<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20180724040575N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-29</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effect of tranexamic acid on coronary perfusion</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of different doses of tranexamic acid on coronary perfusion in patients undergoing coronary artery bypass graft surgery (CABG)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32930</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: All patients who go to the cardiac operating room from the beginning of sampling and meet the necessary criteria are included in the study. For assignment in intervention and control groups, simple randomization method is used with the help of random numbers(RAND) in Excel software. In cell A1, type the formula = RAND () * (120-1) +1. By confirming and dragging to A60, we have sixty random numbers between 1 and 120. These numbers are the rows of participants in the intervention group(high dose tranexamic acid). For each row of participants, a closed envelope is prepared by the researcher not present in the operating room, and with the arrival of each patient, the relevant envelope is opened by the project partner in the operating room and the designated group is determined, Blinding description: Consent for participation in the study is obtained from all patients, but the participants and  data collector are blind about the study groups. The researcher and patient care team are aware of the groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Coronary artery bypass graft surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients undergoing coronary artery bypass graft receiving a high dose of tranexamic acid. In this group, after induction of anesthesia, tranexamic acid drug made by Caspian Pharmaceutical Company (500 mg vial in 5 ml) at a dose of 25 mg / kg body weight by slow intravenous injection as a loading dose and then 5 mg / kg body weight It is given as an intravenous infusion as a maintenance dose until the end of the operation. Intravenous infusion is performed with the help of a pump syringe and the drug dissolved in a 50 ml syringe. Intervention 2: Control group: Patients undergoing coronary artery bypass graft receiving a standard dose of tranexamic acid. In this group, after induction of anesthesia, tranexamic acid drug made by Caspian Pharmaceutical Company (500 mg in 5 ml) at a dose of 10 mg / kg body weight by slow intravenous injection as a loading dose and then 2 mg / kg body weight It is given as an intravenous infusion as a maintenance dose until the end of the operation. Intravenous infusion is performed with the help of a pump syringe and the drug dissolved in a 50 ml syringe.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kamal Fani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani Hospital, Velenjak,Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996911151</zip>
        <telephone>+98 21 2207 4089</telephone>
        <email>kamalfani@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kamal Fani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani Hospital, Velenjak, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996911151</zip>
        <telephone>+98 21 2207 4089</telephone>
        <email>kamalfani@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients under CABG surgery
Ejection Fraction(EF) &gt;40%</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Tranexamic acid sensitivity
Convulsion history
Thromboembolic event history</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients undergoing coronary artery bypass graft receiving a high dose of tranexamic acid. In this group, after induction of anesthesia, tranexamic acid drug made by Caspian Pharmaceutical Company (500 mg vial in 5 ml) at a dose of 25 mg / kg body weight by slow intravenous injection as a loading dose and then 5 mg / kg body weight It is given as an intravenous infusion as a maintenance dose until the end of the operation. Intravenous infusion is performed with the help of a pump syringe and the drug dissolved in a 50 ml syringe.</i_keyword>
      <i_keyword>Control group: Patients undergoing coronary artery bypass graft receiving a standard dose of tranexamic acid. In this group, after induction of anesthesia, tranexamic acid drug made by Caspian Pharmaceutical Company (500 mg in 5 ml) at a dose of 10 mg / kg body weight by slow intravenous injection as a loading dose and then 2 mg / kg body weight It is given as an intravenous infusion as a maintenance dose until the end of the operation. Intravenous infusion is performed with the help of a pump syringe and the drug dissolved in a 50 ml syringe.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cardiac enzymes. Timepoint: Before and 24 hours after surgery. Method of measurement: Eliza method for cardiac enzymes measurment.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-20</approval_date>
        <contact_name>Ethics committee of shahid beheshti University of Medical Sciences</contact_name>
        <contact_address>Taleghani Hospital, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
