<?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>IRCT2017011631992N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-03-20</date_registration>
      <primary_sponsor>Shiraz University of Medical Science</primary_sponsor>
      <public_title>The effect of using sandbags and early mobilization on clot formation after  ablation catheter removal.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of using sandbags and early mobilization in reducing the  incidence of the hematoma and Subclinical deep vein thrombosis in patients undergoing cardiac radiofrequency catheter ablation .</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>225</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25023</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cardiac arrhythmias.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group 1, patients will receive in addition to routine care, intervention using the 2-pound sandbags for 2 hours on the catheter site will be on the groin. Intervention 2: The intervention group 2, in addition to usual care, after 4 hours of bed rest, will be out of bed. That first sitting bedside and then monitoring the vital signs  and blood pressure and pulse stability and the absence of complications such as bleeding and hematoma during 4 hours of bed rest, the patients will be out of bed and will walk. Intervention 3: In the control group, the patients after radiofrequency catheter ablation procedure, will receive usual care which includes complete bed rest in the supine position in the bed for 6 to 8 hours without shaking and bending and straightening the involved leg. Also in the first, the vital signs every 15 minutes to 1 hour, then every 30 minutes to 1 hour and then every 4 hours until discharge will be monitored and recorded in the form.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Abbasi Jondani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 1690, Taqi abedi Martyr st, Above neighborhood, Jondan, Ejhiye, Esfahan.</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8133146131</zip>
        <telephone>+98 31 4654 3029</telephone>
        <email>mabsmail23@gmail.com</email>
        <affiliation>Shiraz University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parisa Mansoori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazi sq. School of Nursing and Midwifery.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>mansoorip@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: candidates for Treatment of cardiac dysrhythmia using cardiac radiofrequency catheter ablation; willing to have cooperation in the project; radiofrequency catheter ablation through a vein procedure; age range should be between 18-70 years; systolic blood pressure less than 190 and diastolic blood pressure should be less than 110 mmHg.  Exclusion criteria: Unwillingness of participants to continue with the project; Existence of atrial fibrillation; Existence of bleeding disorder; history of deep vein thrombosis before the procedure; cardiac catheterization history over the past month; existence of risk factors causing the increase of deep vein thrombosis incidence such as complete bed rest; loss of consciousness; Existence of advanced heart failure (grade 3 or 4); receiving sedatives during and after the radiofrequency catheter ablation procedure (to avoid having a problem from getting out of bed); treatment with thrombolytic drugs under medical supervision; Extensive bleeding or any other complication such as dysrhythmia during and after the radiofrequency catheter ablation procedure.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I49</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other cardiac arrhythmias</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group 1, patients will receive in addition to routine care, intervention using the 2-pound sandbags for 2 hours on the catheter site will be on the groin.</i_keyword>
      <i_keyword>The intervention group 2, in addition to usual care, after 4 hours of bed rest, will be out of bed. That first sitting bedside and then monitoring the vital signs  and blood pressure and pulse stability and the absence of complications such as bleeding and hematoma during 4 hours of bed rest, the patients will be out of bed and will walk.</i_keyword>
      <i_keyword>In the control group, the patients after radiofrequency catheter ablation procedure, will receive usual care which includes complete bed rest in the supine position in the bed for 6 to 8 hours without shaking and bending and straightening the involved leg. Also in the first, the vital signs every 15 minutes to 1 hour, then every 30 minutes to 1 hour and then every 4 hours until discharge will be monitored and recorded in the form.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hematoma. Timepoint: Immediately after the departure of catheter sheaths and admission the patients in the ward and follow up them until discharge from the hospital. Method of measurement: Ruler of two-dimensional designed.</prim_outcome>
      <prim_outcome>Subclinical deep vein thrombosis. Timepoint: Immediately after discharge (24 hours after admission). Method of measurement: Doppler ultrasound.</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>Shiraz University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-03-12</approval_date>
        <contact_name>Shiraz University of Medical Science</contact_name>
        <contact_address>Headquarters of Shiraz University of Medical Science, Zand st Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
