xml: <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/NCT05994989</url>
    </required_header>
    <id_info>
      <org_study_id>5.26.2023/408</org_study_id>
      <nct_id>NCT05994989</nct_id>
    </id_info>
    <brief_title>Two Different Tranexamic Acid Regimens in Coronary Artery Bypass Surgery</brief_title>
    <official_title>The Effect of Two Different Tranexamic Acid Dose Regimens on Intraoperative and Postoperative Bleeding in Coronary Artery Bypass Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Saglik Bilimleri Universitesi Gazi Yasargil Training and Research 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>
        The primary aim of this study is to observe the effects of two different methods of&#xD;
        administering tranexamic acid (i.v. bolus and i.v. infusion) routinely used intraoperatively&#xD;
        in cardiovascular surgery, on patients' postoperative bleeding amounts. According to the&#xD;
        hypothesis established in this study, it is anticipated that administering tranexamic acid as&#xD;
        an i.v. bolus dose followed by an 8-hour continuous infusion will result in a more stable&#xD;
        blood level compared to the sole i.v. bolus application, thereby being more effective in&#xD;
        influencing postoperative bleeding levels.&#xD;
  &#xD;
        The study has been designed as a prospective observational research. The outcomes of two&#xD;
        different tranexamic acid protocols applied during cardiovascular surgical procedures will be&#xD;
        compared. The first group will consist of patients who receive a 10 mg/kg i.v. bolus of&#xD;
        tranexamic acid after anesthesia induction, followed by an 8-hour i.v. tranexamic acid&#xD;
        infusion at a dose of 2 mg/kg/hour. Group 2 will consist of patients who receive three doses&#xD;
        of tranexamic acid, 10 mg/kg i.v. bolus after anesthesia induction, in the pump, and after&#xD;
        protamine sulfate administration.&#xD;
  &#xD;
        The cases collected over a period of 6 months will be divided into two groups and compared in&#xD;
        terms of intraoperative and postoperative bleeding levels, as well as their need for blood&#xD;
        products.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 14, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 14, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Postoperative hemorrhage</measure>
      <time_frame>Postoperative 1st, 6th and 24th hours</time_frame>
      <description>The amount of bleeding within the first 24 hours postoperatively will be compared.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Postoperative hemorrhage</measure>
      <time_frame>Postoperative first 24 hours</time_frame>
      <description>The amounts of blood and blood products administered within the first 24 hours of postoperative</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Postoperative Hemorrhage</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <description>Patients who have undergone coronary artery bypass surgery and received intravenous tranexamic acid either as a bolus or infusion during the intraoperative period will be included in the study. The cases collected over a period of 6 months will be divided into two groups and compared.&#xD;
  The first group will consist of patients who receive a 10 mg/kg i.v. bolus of tranexamic acid after anesthesia induction, followed by an 8-hour i.v. tranexamic acid infusion at a dose of 2 mg/kg/hour.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <description>Group 2 will consist of patients who receive three doses of tranexamic acid, 10 mg/kg i.v. bolus after anesthesia induction, in the pump, and after protamine sulfate administration.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who have coronary artery disease requiring coronary artery bypass surgery with&#xD;
          cardiopulmonary bypass&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who have coronary artery disease requiring coronary artery bypass surgery&#xD;
               with cardiopulmonary bypass and received intravenous tranexamic acid either as a bolus&#xD;
               or infusion during the intraoperative period will be included in the study.&#xD;
  &#xD;
            -  Wrriten consent obtained&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients operated on for reasons other than coronary artery bypass surgery&#xD;
  &#xD;
            -  Patients who operated on as emergencies&#xD;
  &#xD;
            -  Patients who have preoperative liver/renal dysfunction or a history of cerebrovascular&#xD;
               events&#xD;
  &#xD;
            -  Patients under the age of 18&#xD;
  &#xD;
            -  Patients who have coagulation disorder&#xD;
  &#xD;
            -  Patients who have a history of allergies&#xD;
  &#xD;
            -  Pregnancy or lactation&#xD;
  &#xD;
            -  Disabled in spirit or law&#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_contact>
      <last_name>Osman Uzundere, MD</last_name>
      <phone>+905330206362</phone>
      <email>osmanuzundere@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Gazi Yaşargil Education and Research Hospital</name>
        <address>
          <city>Diyarbakır</city>
          <zip>21070</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Osman Uzundere, M.D.</last_name>
        <phone>+905330206362</phone>
        <email>osmanuzundere@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Guo J, Gao X, Ma Y, Lv H, Hu W, Zhang S, Ji H, Wang G, Shi J. Different dose regimes and administration methods of tranexamic acid in cardiac surgery: a meta-analysis of randomized trials. BMC Anesthesiol. 2019 Jul 15;19(1):129. doi: 10.1186/s12871-019-0772-0.</citation>
      <PMID>31307381</PMID>
    </reference>
    <reference>
      <citation>Zhou ZF, Zhai W, Yu LN, Sun K, Sun LH, Xing XF, Yan M. Comparison of the in-vivo effect of two tranexamic acid doses on fibrinolysis parameters in adults undergoing valvular cardiac surgery with cardiopulmonary bypass - a pilot investigation. BMC Anesthesiol. 2021 Feb 2;21(1):33. doi: 10.1186/s12871-021-01234-8.</citation>
      <PMID>33530942</PMID>
    </reference>
    <reference>
      <citation>Tibi P, McClure RS, Huang J, Baker RA, Fitzgerald D, Mazer CD, Stone M, Chu D, Stammers AH, Dickinson T, Shore-Lesserson L, Ferraris V, Firestone S, Kissoon K, Moffatt-Bruce S. STS/SCA/AmSECT/SABM Update to the Clinical Practice Guidelines on Patient Blood Management. J Extra Corpor Technol. 2021 Jun;53(2):97-124. doi: 10.1182/ject-2100053. No abstract available.</citation>
      <PMID>34194077</PMID>
    </reference>
    <reference>
      <citation>Task Force on Patient Blood Management for Adult Cardiac Surgery of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Association of Cardiothoracic Anaesthesiology (EACTA); Boer C, Meesters MI, Milojevic M, Benedetto U, Bolliger D, von Heymann C, Jeppsson A, Koster A, Osnabrugge RL, Ranucci M, Ravn HB, Vonk ABA, Wahba A, Pagano D. 2017 EACTS/EACTA Guidelines on patient blood management for adult cardiac surgery. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):88-120. doi: 10.1053/j.jvca.2017.06.026. Epub 2017 Sep 30. No abstract available.</citation>
      <PMID>29029990</PMID>
    </reference>
    <reference>
      <citation>Madathil T, Balachandran R, Kottayil BP, Sundaram KR, Nair SG. Comparison of efficacy of two different doses of tranexamic acid in prevention of post operative blood loss in patients with congenital cyanotic heart disease undergoing cardiac surgery. Ann Card Anaesth. 2021 Jul-Sep;24(3):339-344. doi: 10.4103/aca.ACA_162_20.</citation>
      <PMID>34269265</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Osman Uzundere</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Tranexamic acid</keyword>
    <keyword>Coronary artery bypass</keyword>
    <keyword>Hemorrhage</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>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994989
  org study id: 5.26.2023/408
  nct id: NCT05994989
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The primary aim of this study is to observe the effects of two different methods of
        administering tranexamic acid (i.v. bolus and i.v. infusion) routinely used intraoperatively
        in cardiovascular surgery, on patients' postoperative bleeding amounts. According to the
        hypothesis established in this study, it is anticipated that administering tranexamic acid as
        an i.v. bolus dose followed by an 8-hour continuous infusion will result in a more stable
        blood level compared to the sole i.v. bolus application, thereby being more effective in
        influencing postoperative bleeding levels.
  
        The study has been designed as a prospective observational research. The outcomes of two
        different tranexamic acid protocols applied during cardiovascular surgical procedures will be
        compared. The first group will consist of patients who receive a 10 mg/kg i.v. bolus of
        tranexamic acid after anesthesia induction, followed by an 8-hour i.v. tranexamic acid
        infusion at a dose of 2 mg/kg/hour. Group 2 will consist of patients who receive three doses
        of tranexamic acid, 10 mg/kg i.v. bolus after anesthesia induction, in the pump, and after
        protamine sulfate administration.
  
        The cases collected over a period of 6 months will be divided into two groups and compared in
        terms of intraoperative and postoperative bleeding levels, as well as their need for blood
        products.
  observational model: Cohort
  time perspective: Prospective
  measure: Postoperative hemorrhage
  time frame: Postoperative 1st, 6th and 24th hours
  description: The amount of bleeding within the first 24 hours postoperatively will be compared.
  measure: Postoperative hemorrhage
  time frame: Postoperative first 24 hours
  description: The amounts of blood and blood products administered within the first 24 hours of postoperative
  arm group label: Group 1
  description: Patients who have undergone coronary artery bypass surgery and received intravenous tranexamic acid either as a bolus or infusion during the intraoperative period will be included in the study. The cases collected over a period of 6 months will be divided into two groups and compared.
  The first group will consist of patients who receive a 10 mg/kg i.v. bolus of tranexamic acid after anesthesia induction, followed by an 8-hour i.v. tranexamic acid infusion at a dose of 2 mg/kg/hour.
  arm group label: Group 2
  description: Group 2 will consist of patients who receive three doses of tranexamic acid, 10 mg/kg i.v. bolus after anesthesia induction, in the pump, and after protamine sulfate administration.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Osman Uzundere, MD
  phone: +905330206362
  email: osmanuzundere@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Guo J, Gao X, Ma Y, Lv H, Hu W, Zhang S, Ji H, Wang G, Shi J. Different dose regimes and administration methods of tranexamic acid in cardiac surgery: a meta-analysis of randomized trials. BMC Anesthesiol. 2019 Jul 15;19(1):129. doi: 10.1186/s12871-019-0772-0.
  PMID: 31307381
  citation: Zhou ZF, Zhai W, Yu LN, Sun K, Sun LH, Xing XF, Yan M. Comparison of the in-vivo effect of two tranexamic acid doses on fibrinolysis parameters in adults undergoing valvular cardiac surgery with cardiopulmonary bypass - a pilot investigation. BMC Anesthesiol. 2021 Feb 2;21(1):33. doi: 10.1186/s12871-021-01234-8.
  PMID: 33530942
  citation: Tibi P, McClure RS, Huang J, Baker RA, Fitzgerald D, Mazer CD, Stone M, Chu D, Stammers AH, Dickinson T, Shore-Lesserson L, Ferraris V, Firestone S, Kissoon K, Moffatt-Bruce S. STS/SCA/AmSECT/SABM Update to the Clinical Practice Guidelines on Patient Blood Management. J Extra Corpor Technol. 2021 Jun;53(2):97-124. doi: 10.1182/ject-2100053. No abstract available.
  PMID: 34194077
  citation: Task Force on Patient Blood Management for Adult Cardiac Surgery of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Association of Cardiothoracic Anaesthesiology (EACTA); Boer C, Meesters MI, Milojevic M, Benedetto U, Bolliger D, von Heymann C, Jeppsson A, Koster A, Osnabrugge RL, Ranucci M, Ravn HB, Vonk ABA, Wahba A, Pagano D. 2017 EACTS/EACTA Guidelines on patient blood management for adult cardiac surgery. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):88-120. doi: 10.1053/j.jvca.2017.06.026. Epub 2017 Sep 30. No abstract available.
  PMID: 29029990
  citation: Madathil T, Balachandran R, Kottayil BP, Sundaram KR, Nair SG. Comparison of efficacy of two different doses of tranexamic acid in prevention of post operative blood loss in patients with congenital cyanotic heart disease undergoing cardiac surgery. Ann Card Anaesth. 2021 Jul-Sep;24(3):339-344. doi: 10.4103/aca.ACA_162_20.
  PMID: 34269265
  responsible party type: Principal Investigator
  investigator affiliation: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
  investigator full name: Osman Uzundere
  investigator title: Principal Investigator
  mesh term: Hemorrhage
  mesh term: Postoperative Hemorrhage
  sharing ipd: Undecided