<?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>IRCT20220103053614N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-30</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of heparin, reteplase and taurolock in the prevention of thrombosis in hemodialysis catheters</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of heparin, reteplase and taurolock in the prevention of thrombosis in hemodialysis catheters</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>185</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61066</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: . Despite the contingency of non-consecutive sampling, the samples are assigned in groups randomly. For assigning patients to 5 groups (four intervention groups and one control group), the stratified random allocation method is used. The classes are made based on the patient's age, patient's gender and duration of dialysis (8 classes in total). Within each floor, patients are assigned to groups using the method of random permutation blocks (five blocks) and with the tool of random number table, Blinding description: The patient, the thrombus evaluator and the statistical analyst do not know the type of intervention performed on the patient. It should be noted that neither the thrombus assessor nor the decoder are members of the research team.</study_design>
      <phase>3</phase>
      <hc_freetext>Thrombosis in dialysis catheters.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Injection of high dose heparin (1000 units) plus 2 cc of distilled water to the number of dialysis patients per week in both lines of hemodialysis catheter. Intervention 2: Intervention group: Low dose heparin injection (50 units) plus 2 cc of distilled water to the number of dialysis patients per week in both lines of hemodialysis catheter. Intervention 3: Intervention group: Injection of Taurolack ampoule 5 mg plus 2 cc of distilled water to the number of dialysis patients per week in both lines of hemodialysis catheter. Intervention 4: Intervention group: Injection of Reteplase 1 mg plus 2 cc of distilled water to the number of dialysis patients per week in both lines of hemodialysis catheter. Intervention 5: Control group: Heparin according to the patient's routine (5,000 units) plus 2 cc of distilled water in each catheter line the number of times dialysis per week.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Coordination with the tutor and consultants at the end of the study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>azadeh razian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kia building, Valiasr alley, Maharat boulevard, 60 meters boulevard</address>
        <city>khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6817362060</zip>
        <telephone>+98 66 3324 3965</telephone>
        <email>azadeh.r697@yahoo.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>azadeh razian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kia building,Valiasr alley, Maharat boulevard, 60 meters boulevard</address>
        <city>khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6817362060</zip>
        <telephone>+98 66 3324 3965</telephone>
        <email>azadeh.r697@yahoo.com</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Dialysis patients with catheter (premict)
Patient satisfaction</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No premix catheter for dialysis
Mentioning the history of allergies to the intervened drugs
Lack of awareness to obtain satisfaction</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>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_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: Injection of high dose heparin (1000 units) plus 2 cc of distilled water to the number of dialysis patients per week in both lines of hemodialysis catheter</i_keyword>
      <i_keyword>Intervention group: Low dose heparin injection (50 units) plus 2 cc of distilled water to the number of dialysis patients per week in both lines of hemodialysis catheter</i_keyword>
      <i_keyword>Intervention group: Injection of Taurolack ampoule 5 mg plus 2 cc of distilled water to the number of dialysis patients per week in both lines of hemodialysis catheter</i_keyword>
      <i_keyword>Intervention group: Injection of Reteplase 1 mg plus 2 cc of distilled water to the number of dialysis patients per week in both lines of hemodialysis catheter</i_keyword>
      <i_keyword>Control group: Heparin according to the patient's routine (5,000 units) plus 2 cc of distilled water in each catheter line the number of times dialysis per week</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Thrombosis in dialysis catheters. Timepoint: At the beginning of the study and six months after the intervention. Method of measurement: Successful full dialysis during routine dialysis sessions.</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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-08</approval_date>
        <contact_name>Ethics Committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Kia building, Valiasr alley, Maharat boulevard, 60 meters boulevard, khorramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
