<?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>IRCT2016073029123N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-10-11</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Assessment effect of replacement  liquid (crystalloid and colloid ) used for deairing circuits of cardiopulmonary bypass by patient own blood  in patient undergoing coronary artery bypass grafting on clinical outcome</public_title>
      <acronym></acronym>
      <scientific_title>Assessment Effect of retrograde autologous priming on clinical outcome of heart lung bypassing on patients undergoing coronary artery bypass grafting</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23487</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Coronary artery disease.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group before the start of cardiopulmonary bypass and After the arterial cannulation by the surgeon we allow the patient blood reversely enter in arterial line by aorta pressure And at the same time  we opened The bags Direction that had been placed on one of the output circuti and allowed equal the blood that inter from  arterial line into circuit Priming fluid out.After leaving the arterial fluid circuit we have closed the arterial line and Action to spin pumps are connected to the oxygenator with slow motion And because the only output in the circuit is the collecting bags that connected to the circuit, liquid in the reservoir as much as possible inter in the collecting bag.In the final stage, when the patient's venous blood opens to the reservoir of the cardiopulmonary bypass, we attempt to extract this liquid from reservoir.Through the method that said in the intervention  group In coordination with the Department of Anesthesiology to prevent hypotension,we extract 300-600 Milliliters of liquid prime and replace it with the patient's blood. Intervention 2: In the control group cardiopulmonary bypass circuits primed with conventional method (approximately1500 ml of crystalloid and colloid).And this fluid volume remains in the cardiopulmonary bypass circuit and  inter to the patient body with the starting of the bypass.</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>Musa Rafiee Vardanjany</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing, Iran University of Medical Sciences, Rasheed Yaasemi street, Valiasr street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 8888 2886</telephone>
        <email>musa rafiee7@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Nooredin Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing, Rasheed Yaasami Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 8828 8698</telephone>
        <email>nooredin.mohammadi@yahoo.com</email>
        <affiliation>School of Nursing, Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: adult patients undergoing coronary artery bypass surgery using cardiopulmonary bypass; no history of past heart surgery; age older than 18 and less than 70 years old; hemoglobin level greater than 8.5 and less than 14; body weight more than 45 kg and less than 100 kg; left ventricular ejection fraction greater than 25%.&#13;
Exclusion criteria: history of cardiac surgery; the patient or the patient's family  withdraw from the study during the intervention period; emergency surgery; severe infection; clotting problems before surgery (INR&gt; 1.2, aPTT&gt; 40 s and blood platelet count less than 100 thousand per cubic meter);  danapyroid and Lepyrudyn and dabigatran drug in the month before the operation; use Hemofilter and Cell Saver; the use of preoperative mechanical ventilation; dialysis before surgery; the existence of liver failure as (AST&gt; 40 unit / L) and  ((ALT&gt; 40 unit / L before surgery.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I20-I25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ischaemic heart diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group before the start of cardiopulmonary bypass and After the arterial cannulation by the surgeon we allow the patient blood reversely enter in arterial line by aorta pressure And at the same time  we opened The bags Direction that had been placed on one of the output circuti and allowed equal the blood that inter from  arterial line into circuit Priming fluid out.After leaving the arterial fluid circuit we have closed the arterial line and Action to spin pumps are connected to the oxygenator with slow motion And because the only output in the circuit is the collecting bags that connected to the circuit, liquid in the reservoir as much as possible inter in the collecting bag.In the final stage, when the patient's venous blood opens to the reservoir of the cardiopulmonary bypass, we attempt to extract this liquid from reservoir.Through the method that said in the intervention  group In coordination with the Department of Anesthesiology to prevent hypotension,we extract 300-600 Milliliters of liquid prime and replace it with the patient's blood.</i_keyword>
      <i_keyword>In the control group cardiopulmonary bypass circuits primed with conventional method (approximately1500 ml of crystalloid and colloid).And this fluid volume remains in the cardiopulmonary bypass circuit and  inter to the patient body with the starting of the bypass.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes in arterial blood gases. Timepoint: Before anesthesia, intraoperative and postoperative. Method of measurement: content of each gas in arterial blood Under the pressure of eac gas.</prim_outcome>
      <prim_outcome>The need for blood  and blood products transfusions during surgery. Timepoint: During Surgery. Method of measurement: The number of bags of blood and blood products in terms of unit.</prim_outcome>
      <prim_outcome>The amount of postoperative blood and blood product transfusion. Timepoint: After surgery and during the hospitalization. Method of measurement: The number of bags of blood and blood products.</prim_outcome>
      <prim_outcome>Duration of mechanical ventilation connection. Timepoint: During the intensive care unit. Method of measurement: Duration of mechanical ventilation connection based on hours.</prim_outcome>
      <prim_outcome>Ejection fraction. Timepoint: After surgery in ward. Method of measurement: Ratio between strok volume to end diastolic volume according to percent.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hemoglobin - Hematocrit. Timepoint: During the operation, 12,24 and 48 hours after surgery. Method of measurement: The amount of hemoglobin  according to  milligrams per deciliter and hematocrit according percent.</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>2016-06-29</approval_date>
        <contact_name>Iran University of Medical Sciences</contact_name>
        <contact_address>Besides Milad Tower, Tehran, Hemmat Highway Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
