<?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>IRCT20240208060941N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-03-26</date_registration>
      <primary_sponsor>Pak-Emirates Military Hospital</primary_sponsor>
      <public_title>Eltrombopag and Platelet Recovery in Patients with Dengue Fever</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Eltrombopag Olamine on Platelet Recovery and Bleeding Complications Among Dengue Patients with Severe Thrombocytopenia_ A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79592</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We used simple randomization to ensure an unbiased and equal chance of assignment for all participants. The unit of randomization was the individual participant, ensuring that each subject’s assignment was unaffected by others. The random sequence was generated using a computer-based random number generator (RNG). Allocation concealment was strictly implemented to prevent selection bias. The randomization sequence was stored in a password-protected electronic file, and investigators enrolling participants had no prior access to assignment details, Blinding description: The participants, investigator, and healthcare providers (doctors and nurses) were blinded. Blinding was achieved by placing the drug (Eltrombopag Olamine) and the placebo in identical white capsules. The medications were prepared by a pharmacist in a separate room that was inaccessible to everyone else. The white capsules, labeled with patient IDs, were provided to the healthcare providers, who administered the medications to the patients according to the labeled IDs, thereby ensuring adherence to the blinding protocol.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Dengue Fever.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Tab Eltrombopag Olamine 25 mg will be given orally for 3 days once a day alongwith routine medical care. Intervention 2: Control group: Oral Glucose tablets will be given for 3 days once daily alongwith routine medical care as a placebo drug.</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:
The Deidentified Individual Participant Data Set, Study Protocol, Statistical Analysis Plan, and Informed
Consent forms will be made available to desirous researchers upon reasonable requests, and after clearance from the institutional data registry body. The said documents will be shared in a non-editable format via email after scrutinizing the need for subject documents by the requesting authorities

When:
The data will be available 6 months after the publication of the trial.

To whom:
The data will be available to researchers and teaching institutes for literary and educational purposes,

Conditions:
The data will be available for academic, research and literary purposes. Tt will not be available for commercial use.

Where to obtain:
The data can be obtained via Email from:
Dr Fatima Masud
Department of Medicine, Pak Emirates Military Hospital Rawalpindi
fatimamasud454@gmail.com

How to obtain:
Data will be made available on reasonable request, after approval from the data registry department of the institute.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatima Masud</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abid majeed road</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 335 2799000</telephone>
        <email>fatimamasud454@gmail.com</email>
        <affiliation>Pak-Emirates Military Hospital, Rawalpindi</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatima Masud</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abid majeed road</address>
        <city>Rawalpindi</city>
        <country1>Pakistan</country1>
        <zip>46000</zip>
        <telephone>+92 335 2799000</telephone>
        <email>fatimamasud454@gmail.com</email>
        <affiliation>Pak-Emirates Military Hospital, Rawalpindi</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adult patients
Dengue NS1 Positive
Platelet count less than 100</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>MP slide positive
Presence of any other warning signs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>A90</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dengue fever [classical dengue]</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: Tab Eltrombopag Olamine 25 mg will be given orally for 3 days once a day alongwith routine medical care.</i_keyword>
      <i_keyword>Control group: Oral Glucose tablets will be given for 3 days once daily alongwith routine medical care as a placebo drug</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Change in platelet counts. Timepoint: 7 Days after intervention. Method of measurement: Daily complete blood picture with manual platelet counts.</prim_outcome>
      <prim_outcome>Incidence of bleeding complications. Timepoint: Before intervention and daily for 7 days after invention. Method of measurement: Clinical monitoring.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Inflammatory markers. Timepoint: Day 7 of enrollment. Method of measurement: Serum Ferritin, Serum Albumin and Lipid profile will be monitored.</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>Pak-Emirates Military Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-10-24</approval_date>
        <contact_name>Ethical Review Committee, Pak Emirates Military Hospital, Rawalpindi</contact_name>
        <contact_address>Abid majeed road Rawalpindi Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
