<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/NCT03838328</url>
  </required_header>
  <id_info>
    <org_study_id>Dose effect of TA on DVT</org_study_id>
    <nct_id>NCT03838328</nct_id>
  </id_info>
  <brief_title>Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery</brief_title>
  <official_title>Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery With Cardiopulmonary Bypass</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SHI Jia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese Academy of Medical Sciences, Fuwai Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In recent years, the lysine analogs tranexamic acid (TXA) has gained wide use in cardiac&#xD;
      surgery as a blood-sparing agent. However, the safety of the drug and its impact on overall&#xD;
      outcomes of cardiac surgery remains debated. The current study evaluates the dose effect of&#xD;
      TXA on the incidence of deep venous thrombus (DVT) in cardiac surgery with cardiopulmonary&#xD;
      bypass. Also, the dose effect of TXA on bleeding and allogeneic transfusion is evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2020</primary_completion_date>
  <phase>Phase 4</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>
    <masking_description>The allocation is masked for the participant, care provider, investigator and outcomes assessor.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of deep venous thrombosis</measure>
    <time_frame>Within 7 days postoperatively</time_frame>
    <description>Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The rate of new-onset thrombotic events</measure>
    <time_frame>Within 90 days postoperatively</time_frame>
    <description>Thrombotic events include ischemic stroke, renal failure, myocardial infarction and pulmonary embolism</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The rate of allogeneic RBC transfusion</measure>
    <time_frame>Within 30 days postoperatively</time_frame>
    <description>Allogeneic blood product includes packed red blood cell</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The volume of allogeneic RBC transfusion</measure>
    <time_frame>Within 30 days postoperatively</time_frame>
    <description>Allogeneic blood product includes packed red blood cell</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in ICU and hospital</measure>
    <time_frame>Within 90 days postoperatively</time_frame>
    <description>The time interval between the end of the operation and the discharge from ICU or the hospital.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Thromboses, Deep Vein</condition>
  <condition>Tranexamic Acid Adverse Reaction</condition>
  <arm_group>
    <arm_group_label>Dose group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The dose regimen of tranexamic acid in group 1 includes a loading dose of 30mg/kg before skin incision and a maintenance dose of 20mg/kg/hr until the end of the operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The dose regimen of tranexamic acid in group 2 includes a loading dose of 20mg/kg before skin incision and a maintenance dose of 15mg/kg/hr until the end of the operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose group 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The dose regimen of tranexamic acid in group 3 includes a loading dose of 10mg/kg before skin incision and a maintenance dose of 10mg/kg/hr until the end of the operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid</intervention_name>
    <description>Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.</description>
    <arm_group_label>Dose group 1</arm_group_label>
    <arm_group_label>Dose group 2</arm_group_label>
    <arm_group_label>Dose group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients receiving selective cardiac surgery with cardiopulmonary bypass due to&#xD;
             coronary, valvular or congenital heart disease&#xD;
&#xD;
          -  Written consent obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy or contraindication to tranexamic acid&#xD;
&#xD;
          -  Severe renal impairment (serum creatinine &gt;250 μmol/l, or estimated creatinine&#xD;
             clearance &lt;25 ml/min)&#xD;
&#xD;
          -  Thromboembolic disease including but not limited to: history of pulmonary embolism,&#xD;
             spontaneous arterial thrombosis or familial hypercoaguability (eg. Lupus&#xD;
             anticoagulant, protein C deficiency)&#xD;
&#xD;
          -  Thrombocytopenia defined as a platelet count &lt;100,000/ml&#xD;
&#xD;
          -  Coagulopathy defined as an international normalized ratio &gt; 1.5 prior to surgery&#xD;
&#xD;
          -  Currently enrolled in another perioperative interventional study&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jia Shi, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fuwai Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jia Shi, M.D.</last_name>
    <phone>86 10 88322467</phone>
    <email>shiandypumc@sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese Academy of Medical Sciences， Fuwai Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100037</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 9, 2019</last_update_submitted>
  <last_update_submitted_qc>February 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Academy of Medical Sciences, Fuwai Hospital</investigator_affiliation>
    <investigator_full_name>SHI Jia</investigator_full_name>
    <investigator_title>Associate Professor and Vice Chair of the Anesthesiology Department</investigator_title>
  </responsible_party>
  <keyword>dose effect</keyword>
  <keyword>tranexamic acid</keyword>
  <keyword>deep vein thromboses</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</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>
  <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/NCT03838328
org study id: Dose effect of TA on DVT
nct id: NCT03838328
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
In recent years, the lysine analogs tranexamic acid (TXA) has gained wide use in cardiac
      surgery as a blood-sparing agent. However, the safety of the drug and its impact on overall
      outcomes of cardiac surgery remains debated. The current study evaluates the dose effect of
      TXA on the incidence of deep venous thrombus (DVT) in cardiac surgery with cardiopulmonary
      bypass. Also, the dose effect of TXA on bleeding and allogeneic transfusion is evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The allocation is masked for the participant, care provider, investigator and outcomes assessor.
measure: The incidence of deep venous thrombosis
time frame: Within 7 days postoperatively
description: Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound
measure: The rate of new-onset thrombotic events
time frame: Within 90 days postoperatively
description: Thrombotic events include ischemic stroke, renal failure, myocardial infarction and pulmonary embolism
measure: The rate of allogeneic RBC transfusion
time frame: Within 30 days postoperatively
description: Allogeneic blood product includes packed red blood cell
measure: The volume of allogeneic RBC transfusion
time frame: Within 30 days postoperatively
description: Allogeneic blood product includes packed red blood cell
measure: Length of stay in ICU and hospital
time frame: Within 90 days postoperatively
description: The time interval between the end of the operation and the discharge from ICU or the hospital.
arm group label: Dose group 1
arm group type: Experimental
description: The dose regimen of tranexamic acid in group 1 includes a loading dose of 30mg/kg before skin incision and a maintenance dose of 20mg/kg/hr until the end of the operation.
arm group label: Dose group 2
arm group type: Experimental
description: The dose regimen of tranexamic acid in group 2 includes a loading dose of 20mg/kg before skin incision and a maintenance dose of 15mg/kg/hr until the end of the operation.
arm group label: Dose group 3
arm group type: Active Comparator
description: The dose regimen of tranexamic acid in group 3 includes a loading dose of 10mg/kg before skin incision and a maintenance dose of 10mg/kg/hr until the end of the operation.
intervention type: Drug
intervention name: Tranexamic Acid
description: Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.
arm group label: Dose group 1
arm group label: Dose group 2
arm group label: Dose group 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jia Shi, M.D.
role: Principal Investigator
affiliation: Fuwai Hospital
last name: Jia Shi, M.D.
phone: 86 10 88322467
email: shiandypumc@sina.com
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
investigator full name: SHI Jia
investigator title: Associate Professor and Vice Chair of the Anesthesiology Department
mesh term: Thrombosis
mesh term: Venous Thrombosis
mesh term: Tranexamic Acid
sharing ipd: No