<?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>IRCT20191020045166N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-17</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Nursing Interventions on the Preventing Hypotension in Patients Undergoing Plasmapheresis</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effects of Wearing of Elastic Socks with Leg Elevation on preventing Hypotension in patients undergoing Plasmapheresis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43328</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be grouped by permutation blocks, So that each combination of ABCD, BCAD, CDAB and DABC will be placed in a separate envelope to the same count of patient so at first we select a patient who chooses an envelope randomly; for example if ABCD sequence is selected, method A will be run at first then B and respectively C and D.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Prevention of Hypotension due to Plasmapheresis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A: In addition to receiving routine care, the patient also uses elastic socks; at the beginning of the plasmapheresis session, the patient wears elastic socks and is maintained until the end of the session, Also at the start, during and after the intervention, the patient's blood pressure and pulse are recorded. Intervention 2: Intervention group B: In addition to receiving routine care, the patient's legs are raised 45 degrees at the start of the session and this position is maintained until the end of the plasmapheresis and the patient's blood pressure and pulse rate are recorded during the session. Intervention 3: Intervention group C: At the beginning of plasmapheresis, elastic socks are used to raise the legs 45 degrees simultaneously until the end of the session and the patient's blood pressure and pulse are recorded during plasmapheresis. Intervention 4: Control group: The patient does not receive any intervention and only the routine care for patients during plasmapheresis will be implemented and the patient's blood pressure and pulse are recorded during the session.</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 Publication of information is subject to permission from Hamedan University of Medical Sciences.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Armin Mohamadiparsa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No20, Meraj street, Amirkabir</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6515819173</zip>
        <telephone>+98 81 3272 7710</telephone>
        <email>armin94g@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Armin Mohamadiparsa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No20, Meraj street, Amirkabir</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6515819173</zip>
        <telephone>+98 81 3272 7710</telephone>
        <email>armin94g@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients undergoing plasmapheresis for at least 4 sessions with at least one day interval
Age 20 to 60 years
The minimum volume of plasma separation should be 1.5 liters
The duration of plasmapheresis is between 3 and 4 hours
Patient alertness</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cardiovascular disease and severe anemia
Use of medications that affect blood pressure over the past 24 hours
Any prohibition on measuring blood pressure and upper limb pulse
Any prohibition on wearing elastic socks or lifting legs
Pregnancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I95</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypotension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group A: In addition to receiving routine care, the patient also uses elastic socks; at the beginning of the plasmapheresis session, the patient wears elastic socks and is maintained until the end of the session, Also at the start, during and after the intervention, the patient's blood pressure and pulse are recorded.</i_keyword>
      <i_keyword>Intervention group B: In addition to receiving routine care, the patient's legs are raised 45 degrees at the start of the session and this position is maintained until the end of the plasmapheresis and the patient's blood pressure and pulse rate are recorded during the session.</i_keyword>
      <i_keyword>Intervention group C: At the beginning of plasmapheresis, elastic socks are used to raise the legs 45 degrees simultaneously until the end of the session and the patient's blood pressure and pulse are recorded during plasmapheresis.</i_keyword>
      <i_keyword>Control group: The patient does not receive any intervention and only the routine care for patients during plasmapheresis will be implemented and the patient's blood pressure and pulse are recorded during the session</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood Pressure. Timepoint: Before starting the process and then at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours and finally half an hour after the end. Method of measurement: Portable Blood Pressure Monitor.</prim_outcome>
      <prim_outcome>Pulse Rate. Timepoint: Before starting the process and then at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4 hours and finally half an hour after the end. Method of measurement: Pulse Oximeter Device.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-28</approval_date>
        <contact_name>Ethics Committee of Hamedan University of Medical Sciences</contact_name>
        <contact_address>Fahmide Street, Hamedan University of Medical Sciences Hamedan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
