<?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>IRCT20240215061017N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-12</date_registration>
      <primary_sponsor>CMH Lahore Medical College</primary_sponsor>
      <public_title>Usefulness of desmopressin in reducing bleeding during insertion of tunneled dialysis catheters</public_title>
      <acronym></acronym>
      <scientific_title>Hemostatic effectiveness of intranasal desmopressin for tunneled dialysis catheter placement</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-02-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81558</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individual patients would be randomized into two groups using sequences generated online before the patient enrollment gets started. This randomization list will be kept with the Principal Investigator. All doctors performing the catheter insertion procedures would contact him personally to check which arm each successive patient is to be randomized to.</study_design>
      <phase>N/A</phase>
      <hc_freetext>end stage renal disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in this group would be given a single puff of desmopressin in each nostril, 30 minutes before the insertion of tunneled dialysis catheters. After half an hour, catheters would be inserted in such patients. Intervention 2: Control group: Patients in this group will not receive any intervention. Catheters would be inserted straight away.</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:
Individual patient data would be shared on Harvard Dataverse once the study is published in a biomedical journal

When:
After publication of paper in a biomedical journal

To whom:
For anyone who may be interested

Conditions:
No restrictions

Where to obtain:
By emailing the PI

How to obtain:
Request forwarded by email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abdul Rehman Arshad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abdur Rehman Road, Lahore Cantonment</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54810</zip>
        <telephone>+92 335 6746747</telephone>
        <email>maj.abdulrehman@gmail.com</email>
        <affiliation>CMH Lahore Medical College</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abdul Rehman Arshad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abdur Rehman Road, Lahore Cantonment</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54810</zip>
        <telephone>+92 335 6746747</telephone>
        <email>maj.abdulrehman@gmail.com</email>
        <affiliation>CMH Lahore Medical College</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>End stage renal disease requiring insertion of tunneled dialysis catheter</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Current use of anticoagulants
Platelets count &lt;50,000/µl
Previous tunneled dialysis line insertions at the same site
Blood pressure &gt;180/110 mmHg
Unwillingness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.6</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>End stage renal disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients in this group would be given a single puff of desmopressin in each nostril, 30 minutes before the insertion of tunneled dialysis catheters. After half an hour, catheters would be inserted in such patients.</i_keyword>
      <i_keyword>Control group: Patients in this group will not receive any intervention. Catheters would be inserted straight away.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bleeding from the catheter exit site. Timepoint: Within 24 hours of the intervention. Method of measurement: Visual inspection and reporting by the patients.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Need for intervention to control bleeding from catheter exit site. Timepoint: Within 24 hours of the interventon. Method of measurement: Review of medical records.</sec_outcome>
      <sec_outcome>New onset headache (side effect). Timepoint: Within 24 hours of intervention. Method of measurement: Direct inquiry from the patient.</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>CMH Lahore Medical College</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-02-06</approval_date>
        <contact_name>Research Review Board, Combined Military Hospital Lahore</contact_name>
        <contact_address>Abdul Rehman Road, Lahore Cantonment Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
