<?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>IRCT20160809029286N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-29</date_registration>
      <primary_sponsor>Joint Reconstruction Research Center</primary_sponsor>
      <public_title>Intra-articular vs Intravenous vs  combine IVIA Tranexamic Acid in total knee arthroplasty</public_title>
      <acronym></acronym>
      <scientific_title>Intra-articular vs Intravenous vs  combine IVIA Tranexamic Acid in total knee arthroplasty patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>147</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47313</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: For randomization, the permuted balanced blocks method was used. In this method, six balanced blocks (1 to 6) were defined regarding the three interventions of the study (A, B, C) including BAC, ACB, ABC, CAB, BCA and CBA . The patients were divided into 49 groups of three patients. The patients’ numbers were inserted from 1 to 147 in a column using MS Excel software. In another column, the group of each patient was inserted, for example: patients 1 to 3 as group 1, patients 4 to 6 as group 2, …, patients 144 to 147 as group 49. In another Excel sheath, the groups were inserted from 1 to 49, and the blocks were inserted across each group from 1 to 6 in order till the end. In the next column, non-repeated random numbers were inserted using the “RANDL()” command. Subsequently, the order of the blocks was randomly changed. According to the block assigned with each group, the intervention regarding each patient was determined. For example, if group 1 is assigned with “CAB”, the interventions were as follows: Patient 1, C; Patient 2, A; Patient 3, B, Blinding description: During the injection of tranexamic acid, the person who does the injection hadn't any information about the study. Patients are not aware of the medication model of injection. Patients are divided into groups by random code designed by the researcher and identified with the patient ID at the time of analysis.</study_design>
      <phase>3</phase>
      <hc_freetext>Blood Loss after Total Knee Arthroplasty.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 15 mg/kg TXA intra-Articular injection post-operative. Intervention 2: Intervention group:  15 mg/kg TXA intravenous injection before the surgery and performing tourniquet. Intervention 3: Intervention group:  TXA was injected in combination of postoperative intra-Articular and preoperative intravenous methods and 15 mg/kg for each method.</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:
En At the end of the study, All data Except Demographics will be published.

When:
July 2020

To whom:
Orthopedic Surgeons

Conditions:
There are no special conditions

Where to obtain:
Anyone can request study data by sending an email to the plan executor (َAlireza Moharrami).

How to obtain:
Within 2 weeks will be answered

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Moharrami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Orthopaedic Ward, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran , IRAN</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6119 2767</telephone>
        <email>a-moharrami@student.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Seyed Mohammad Javad Mortazavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Orthopaedic Ward, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6653 1354</telephone>
        <email>smjmort@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Total knee arthroplasty candidate patients
Surgery in Imam Khomeini Hospital
Not having a specific bleeding disorder
Not having any co-morbidity
Not having any cardiovascular diseases
Accept the terms of participation in the study voluntarily</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cardiovascular diseases
Any co-morbidity
Any bleeding disorders
Thromboembolie and stroke history
Not voluntary
Sensitivity to tranexamic acid
Revision TKA</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of knee</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>Intervention group: 15 mg/kg TXA intra-Articular injection post-operative</i_keyword>
      <i_keyword>Intervention group:  15 mg/kg TXA intravenous injection before the surgery and performing tourniquet</i_keyword>
      <i_keyword>Intervention group:  TXA was injected in combination of postoperative intra-Articular and preoperative intravenous methods and 15 mg/kg for each method</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post-operative Hb to pre-operative Hb. Timepoint: Pre-operative, 24 hour post-operative, 48 hour post-operative, 72 hour post-operative. Method of measurement: With blood lab test and blood loss calculation with GOOD &amp; NADLER formulae.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Occurrence of vascular thrombosis, DVT, Stroke and embolism. Timepoint: At least two years Follow-up. Method of measurement: Physical exam and para-clinics.</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>Joint Reconstruction Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-15</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Science</contact_name>
        <contact_address>mam Khomeini Hospital, End of Keshavarz blvd, Keshavarz Blvd, Tehran tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
