<?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>IRCT20170807035554N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-21</date_registration>
      <primary_sponsor>Taleghani Hospital Research Development committee</primary_sponsor>
      <public_title>The effect of thromboprophylactic drugs on post-operative complications of arthroscopic ACL surgery</public_title>
      <acronym></acronym>
      <scientific_title>The effect of thromboprophylactic drugs on post-operative complications of arthroscopic ACL reconstruction surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>138</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/48718</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization for 2 intervention groups an 1 control group. The randomization method will done using software, 46 random numbers for each intervention group. 
The researcher can not play a role in predicting treatment of the disease, and choosing the type of treatment. random sequence will generate by software. 
َAll 138 Admitted individuals fall into one of three groups according to a predetermined code, Blinding description: In this study, blinding is performed at three levels: patient, physician, and data analyzer; So that the drugs are packaged and coded in dark paper packages. As a result, the patient, physician, and person in charge of the analysis are not informed of the type of medication prescribed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>post-operative complications of arthroscopic ACL reconstruction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: (1) start up 80 mg aspirin daily for 14 days. Intervention 2: Intervention group: (2) prescribed SQ injection of enoxapirin 40 for 14 days. Intervention 3: Control: receive none of anticoagulant drug as a control group.</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:
All data can be shared potentially after patients became unrecognizable

When:
After completing the results and analyzing the data, access to them is allowed

To whom:
This is only available for people working in academic institutions

Conditions:
This is only available for people working in academic institutions

Where to obtain:
After obtaining written permission, the use of the data is permitted with reference to the source. Dr Mohammadreza Sajjadi, 09123377215

How to obtain:
After completing the results and analyzing the data, the use of the data is allowed after the written request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammadreza Minator Sajjadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani hospital, next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985711151</zip>
        <telephone>+98 21 2240 2020</telephone>
        <email>arashsajadi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadreza Minator Sajjadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani hospital, next to Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985711151</zip>
        <telephone>0098 22402020</telephone>
        <email>arashsajadi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients between 18 and 45 years old
Patient with ACL rupture diagnosed in MRI Entered the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with other ligament injuries in addition to ACL
Patients with concomitant damage in the same side long osseous
Patients who need other procedures that interfer With rehabilitation after surgery
Having a history of DVT
Patient who were under thromboprophylaxis before surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S83.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Injury to multiple structures 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: (1) start up 80 mg aspirin daily for 14 days</i_keyword>
      <i_keyword>Intervention group: (2) prescribed SQ injection of enoxapirin 40 for 14 days</i_keyword>
      <i_keyword>Control: receive none of anticoagulant drug as a control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Deep vein thrombosis (DVT). Timepoint: 14 and 28 days after surgery. Method of measurement: ٍWith examination and Doppler ultrasound.</prim_outcome>
      <prim_outcome>Venous thromboembolism (VTE). Timepoint: 14 and 28 days after surgery. Method of measurement: with contrast methods and computed tomography (ct angiography).</prim_outcome>
      <prim_outcome>Hemarthrosis and opioids. Timepoint: 14 and 28 days after surgery. Method of measurement: Examination methods and score according to the stroke table.</prim_outcome>
      <prim_outcome>Intraspinal bleeding. Timepoint: 14 and 28 days after surgery. Method of measurement: Examination.</prim_outcome>
      <prim_outcome>Operative bleeding. Timepoint: 14 and 28 days after surgery. Method of measurement: Examination.</prim_outcome>
      <prim_outcome>Retroperitoneal bleeding. Timepoint: 14 and 28 days after surgery. Method of measurement: Examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Shahid Beheshti University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Taleghani Hospital Research Development committee</source_name>
      <source_name>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-11-09</approval_date>
        <contact_name>Shahid Beheshti university of medical science</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciences, Yemen St., Arabi St., Chamran Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
