Levy
investigator title: Topical Instillation of Tranexamic Aacid in Bronchoscopy to Decrease Bleeding During Entobronchial & Transbronchial Biopsiy: a Prospective Double Blind Placebo Controlled Study
mesh term: Tranexamic Acid