<?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>IRCT20230428058015N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-16</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of normal flushing of heparinized saline with subcutaneous injection of enoxaparin with a prophylactic dose in preventing central venous catheter thrombosis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of heparinized normal saline flushing with prophylactic dose enoxaparin subcutaneous injection in the prevention of central venous catheter thrombosis in hospitalized high-risk patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69823</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients divided into two groups using Permuted Block Randomization. In this way, the two-block modes (AB, BA) are randomly assigned to each treatment order using a random number table and the placement of the two blocks.</study_design>
      <phase>3</phase>
      <hc_freetext>Vein thrombosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Flushing 2 cc of heparinized normal saline with a concentration of 2 units of heparin per cc every 8 hours after central venous catheter insertion. Intervention 2: Intervention group: Subcutaneous injection of enoxaparin at a dose of 0.5 mg/kg every 12 hours after central venous catheter insertion.</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 potential data is shared after unidentifiable people

When:
Start accessing 6 months after printing results

To whom:
It will only be available to researchers working in academic and scientific institutions

Conditions:
For use in congress as a scientific document

Where to obtain:
Dr. Maryam Mohebbi by email: 
dr.m.mhb@gmail.com

How to obtain:
As soon as the applicant requests to receive the documents, the data will be provided to them within two to three days
email: dr.m.mhb@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Mohebbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahrami Pediatric Hospital, Kiyaei St., Damavand St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1641744991</zip>
        <telephone>+98 21 7756 8801</telephone>
        <email>dr.m.mhb@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Mohebbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahrami Pediatric Hospital, Kiyaei St., Damavand St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1641744991</zip>
        <telephone>+98 21 7756 8801</telephone>
        <email>dr.m.mhb@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with central venous catheter admitted to the intensive care unit
None of the bleeding risk factors
Informed consent of the patient's parent or guardian to participate in the study
Age one month to 18 years</inclusion_criteria>
      <agemin>1 month</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Risk factors of central venous catheter thrombosis
Anti-coagulant or anti-platelet medication use in the past 5 days
Major surgery in the last 24 hours
Glomerular filtration rate less than 30
Thrombocytopenia (platelets less than 50 thousand)
Kidney, heart and liver disorders
Uncontrolled blood pressure
Lumbar puncture in the last 24 hours</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I81</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Portal vein thrombosis</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>Intervention group: Flushing 2 cc of heparinized normal saline with a concentration of 2 units of heparin per cc every 8 hours after central venous catheter insertion.</i_keyword>
      <i_keyword>Intervention group: Subcutaneous injection of enoxaparin at a dose of 0.5 mg/kg every 12 hours after central venous catheter insertion.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Thrombosis. Timepoint: At the beginning of the study, 4 and 30 days after the intervention. Method of measurement: ultrasound.</prim_outcome>
      <prim_outcome>Sepsis. Timepoint: At the beginning of the study, 4 and 30 days after the intervention. Method of measurement: Patient symptoms based on systemic inflammatory response syndrome.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: At the beginning of the study, 4 and 30 days after the intervention. Method of measurement: Arterial pulse taking.</prim_outcome>
      <prim_outcome>Body Tempretute. Timepoint: At the beginning of the study, 4 and 30 days after the intervention. Method of measurement: Thermometer.</prim_outcome>
      <prim_outcome>Respiration rate. Timepoint: At the beginning of the study, 4 and 30 days after the intervention. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Hemoglobin. Timepoint: At the beginning of the study, 4 and 30 days after the intervention. Method of measurement: ELISA Kit.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-29</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Markazi Building, Qods St., Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
