<?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>IRCT20171230038142N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-16</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Handmade Del Nido Cardioplegia Solution with Handmade St. Thomas Cardioplegia Solution in terms of Quantitative Levels of Cardiac Troponin I and Phosphocreatine kinase MB.</public_title>
      <acronym></acronym>
      <scientific_title>A Comparative Study on the Effect of Handmade Del Nido Cardioplegia Solution with Handmade St. Thomas Cardioplegia Solution in terms of Quantitative Levels of Cardiac Troponin I and Phosphocreatine kinase MB  in Ventricular Septal Defect Repair in Pediatric Cardiac Surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/38309</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Female or male patients undergoing surgical repair of large-inferior ventricular diarrhea were easily and conveniently distributed in Chamran Hospital in Isfahan. Then they are randomly assigned random allocation and random numbers in two groups of 30, which will be used in a group of St. Thomas's handmade solution and in another group of Del NIDO solution, Blinding description: The samples are not aware of the therapeutic type and only the presenter is aware of the categorization of patients in each treatment group. Because these two solutions are injected during surgery, so patients are unaware of their drug type.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Ventricular Septal Defect Repair.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: 30 patients receiving St. Thomas cardiopulmonary by hand perfringens with a dose of 20 ml per kg and at a temperature of 4 degrees Celsius. This solution is surgically dispensed immediately before injection of the cardioplegia solution sterilized. Then, through a cardioplegia cannula inserted by the surgeon at the root of the aorta, it is injected through the syringe. The injection rate of the cardiopulse solution is 30 to 40 mmHg and during 2 minutes and is controlled by pressure gauge in the injection route. This solution is injected into the patient in a single dose. Intervention 2: Intervention group: Intervention group: 30 patients with cardiogenic cardiopulmonary bypass grafting by perfusion. This solution is a dose of 15 ml per kilogram and a ratio of four crystalloid units at 4 ° C and one unit of complete oxygenated blood. Both solutions are surgically dispensed sterilized immediately after injection of the cardiopulmonary solution. A cardioplegia cannula inserted by the surgeon at the root of the aorta is injected through the syringe. The injection rate of the cardiopulse solution is 30 to 40 mmHg and in the It is in 2 minutes and is controlled by pressure gauge in the injection route. This solution is injected into the patient in a single dose.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data is unpublished after being unidentifiable and two years after the article is published.

When:
Two years after the publication and publication of the results.

To whom:
Assistants and Professors of the Department of Heart Surgery and Circulation Technology.

Conditions:
To compare the effects of other handmade solutions on the low levels of troponin I and phospho creatine kinase MB with the present results.

Where to obtain:
Accepting permission from the research vice president of Isfahan University of Medical Sciences.

How to obtain:
Accepting permission from the research vice president of Isfahan University of Medical Sciences.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Bigdelian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences, Hezar Jarib Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 316680048</telephone>
        <email>mortezasadeghi16@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Bigdelian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Isfahan University of Medical Sciences, Hezar Jarib Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81746-73461</zip>
        <telephone>+98 31 3668 0048</telephone>
        <email>mortezasadeghi16@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having less than 12 years of age.
Parental satisfaction from intervention.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a history of heart failure.
Having a history of myocardial infarction.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I23.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ventricular septal defect as current complication following acute myocardial infarction</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: Intervention group: 30 patients receiving St. Thomas cardiopulmonary by hand perfringens with a dose of 20 ml per kg and at a temperature of 4 degrees Celsius. This solution is surgically dispensed immediately before injection of the cardioplegia solution sterilized. Then, through a cardioplegia cannula inserted by the surgeon at the root of the aorta, it is injected through the syringe. The injection rate of the cardiopulse solution is 30 to 40 mmHg and during 2 minutes and is controlled by pressure gauge in the injection route. This solution is injected into the patient in a single dose.</i_keyword>
      <i_keyword>Intervention group: Intervention group: 30 patients with cardiogenic cardiopulmonary bypass grafting by perfusion. This solution is a dose of 15 ml per kilogram and a ratio of four crystalloid units at 4 ° C and one unit of complete oxygenated blood. Both solutions are surgically dispensed sterilized immediately after injection of the cardiopulmonary solution. A cardioplegia cannula inserted by the surgeon at the root of the aorta is injected through the syringe. The injection rate of the cardiopulse solution is 30 to 40 mmHg and in the It is in 2 minutes and is controlled by pressure gauge in the injection route. This solution is injected into the patient in a single dose.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quantitative Levels of Cardiac Troponin I. Timepoint: Before surgery, six hours and 12 hours after surgery. Method of measurement: Patient blood sample test.</prim_outcome>
      <prim_outcome>Quantitative Levels of Phosphocreatine kinase MB. Timepoint: Before surgery, six hours and 12 hours after surgery. Method of measurement: Patient blood sample test.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-20</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezar Jarib Ave. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
