<?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>IRCT2013082714489N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-04-07</date_registration>
      <primary_sponsor>Vice chancellor for research, Mashhad university of medical sciences</primary_sponsor>
      <public_title>Effect of fibrinogen on bleeding after cardiac surgery</public_title>
      <acronym></acronym>
      <scientific_title>Studying effect of tranexamic acid plus fibrinogen on mediastinal bleeding in cardiac patients after open heart surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14116</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The subjects are divided into control and intervention groups according to random number table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Ischemic heart diseases. Condition 2: Nonrheumatic mitral valve disorders. Condition 3: Nonrheumatic aortic valve disorders. Condition 4: Nonrheumatic tricuspid valve disorders. Condition 5: Pulmonary valve disorders. Condition 6: Rheumatic heart diseases.</hc_freetext>
      <i_freetext>Intervention 1: The subjects in the intervention group are injected with 15mg/kg tranexamic acid plus 2 g(grams) fibrinogen (Haemocomplettan as the generic name). Afterwards, the length of stay in the ICU, mediastinal bleeding, use of blood products, intubation time in ICU, discharge conditions and mortality are registered for each subject. These drugs are intravenously injected in one session, immediately after mediastinal bleeding of more than 200 cc/hr. The last stage in non-responder patients is re-exploration. Intervention 2: The second group consists of control subjects who receive 15 mg/kg tranexamic acid and routine care (including blood pressure control and use of blood products according to the paraclinical findings). The last stage in non-responder patients is re-exploration.</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>Doctor Mohammad Esmaeelzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Reza hospital, Emam Reza square, Ebne sina street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 1802 2314</telephone>
        <email>Esmaeilzm901@mums.ac.ir</email>
        <affiliation>Mashhad university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Doctor Shahram Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Reza hospital, Emam Reza square, Ebne Sina street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 1802 2314</telephone>
        <email>Aminish@mums.ac.ir</email>
        <affiliation>Mashhad university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1) Mediastinal drainage of more than 200 cc/hour after cardiac surgery, 2) Age&lt;70 years, 3) Ejection Fraction (EF)&gt;30% and 4) Body Mass Index (BMI)&lt;30;&#13;
Exclusion criteria: 1) Emergency or second cardiac surgery, 2) Hemoglobin (Hb)&lt;10, 3) platelet count&lt;100,000/cc, and 4) Hematologic diseases</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I20.9</hc_code>
      <hc_code>I34.9</hc_code>
      <hc_code>I35.9</hc_code>
      <hc_code>I36.9</hc_code>
      <hc_code>I37.9</hc_code>
      <hc_code>I01.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Angina pectoris, unspecified</hc_keyword>
      <hc_keyword>Nonrheumatic mitral valve disorders, unspecified</hc_keyword>
      <hc_keyword>Nonrheumatic aortic valve disorders, unspecified</hc_keyword>
      <hc_keyword>Nonrheumatic tricuspid valve disorders, unspecified</hc_keyword>
      <hc_keyword>Pulmonary valve disorders, unspecified</hc_keyword>
      <hc_keyword>Acute rheumatic heart disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The subjects in the intervention group are injected with 15mg/kg tranexamic acid plus 2 g(grams) fibrinogen (Haemocomplettan as the generic name). Afterwards, the length of stay in the ICU, mediastinal bleeding, use of blood products, intubation time in ICU, discharge conditions and mortality are registered for each subject. These drugs are intravenously injected in one session, immediately after mediastinal bleeding of more than 200 cc/hr. The last stage in non-responder patients is re-exploration.</i_keyword>
      <i_keyword>The second group consists of control subjects who receive 15 mg/kg tranexamic acid and routine care (including blood pressure control and use of blood products according to the paraclinical findings). The last stage in non-responder patients is re-exploration.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mediastinal bleeding. Timepoint: Conducted on an hourly basis for 48 hours from the time of ICU admission after surgery (before and after the intervention). Method of measurement: Registered in the questionnaire (cc/hour).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mortality. Timepoint: Measured daily during the hospital stay before and after the intervention. Method of measurement: Registered in the questionnaire according to patients percentage until discharge.</sec_outcome>
      <sec_outcome>ICU length of stay. Timepoint: The length of post-operative ICU stay before and after the intervention. Method of measurement: Registered in the questionnaire on a daily basis.</sec_outcome>
      <sec_outcome>Blood product usage (fresh frozen plasma, platelets, packed cells, whole blood). Timepoint: Registered every 4 hours for a 48 hours period, during the post-operative ICU stay (before and after the intervention). Method of measurement: Registered in the questionnaire according to the products bag.</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, Mashhad university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-02-07</approval_date>
        <contact_name>Ethics committee of Mashhad university of medical sciences</contact_name>
        <contact_address>Central building of Mashhad university of medical sciences, after Shahid Javan square, Shahid Fakoori street Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
