<?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>IRCT2017102625488N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-11-04</date_registration>
      <primary_sponsor>Vice chancellor for research and technology, Arak University of Medical Sciences</primary_sponsor>
      <public_title>Effect of method of cardiac arresting on outcomes following bypass surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of simultaneous antegrade.venous graft cardioplegia infusion to conventional method in coronary artery bypass grafting</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>178</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21311</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Simple randomization technique using SAS software version 9.4 will be applied for randomized allocation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Coronary artery disease. Condition 2: Coronary artery bypass graft.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  Mostly crystalloid cardioplegia (2% blood to prevent obscuring of the operative field), is infused continuously through vein grafts by a separate infusion set, once each distal anastomosis is completed at a rate of 10 to 20 mL per minute. This infusion is continued until half of the last distal anastomosis performed. The traditional method of intermittent cold blood (4 degrees Celsius) cardioplegia instillation, repeated every 20 minutes is implemented as well. Intervention 2: Control group: Antegrade cold blood cardioplegia (at a ratio of 4 to 1) is infused via aortic root by means of a cannula inserted by the surgeon at the middle part of ascending aorta. This injection conducting by the perfusionist, usually lasts about 3 minutes and should be repeated every 20 minutes (intermittent fashion).</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehrzad Sharifi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Cardiac surgery department, Amiralmomenin hospital, Sardasht square</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 3417 3602</telephone>
        <email>m.sharifi@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehrzad Sharifi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Cardiac surgery department, Amiralmomenin hospital, Sardasht square</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 86 3417 3602</telephone>
        <email>m.sharifi@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Coronary artery disease patients scheduled for  first-time elective isolated on-pump CABG&#13;
Exclusion criteria:&#13;
1. Redo CABG&#13;
2. Urgent CABG&#13;
3. Off-pump CABG&#13;
4. Combined operations including CABG in addition to valve repair or replacement&#13;
5. Unexpected intra-operative complications e.g. aortic rupture during cannulation</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>125.1</hc_code>
      <hc_code>T82.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease</hc_keyword>
      <hc_keyword>Mechanical complication of coronary artery bypass and valve grafts</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  Mostly crystalloid cardioplegia (2% blood to prevent obscuring of the operative field), is infused continuously through vein grafts by a separate infusion set, once each distal anastomosis is completed at a rate of 10 to 20 mL per minute. This infusion is continued until half of the last distal anastomosis performed. The traditional method of intermittent cold blood (4 degrees Celsius) cardioplegia instillation, repeated every 20 minutes is implemented as well.</i_keyword>
      <i_keyword>Control group: Antegrade cold blood cardioplegia (at a ratio of 4 to 1) is infused via aortic root by means of a cannula inserted by the surgeon at the middle part of ascending aorta. This injection conducting by the perfusionist, usually lasts about 3 minutes and should be repeated every 20 minutes (intermittent fashion).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The need for balloon pump. Timepoint: During and after weaning. Method of measurement: Number (percentage).</prim_outcome>
      <prim_outcome>The need for inotrope. Timepoint: During and after weaning. Method of measurement: Number (percentage).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Other complications including neurologic, renal, and pulmonary complications. Timepoint: Within one month after surgery. Method of measurement: Number (percentage).</sec_outcome>
      <sec_outcome>The amount of bleeding. Timepoint: Within 24 hours following surgery. Method of measurement: mL.</sec_outcome>
      <sec_outcome>Serum level of potassium. Timepoint: Immediately upon arrival to ICU. Method of measurement: mEq/L.</sec_outcome>
      <sec_outcome>The rate of perioperative myocardial infarction. Timepoint: During hospitalization. Method of measurement: Number (percentage).</sec_outcome>
      <sec_outcome>Hospital mortality. Timepoint: During hospitalization. Method of measurement: Number (percentage).</sec_outcome>
      <sec_outcome>The rate of postoperative arrhythmia. Timepoint: During ICU stay. Method of measurement: Number (percentage).</sec_outcome>
      <sec_outcome>Peak serum level of CK, CK-MB, and cTnI. Timepoint: At 12 hours following operation in the ICU. Method of measurement: mcg/L.</sec_outcome>
      <sec_outcome>The rate of superficial or deep wound infection. Timepoint: During hospitalization. Method of measurement: Number (percentage).</sec_outcome>
      <sec_outcome>The rate of re-exploration due to hemorrhage or tamponade. Timepoint: Within 24 hours following surgery in the ICU. Method of measurement: Number (percentage).</sec_outcome>
      <sec_outcome>Ventilation time. Timepoint: Within 24 hours following surgery in the ICU. Method of measurement: Hours.</sec_outcome>
      <sec_outcome>Arterial level of base excess (BE). Timepoint: Within one hour after arrival to ICU. Method of measurement: mmol/L.</sec_outcome>
      <sec_outcome>Duration of ICU stay. Timepoint: following surgery. Method of measurement: Days.</sec_outcome>
      <sec_outcome>Duration of hospital stay. Timepoint: following surgery. Method of measurement: Days.</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>Vice chancellor for research and technology, Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-22</approval_date>
        <contact_name>Arak University of Medical Sciences</contact_name>
        <contact_address>Arak University of Medical Sciences, Shahid Shiroodi st., Alamolhoda st. Arak  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
