<?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>IRCT20121229011923N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-18</date_registration>
      <primary_sponsor>Shoushtar  University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the efficacy of Clonidine and Tranexamic Acid on the volume of bleeding during rhinoplasty under general anesthesia: clinical trial</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the efficacy of Clonidine and Tranexamic Acid on the volume of bleeding during rhinoplasty under general anesthesia: clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>135</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37254</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: 135 people will be selected based on the formula for comparison of the meanings and randomly divided randomly into two groups of case (90) and a control group (45 people) based on the randomized quadruple randomization method. Then, the patients in the case group will be divided into two groups of Clonidine and Tranexamic Acid  (45) and  (45) by the reviewer, who will code the groups, Blinding description: In this study, the patients and the ENT surgeon will be unaware of the patient's group and the drugs. Only the investigator responsible for the study who is involved in the classification of the patients is aware.</study_design>
      <phase>3</phase>
      <hc_freetext>Evaluation of bleeding during nasal surgery.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: clonidine 3 micrograms per kilogram will be given orally 90 minutes before the surgery, and the amount of bleeding will be examined during surgery. Intervention 2: Second intervention group: Tranexamic Acid capsule 250 micrograms per kilogram body weight will be given to patients twice a day before surgery and the volume of bleeding will be examined during surgery. Intervention 3: Control group: The amount of bleeding will be checked without clonidine and Tranexamic Acid  medications.</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:
I do not know

When:
I do not know

To whom:
I do not know

Conditions:
I do not know

Where to obtain:
I do not know

How to obtain:
I do not know

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Akram Hemmatipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shoushtar University of Medical Sciences, West Rajaee Crossroads</address>
        <city>Shoushtar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6451984381</zip>
        <telephone>+98 61 3622 2221</telephone>
        <email>hematipour.a64@gmail.com</email>
        <affiliation>Shoushtar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Akram Hemmatipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shoushtar University of Medical Sciences, West Rajaee Crossroads</address>
        <city>Shoushtar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6451984381</zip>
        <telephone>+98 61 3622 2221</telephone>
        <email>hematipour.a64@gmail.com</email>
        <affiliation>Shoushtar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Conscious willingness to participate in research
Age between 18-60 years
Classification of the American Society of Anesthesiology in Class I and II: Class 1: includes patients with normal health who have no systemic problems, such as cardiovascular, respiratory, gastrointestinal, etc. Class 2: Includes a person with mild systemic disease and disease Is under control and has not caused any limitation for the patient)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Drug addiction, benzodiazepines, liver and kidney failure, diabetes, pulmonary and heart disease, coagulation disorders;
History of hypersensitivity to clonidine and Tranexamic Acid (increased blood pressure)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y44.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anticoagulants</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: clonidine 3 micrograms per kilogram will be given orally 90 minutes before the surgery, and the amount of bleeding will be examined during surgery.</i_keyword>
      <i_keyword>Second intervention group: Tranexamic Acid capsule 250 micrograms per kilogram body weight will be given to patients twice a day before surgery and the volume of bleeding will be examined during surgery.</i_keyword>
      <i_keyword>Control group: The amount of bleeding will be checked without clonidine and Tranexamic Acid  medications.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Evaluation of bleeding during nasal surgery. Timepoint: During and after nose surgery. Method of measurement: The size of the bleeding will be calculated based on the amount of bleeding accumulated in the suction and the blood-stained gases that will be weighed and the surgeon's vision.</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>Shoushtar  University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-14</approval_date>
        <contact_name>Ethics Committee of Shoushtar University of Medical Sciences</contact_name>
        <contact_address>Shoushtar University of Medical Sciences, West Rajaee Crossroads Shoushtar Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
