<?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>IRCT20200602047642N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-07</date_registration>
      <primary_sponsor>Shahid Rajaei Heart Hospital, Tehran</primary_sponsor>
      <public_title>Clinical outcome of Pulsatile flow</public_title>
      <acronym></acronym>
      <scientific_title>Determination and comparison of the effect of 30 and 70 pulses in pulsatile cardiopulmonary bypass on clinical outcome of patients undergoing Coronary Artery Bypass Graft (CABG) surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49062</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Allocation of individuals to study groups (interventions and controls) was performed by randomized block method using 6 blocks. This was done with the relevant software by Master of Statistics. In each block there are 2 people related to the control group, 2 people related to the A intervention group and 2 people related to the B group, whose order was random and the blocks were selected using the table of random numbers, Blinding description: Patients are given explanations about the study and the three groups to be studied, and then they are asked to enter the study, but they are not told which group they are studying.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Atherosclerotic heart disease.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: In the heart and lung pump machine, the pulse flow settings are as follows: Pulse number: 30, base flute: 30%, pulse width: 40%. After the pump starts and immediately after the aortic clamp, the pulsating current will start, and after removing the clamp, the aorta will end and the pump will continue with the continuous flow. Intervention 2: Second intervention group: In the heart and lung pump machine, the pulse flow settings are as follows: Pulse number: 70, base flute: 30%, pulse width: 40%. After the pump starts and immediately after the aortic clamp, the pulsating current will start and after removing the clamp the aorta will end and the pump will continue with the continuous flow. Intervention 3: Control group: Patients in this group are only subjected to a continuous flow, which by default is set in the pump machine, and no other adjustments are made.</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>Neda Habibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Rajaei Heart Hospital , Niayesh Intersection,Valiasr St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1995614331</zip>
        <telephone>+98 21 23921</telephone>
        <email>neda.nahi@yahoo.com</email>
        <affiliation>Rajaei Cardiovascular Hospital, Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Neda Habibi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Rajaei Heart Hospital., Niayesh Intersection,Valiasr St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1995614331</zip>
        <telephone>+98 21 23921</telephone>
        <email>neda.nahi@yahoo.com</email>
        <affiliation>Rajaei Cardiovascular Hospital, Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient satisfaction to enter the study
Patients in the age range of 40-65 years
Elective patients are candidates for Coronary Artery Bypass Graft surgery
Patients with ejection fraction above 30%</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a history of heart surgery
Having another processor with Coronary Artery Bypass Graft
Liver failure as ALT&gt; 40 units / l AST&gt; 40 units / l
Preoperative pulmonary function test in the form of FEV1 &lt;65%
Having a creatinine level above 2 mg/dl
Having a hemoglobin level of less than 10 mg/dl</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease of native coronary artery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: In the heart and lung pump machine, the pulse flow settings are as follows: Pulse number: 30, base flute: 30%, pulse width: 40%. After the pump starts and immediately after the aortic clamp, the pulsating current will start, and after removing the clamp, the aorta will end and the pump will continue with the continuous flow.</i_keyword>
      <i_keyword>Second intervention group: In the heart and lung pump machine, the pulse flow settings are as follows: Pulse number: 70, base flute: 30%, pulse width: 40%. After the pump starts and immediately after the aortic clamp, the pulsating current will start and after removing the clamp the aorta will end and the pump will continue with the continuous flow.</i_keyword>
      <i_keyword>Control group: Patients in this group are only subjected to a continuous flow, which by default is set in the pump machine, and no other adjustments are made.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Liver enzymes. Timepoint: Before, 24 and 48 hours after the operation. Method of measurement: Lab kits.</prim_outcome>
      <prim_outcome>Renal enzymes. Timepoint: Before, 24 and 48 hours after the operation. Method of measurement: Lab kits.</prim_outcome>
      <prim_outcome>Blood lactate. Timepoint: Before, 24 and 48 hours after the operation. Method of measurement: Lab kits.</prim_outcome>
      <prim_outcome>Urine. Timepoint: Before the pump, during the pump, 12 and 24 hours after the operation. Method of measurement: Urine bag.</prim_outcome>
      <prim_outcome>Bleeding. Timepoint: 12 and 24 hours after the operation. Method of measurement: Chest tube.</prim_outcome>
      <prim_outcome>Inotropic consumption. Timepoint: 12 and 24 hours after the operation. Method of measurement: Yes/No.</prim_outcome>
      <prim_outcome>Long stay at the intensive care unit. Timepoint: In the intensive care unit. Method of measurement: Hours recorded in the patient's file.</prim_outcome>
      <prim_outcome>The duration of the intubation. Timepoint: In the intensive care unit. Method of measurement: Hours recorded in the file.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Consumption of blood and blood products. Timepoint: In the operating room and Intensive care unit. Method of measurement: Each unit of product consumed.</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 Rajaei Heart Hospital, Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-25</approval_date>
        <contact_name>Ethics Committee of Shahid Rajaei Heart Hospital in Tehran</contact_name>
        <contact_address>Shahid Rajaei Heart Hospital., Niayesh Intersection,Valiasr St Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
