<?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>IRCT20191216045755N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-27</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The Evaluation Of Adding Erythropoietin In Cardioplegic Solution On The Time Required for Mechanical Ventilation and The Need for Inotrop In Pattions After CABG In Rasool-e-Akram Hospital</public_title>
      <acronym></acronym>
      <scientific_title>The Evaluation Of Adding Erythropoietin In Cardioplegic Solution On The Time Required for Mechanical Ventilation and The Need for Inotrop In Pattions After CABG In Rasool-e-Akram Hospital In The First 6 Months of 1398</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44293</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to inclusion and exclusion criteria, patients are admitted to the hospital within the specified interval. Then, patients are divided into two intervention and control groups using simple random method and random number table. Patients are identified and then each patient is assigned a code, and patients are selected by pointing the finger or the tip of the pen or closing their eyes according to the code, one of which is divided into the intervention and comparison groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Coronary ischemic patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Erythropoietin is a precursor of erythrocytes (erythrocytes) which in the intravenous form has no side effects except mild nausea and hypertension and also has a protective effect against cardiac ischemia. Anesthesia (given as premedication midazolam .015mg / kg and Fentanyl 2_10macro / kg ketamin 50mg infusion and given as induction of neonatal 2_5mg / kg and pawlone 0.1mg / kg in patients with primary creatinine above 1.5 instead of Pavlovian Atracoril) Specific ionic and preservative concentrations and compounds in accordance with the national protocol of 15 cc per kg of bad weight It is injected over 3 minutes at 4 ° C with a pressure of 50-50 mm Hg through the aortic root to achieve complete cardiac arrest. In this group, a vial of erythropoietin manufactured by Synagen. 4,000 units are added intravenously to the cardioplegia solution, which is injected with the other compounds into the cardiovascular system. Intervention 2: Control group: No extra work.</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 I haven't consulted</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Behdad Maadani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mansoori Ave, Niayesh Ave ,Sattarkhan Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8874113911</zip>
        <telephone>+98 21 8861 0120</telephone>
        <email>behdad_madaani@hotmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behdad Madaani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mansoori Ave, Niayesh Ave ,Sattarkhan Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8874113911</zip>
        <telephone>+98 21 8861 0120</telephone>
        <email>behdad_madaani@hotmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with ischemic coronary artery disease who are not eligible for angiographic treatment and who are candidates for surgery for coronary artery disease (CABG)                                    2-Patients with ischemic coronary artery disease aged 40 to 80 years</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1- Patients undergoing heart replacement surgery under open heart surgery                                                                                        2- Anatomical heart disease undergoing open heart surgery             3- Patients with coronary artery disease who have cardiac-respiratory arrest under open heart surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic ischemic heart disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:Erythropoietin is a precursor of erythrocytes (erythrocytes) which in the intravenous form has no side effects except mild nausea and hypertension and also has a protective effect against cardiac ischemia. Anesthesia (given as premedication midazolam .015mg / kg and Fentanyl 2_10macro / kg ketamin 50mg infusion and given as induction of neonatal 2_5mg / kg and pawlone 0.1mg / kg in patients with primary creatinine above 1.5 instead of Pavlovian Atracoril) Specific ionic and preservative concentrations and compounds in accordance with the national protocol of 15 cc per kg of bad weight It is injected over 3 minutes at 4 ° C with a pressure of 50-50 mm Hg through the aortic root to achieve complete cardiac arrest. In this group, a vial of erythropoietin manufactured by Synagen. 4,000 units are added intravenously to the cardioplegia solution, which is injected with the other compounds into the cardiovascular system.</i_keyword>
      <i_keyword>Control group: No extra work</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The presence or absence of erythropoietin in the cardioplegia solution. Timepoint: After surgery. Method of measurement: Researcher Information.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Total postoperative hospital stay. Timepoint: After Surgery. Method of measurement: Based on the case.</sec_outcome>
      <sec_outcome>Duration of ICU admission. Timepoint: Operation time until leaving ICU. Method of measurement: Based on the case.</sec_outcome>
      <sec_outcome>The dose of inotropes required after surgery. Timepoint: After Surgery. Method of measurement: Based on the case.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-08-27</approval_date>
        <contact_name>Iran University of Medical Sciences</contact_name>
        <contact_address>Mansoori Ave, Niayesh Ave ,Sattarkhan Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
