<?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>IRCT2015092824241N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-11-07</date_registration>
      <primary_sponsor>Vice Chancellor for Research of Ahvaz Jundishapur University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Tranexamic Acid On intraoperative Bleeding</public_title>
      <acronym>-</acronym>
      <scientific_title>Evaluating the effect of intravenous tranexamic acid on intraoperative bleeding during elective rhinoplasty surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-10-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20514</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: A statistician not otherwise involved in the study provides the randomization sequence using an electronic random number generator (Microsoft Excel Program). Allocation letters are sealed using envelopes in which tranexamic acid or normal saline solutions are provided which look indistinguishable.</study_design>
      <phase>2</phase>
      <hc_freetext>Intraoperative Bleeding during Rhinoplasty.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: Study subjects in the treatment arm will be administered with a bolus intravenous dose of tranexamic acid (10 milligram  per kilogram, Caspian – Tamin Pharmaceutical Company, Rasht, Iran) which is transfused slowly after anesthesia induction. Anesthesia is attempted similarly for all patients. Briefly, propofol 2 milligram per kilogram (mg/kg) and fentanyl 1 micro-gram per kilogram are transfused with the aim of induction. Intravenous Atracurium (0.5 mg/kg) is infused to facilitate orotracheal intubation and anesthesia will be maintained using isoflurane inspired at a flow rate of 5 liters per minute in combination with air 30% in oxygen. Intravenous neostigmine 0.04 mg/kg and atropine 0.01 mg/kg will be used to reverse neuromuscular blockage at the end of operation. Intervention 2: Control Group: Subjects in the control group will receive normal saline as the placebo. Anesthesia is attempted similarly for all patients. Briefly, propofol 2 milligram per kg and fentanyl 1 micro-gram per kilogram are transfused with the aim of induction. Intravenous Atracurium (0.5 mg/kg) is infused to facilitate orotracheal intubation and anesthesia will be maintained using isoflurane inspired at a flow rate of 5 liters per minute in combination with air 30% in oxygen. Intravenous neostigmine 0.04 mg per kg and atropine 0.01 mg per kg will be used to reverse neuromuscular blockage at the end of operation.</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>Ali Ghazipoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Ear Nose and Throat Surgery, Imam Khomeini Hospital, Azadegan Avenue</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61133809012</telephone>
        <email>Dr.aghp@yahoo.com</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Ghazipoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Ear Nose and Throat Surgery, Imam Khomeini Hospital, Azadegan Avenue</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61133809012</telephone>
        <email>Dr.aghp@yahoo.com</email>
        <affiliation>Ahvaz Jundishapur University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Normotensive patients scheduled for elective open rhinoplasty aged 16-42 years without a history of bleeding diathesis with ASA (American Society of Anesthesiologists) class of either I or II. Exclusion Criterai: patients with uncontrolled hypertension; history of hypersensitivity to tranexamic acid; brain vascular diseases; coronary artery diseases; cardiac dysrhythmia; liver/kidney or metabolic disorders; patients with ASA class of either III or IV.</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>42 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: Study subjects in the treatment arm will be administered with a bolus intravenous dose of tranexamic acid (10 milligram  per kilogram, Caspian – Tamin Pharmaceutical Company, Rasht, Iran) which is transfused slowly after anesthesia induction. Anesthesia is attempted similarly for all patients. Briefly, propofol 2 milligram per kilogram (mg/kg) and fentanyl 1 micro-gram per kilogram are transfused with the aim of induction. Intravenous Atracurium (0.5 mg/kg) is infused to facilitate orotracheal intubation and anesthesia will be maintained using isoflurane inspired at a flow rate of 5 liters per minute in combination with air 30% in oxygen. Intravenous neostigmine 0.04 mg/kg and atropine 0.01 mg/kg will be used to reverse neuromuscular blockage at the end of operation.</i_keyword>
      <i_keyword>Control Group: Subjects in the control group will receive normal saline as the placebo. Anesthesia is attempted similarly for all patients. Briefly, propofol 2 milligram per kg and fentanyl 1 micro-gram per kilogram are transfused with the aim of induction. Intravenous Atracurium (0.5 mg/kg) is infused to facilitate orotracheal intubation and anesthesia will be maintained using isoflurane inspired at a flow rate of 5 liters per minute in combination with air 30% in oxygen. Intravenous neostigmine 0.04 mg per kg and atropine 0.01 mg per kg will be used to reverse neuromuscular blockage at the end of operation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Estimated amount of intraoperative bleeding. Timepoint: During surgery (starting from the incision till wound closure). Method of measurement: The volume of blood suctioned during a surgery is calculated by subtracting the amount of irrigation fluid used during a surgery from the total amount of fluid gathered in suction canister at the end of surgery. The volume of blood absorbed by 4*4 inch gauzes during an operation is calculated by multiplying the number of gauzes completely soaked with blood by 10 milliliters (an estimated average of blood absorbed per gauze). These two values are then added to estimate the total intraoperative volume of blood loss.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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 of Ahvaz Jundishapur University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-06-06</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundishapour University of Medical Sciences</contact_name>
        <contact_address>Ethics Committee, It &amp; Research Assistance Center, University complex, Golestan Highway Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
