<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/NCT03244423</url>
  </required_header>
  <id_info>
    <org_study_id>IRB0000879560</org_study_id>
    <nct_id>NCT03244423</nct_id>
  </id_info>
  <brief_title>Tranexamic Acid in Cyanotic Heart Defects</brief_title>
  <official_title>Tranexamic Acid in Cyanotic Heart Defects: a Risk-benefit Analysis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of antifibrinolytic agents such as to reduce blood loss in congenital cardiac surgery&#xD;
      has been described in many studies&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      40 patients in each one of the three groups; In control group will receive normal saline,&#xD;
      Intravenous Tranexamic acid group received 50 mg / kg intravenousely followed by of 1&#xD;
      mg/kg/hr.for six hours. The topical Tranexamic acid group will have 50 mg / kg of tranexamic&#xD;
      poured into the pericoredial cavity. in the first 24 hours we will measure the total blood&#xD;
      loss and transfusion requirements. Complate blood picture and coagulation studies will be&#xD;
      recorded. the occurrence of re-exploration for excess bleeding, or adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2009</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative blood loss</measure>
    <time_frame>within the first 24 hours</time_frame>
    <description>Blood loss will be measured within first 24 hr.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>total blood transfusion</measure>
    <time_frame>within the first 24 hours</time_frame>
    <description>ml/kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the interval from protamine to skin closure</measure>
    <time_frame>within the first 24 hours</time_frame>
    <description>the interval from protamine to skin closure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the length of ICU stay</measure>
    <time_frame>within the first month</time_frame>
    <description>by days</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Postoperative Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In control group will receive normal saline,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intravenous Tranexamic acid group will received Intravenous 50 mg / kg followed by infusion of 1 mg/kg/hr for six hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the topical Tranexamic acid group will receive 50 mg / kg poured before sternal closure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline at induction</intervention_name>
    <description>0.5 ml/kg</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline infusion</intervention_name>
    <description>1ml/kg/hr. during surgery for six hours</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous tranexamic acid</intervention_name>
    <description>50 mg/kg</description>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>infusion tranexamic acid</intervention_name>
    <description>1mg/kg/hr infusionfor 6 hours</description>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>topical tranexamic acid</intervention_name>
    <description>50 mg/kg added to the normal saline 2 ml/kg into the pericardial cavity before sternal closure</description>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>topical normal saline</intervention_name>
    <description>2 ml/kg into the pericardial cavity before sternal closure</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        2 to 12 years cyanotic cardiac disease with cardio pulmonary bypass&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Previous cardiac surgery any operation within 48 hr., previous inotropes or mechanical&#xD;
        vention aprotinin exposure Liver or renal impairment Coagulation or hemostatic dysfunction&#xD;
        within the last 7 days before surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sayed k Abd-Elshafy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate profossor of anesthesiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Assiut</city>
        <zip>74111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>January 30, 2018</last_update_submitted>
  <last_update_submitted_qc>January 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Sayed Kaoud Abd-Elshafy</investigator_full_name>
    <investigator_title>Associate Profossor of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>Pediatric</keyword>
  <keyword>Cyanotic heart disease</keyword>
  <keyword>Tranexamic acid</keyword>
  <keyword>Postoperative blood loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Postoperative Hemorrhage</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>Undecided</sharing_ipd>
    <ipd_description>UNDECIDED</ipd_description>
  </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/NCT03244423
org study id: IRB0000879560
nct id: NCT03244423
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The use of antifibrinolytic agents such as to reduce blood loss in congenital cardiac surgery
      has been described in many studies
40 patients in each one of the three groups; In control group will receive normal saline,
      Intravenous Tranexamic acid group received 50 mg / kg intravenousely followed by of 1
      mg/kg/hr.for six hours. The topical Tranexamic acid group will have 50 mg / kg of tranexamic
      poured into the pericoredial cavity. in the first 24 hours we will measure the total blood
      loss and transfusion requirements. Complate blood picture and coagulation studies will be
      recorded. the occurrence of re-exploration for excess bleeding, or adverse events.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: postoperative blood loss
time frame: within the first 24 hours
description: Blood loss will be measured within first 24 hr.
measure: total blood transfusion
time frame: within the first 24 hours
description: ml/kg
measure: the interval from protamine to skin closure
time frame: within the first 24 hours
description: the interval from protamine to skin closure
measure: the length of ICU stay
time frame: within the first month
description: by days
arm group label: Group 1
arm group type: Placebo Comparator
description: In control group will receive normal saline,
arm group label: Group 2
arm group type: Active Comparator
description: Intravenous Tranexamic acid group will received Intravenous 50 mg / kg followed by infusion of 1 mg/kg/hr for six hours
arm group label: Group 3
arm group type: Active Comparator
description: the topical Tranexamic acid group will receive 50 mg / kg poured before sternal closure.
intervention type: Drug
intervention name: Normal saline at induction
description: 0.5 ml/kg
arm group label: Group 1
arm group label: Group 3
intervention type: Drug
intervention name: Normal saline infusion
description: 1ml/kg/hr. during surgery for six hours
arm group label: Group 1
arm group label: Group 3
intervention type: Drug
intervention name: Intravenous tranexamic acid
description: 50 mg/kg
arm group label: Group 2
intervention type: Drug
intervention name: infusion tranexamic acid
description: 1mg/kg/hr infusionfor 6 hours
arm group label: Group 2
intervention type: Drug
intervention name: topical tranexamic acid
description: 50 mg/kg added to the normal saline 2 ml/kg into the pericardial cavity before sternal closure
arm group label: Group 3
intervention type: Drug
intervention name: topical normal saline
description: 2 ml/kg into the pericardial cavity before sternal closure
arm group label: Group 1
arm group label: Group 2
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
healthy volunteers: No
last name: Sayed k Abd-Elshafy, MD
role: Principal Investigator
affiliation: Associate profossor of anesthesiology
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Sayed Kaoud Abd-Elshafy
investigator title: Associate Profossor of Anesthesiology
mesh term: Hemorrhage
mesh term: Postoperative Hemorrhage
mesh term: Tranexamic Acid
sharing ipd: Undecided
ipd description: UNDECIDED