<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/NCT04499274</url>
  </required_header>
  <id_info>
    <org_study_id>B-2008/631-305</org_study_id>
    <nct_id>NCT04499274</nct_id>
  </id_info>
  <brief_title>Ondansetron and Blood Coagulation</brief_title>
  <official_title>The Effect of an Ondansetron on Blood Coagulation: In Vitro, Volunteer Study Using Rotational Thromboelastometry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Bundang Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ondansetron may alter whole blood coagulation. However, little is known about the&#xD;
      dose-response relationships according to the blood concentration of ondansetron. The&#xD;
      investigators therefore will perform the present study to measure the effect of ondansestron&#xD;
      on the blood coagulation pathway according to the drug concentration level using a&#xD;
      thromboelastography test.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 16, 2020</start_date>
  <completion_date type="Anticipated">December 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 15, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Citrated Functional Fibrinogen</measure>
    <time_frame>During the thromboelastography analysis/ an average of 1 hour</time_frame>
    <description>Provides clot strength based on fibrinogen contribution</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Citrated Kaolin</measure>
    <time_frame>During the thromboelastography analysis/ an average of 1 hour</time_frame>
    <description>Normal thromboelastography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Citrated Kaolin Heparinase</measure>
    <time_frame>During the thromboelastography analysis/ an average of 1 hour</time_frame>
    <description>To assess the effect of heparin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Citrated Rapid Thromboelastography</measure>
    <time_frame>During the thromboelastography analysis/ an average of 1 hour</time_frame>
    <description>A quicker assessment of clot strength, without assessment of clot initiation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heparinized Kaolin Heparinase</measure>
    <time_frame>During the thromboelastography analysis/ an average of 1 hour</time_frame>
    <description>To measure the platelet function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activator F</measure>
    <time_frame>During the thromboelastography analysis/ an average of 1 hour</time_frame>
    <description>To eliminate the platelet function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adenosine diphosphate</measure>
    <time_frame>During the thromboelastography analysis/ an average of 1 hour</time_frame>
    <description>To masure the drug effect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arachidonic acid</measure>
    <time_frame>During the thromboelastography analysis/ an average of 1 hour</time_frame>
    <description>To masure the drug effect</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Blood Coagulation Disorder</condition>
  <arm_group>
    <arm_group_label>0 ng/ml</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blood specimen which was added 0 ul of ondansetron</description>
  </arm_group>
  <arm_group>
    <arm_group_label>200 ng/ml</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blood specimen which was added 0.20 ul of ondansetron</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2000 ng/ml</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blood specimen which was added 2 ul of ondansetron</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20000 ng/ml</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blood specimen which was added 20 ul of ondansetron</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0 ul of ondansetron</intervention_name>
    <description>Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 nl) using ondansetron</description>
    <arm_group_label>0 ng/ml</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.2 ul of ondansetron</intervention_name>
    <description>Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.2 ul) using ondansetron</description>
    <arm_group_label>200 ng/ml</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2 ul of ondansetron</intervention_name>
    <description>Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (2 ul) using ondansetron</description>
    <arm_group_label>2000 ng/ml</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>20 ul of ondansetron</intervention_name>
    <description>Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (20 ul) using ondansetron</description>
    <arm_group_label>20000 ng/ml</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy vonlunteers&#xD;
&#xD;
          -  Age: 20 to 65 years&#xD;
&#xD;
          -  Body weight &gt; 50 kg&#xD;
&#xD;
          -  Volunteers who provided informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hematologic disease&#xD;
&#xD;
          -  Anticoagulant medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyo-Seok Na, MD., PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hyo-Seok Na, MD., PhD.</last_name>
    <phone>82317877507</phone>
    <email>hsknana@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National Univ. Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggi</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hyo-Seok Na</last_name>
      <phone>1087012913</phone>
      <email>hsknana@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Hyo-Seok Na</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ondansetron</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/NCT04499274
org study id: B-2008/631-305
nct id: NCT04499274
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ondansetron may alter whole blood coagulation. However, little is known about the
      dose-response relationships according to the blood concentration of ondansetron. The
      investigators therefore will perform the present study to measure the effect of ondansestron
      on the blood coagulation pathway according to the drug concentration level using a
      thromboelastography test.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Citrated Functional Fibrinogen
time frame: During the thromboelastography analysis/ an average of 1 hour
description: Provides clot strength based on fibrinogen contribution
measure: Citrated Kaolin
time frame: During the thromboelastography analysis/ an average of 1 hour
description: Normal thromboelastography
measure: Citrated Kaolin Heparinase
time frame: During the thromboelastography analysis/ an average of 1 hour
description: To assess the effect of heparin
measure: Citrated Rapid Thromboelastography
time frame: During the thromboelastography analysis/ an average of 1 hour
description: A quicker assessment of clot strength, without assessment of clot initiation
measure: Heparinized Kaolin Heparinase
time frame: During the thromboelastography analysis/ an average of 1 hour
description: To measure the platelet function
measure: Activator F
time frame: During the thromboelastography analysis/ an average of 1 hour
description: To eliminate the platelet function
measure: Adenosine diphosphate
time frame: During the thromboelastography analysis/ an average of 1 hour
description: To masure the drug effect
measure: Arachidonic acid
time frame: During the thromboelastography analysis/ an average of 1 hour
description: To masure the drug effect
arm group label: 0 ng/ml
arm group type: Experimental
description: Blood specimen which was added 0 ul of ondansetron
arm group label: 200 ng/ml
arm group type: Experimental
description: Blood specimen which was added 0.20 ul of ondansetron
arm group label: 2000 ng/ml
arm group type: Experimental
description: Blood specimen which was added 2 ul of ondansetron
arm group label: 20000 ng/ml
arm group type: Experimental
description: Blood specimen which was added 20 ul of ondansetron
intervention type: Drug
intervention name: 0 ul of ondansetron
description: Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 nl) using ondansetron
arm group label: 0 ng/ml
intervention type: Drug
intervention name: 0.2 ul of ondansetron
description: Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.2 ul) using ondansetron
arm group label: 200 ng/ml
intervention type: Drug
intervention name: 2 ul of ondansetron
description: Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (2 ul) using ondansetron
arm group label: 2000 ng/ml
intervention type: Drug
intervention name: 20 ul of ondansetron
description: Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (20 ul) using ondansetron
arm group label: 20000 ng/ml
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hyo-Seok Na, MD., PhD.
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
last name: Hyo-Seok Na, MD., PhD.
phone: 82317877507
email: hsknana@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Hyo-Seok Na
investigator title: Professor
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
mesh term: Ondansetron