<?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>IRCT201604138650N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-06-05</date_registration>
      <primary_sponsor>Baqiyatallah University of Medical Sciences</primary_sponsor>
      <public_title>Outcomes of removal of arterial sheath in patients with angioplasty</public_title>
      <acronym></acronym>
      <scientific_title>The effect of evidence based practice on outcomes after removal of arterial sheath in patients with angioplasty</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9142</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The objectives of the study were explained to the patients and informed consent was obtained. Then according to the inclusion criteria, patients were randomly assigned based on random-number table to intervention (n =100) and control group (n=100). Then, in control group according to the conventional methods and in intervention group based on the new designed guideline, removal of the arterial sheath and then outcomes (vasovagal, bleeding, hematoma, urine retention and back pain ) are recorded.</study_design>
      <phase>3</phase>
      <hc_freetext>Coronary Artery disease.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group, removal of the arterial sheath and clinical care were based on the following protocol.&#13;
1. Control of ACT in the third hour after angioplasty&#13;
2. If ACT was less than or equal to 175, the arterial sheath would be removed by manual compression.&#13;
3. Put direct pressure on the arterial sheath insertion site for two to three minutes so that the dorsalis pedis pulse disappears. Then lower the pressure to feel the dorsalis pedis pulse. Continue pressuring until hemostasis (10 to 20 minutes).&#13;
4. Put pressure dressing on arterial sheath area by a trained doctor or nurse.&#13;
5. Put two sandbags (4 kg weight per bag) on the dressing by nurse&#13;
6. Remove the first and the second sandbags two and three hours after removing the arterial sheath, respectively.&#13;
7. Patients were out of bed three hours after removal of the arterial sheath in case of no complication.&#13;
&#13;
8. Record outcomes of removal of the arterial sheath in the data record form (all outcomes during the removal and up to one day after that were recorded). Intervention 2: In control patients, the arterial sheath was removed 4 to 6 hours after angioplasty, and then the manual compression was used for hemostasis. Two 8 kg sandbags compressed the dressing position. The first and second sandbags were removed two hours and 4-6 hours after removing the arterial sheath, respectively. Patients were out of bed 6 hours after removing the arterial sheath. Finally, outcomes of removing the arterial sheath, during this procedure and up to one day after that, were logged in the data record 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>Ali reza paraj</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baqiyatallah Hospital,mollasadra Ave,Vanak Sq,Tehran,Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435915371</zip>
        <telephone>+98 21 8126 3596</telephone>
        <email>rezaparaj300@gmail.com</email>
        <affiliation>School of nursing, Baqiyatallah University of Medical Sciences, Tehran, Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Abbas Ebadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of nursing, Baqiyatallah University of Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19575174</zip>
        <telephone>+98 88040060</telephone>
        <email>ebadi1347@yahoo.com</email>
        <affiliation>Baqiyatallah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria:&#13;
1- patient does not have  hemodialysis&#13;
2-patients who do not require  emergency percutaneous Transluminal coronary Angioplasty(PTCA)     &#13;
&#13;
exclusion criteria:&#13;
1-  patients who for any reason had a sudden increase in serum creatine that were leading to hemodialysis &#13;
&#13;
2- patients who developed severe hemorrhage in the arterial sheath place and returned to cath lab.</inclusion_criteria>
      <agemin>42 years</agemin>
      <agemax>89 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>ischemic heart disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group, removal of the arterial sheath and clinical care were based on the following protocol.&#13;
1. Control of ACT in the third hour after angioplasty&#13;
2. If ACT was less than or equal to 175, the arterial sheath would be removed by manual compression.&#13;
3. Put direct pressure on the arterial sheath insertion site for two to three minutes so that the dorsalis pedis pulse disappears. Then lower the pressure to feel the dorsalis pedis pulse. Continue pressuring until hemostasis (10 to 20 minutes).&#13;
4. Put pressure dressing on arterial sheath area by a trained doctor or nurse.&#13;
5. Put two sandbags (4 kg weight per bag) on the dressing by nurse&#13;
6. Remove the first and the second sandbags two and three hours after removing the arterial sheath, respectively.&#13;
7. Patients were out of bed three hours after removal of the arterial sheath in case of no complication.&#13;
&#13;
8. Record outcomes of removal of the arterial sheath in the data record form (all outcomes during the removal and up to one day after that were recorded).</i_keyword>
      <i_keyword>In control patients, the arterial sheath was removed 4 to 6 hours after angioplasty, and then the manual compression was used for hemostasis. Two 8 kg sandbags compressed the dressing position. The first and second sandbags were removed two hours and 4-6 hours after removing the arterial sheath, respectively. Patients were out of bed 6 hours after removing the arterial sheath. Finally, outcomes of removing the arterial sheath, during this procedure and up to one day after that, were logged in the data record form.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Vasovagal. Timepoint: During and after removal the arterial sheath. Method of measurement: check list.</prim_outcome>
      <prim_outcome>Bleeding. Timepoint: ِDuring  and after removal the arterial sheath. Method of measurement: check list.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hematoma. Timepoint: After removal the arterial sheath. Method of measurement: Check list.</sec_outcome>
      <sec_outcome>Urine retention. Timepoint: After removal the arterial sheath. Method of measurement: Check list.</sec_outcome>
      <sec_outcome>Back pain. Timepoint: After removal the arterial sheath. Method of measurement: Check list.</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>Baqiyatallah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-04-30</approval_date>
        <contact_name>ٍEthics commitee of Baqiyatallah University of Medical sciences</contact_name>
        <contact_address>6th Floor, Nursing Faculty, Baqiyatallah University of Medical Sciences, P.O.Box: 19575174 Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
