<?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>IRCT2015091424018N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-11-14</date_registration>
      <primary_sponsor>Kurdistan University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of Coronary Angiography</public_title>
      <acronym></acronym>
      <scientific_title>The Comparative Study of the Effects of Sand Bag Keeping Time and Changing Body Position on Acute Complications of Coronary Angiography.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/20371</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>complication of cronary angiography.</hc_freetext>
      <i_freetext>Intervention 1: control group:&#13;
patients in the control group, will receive  routines care include of 8 hours motionless in supine position, with head angle of zero degrees, rest in bed and preserving a 4 kg sandbag on the site of catheter insertion for 6 hours. Intervention 2: sandbag’s intervention group:&#13;
patients in sandbag’s intervention group will receive  routines care except that in the third hour after entering to the heart ward, sandbag will be removed from the position. Intervention 3: Changing body Position’s intervention group:&#13;
patients in Changing body Position’s intervention group will receive  routines care except that the following positions during bed rest will be applied. During the first and second hours  supine position and head angle of zero degrees, during the third and fourth positions supine head angle of 45 degrees, during the fifth and sixth hours left and right latera position with head angle of 15 degrees and in the seventh and eighth in the sitting position will be cared for.</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>Sina Valiee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Number 4, Negin alley, Keshavarz town, Sanandaj</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00</telephone>
        <email>sinavaliee@yahoo.com</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parvin Mahmoodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Number7,Diman 4 alley, Hazhar street, Andishe town, Janbazan blv, Sanandaj, Kurdistan</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6616814915</zip>
        <telephone>+98 87 3328 0414</telephone>
        <email>mahmoodi.parvin@gmail.commahmoodi.parvin@muk.ac.irmahmoodi.parvin@yahoo.com</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: under non-emergency catheterization; age between 18-65 years; blood pressure less than 100/180 mmHg; the absence of active bleeding disorders; prothrombin time less than 16 seconds and time; Partial thromboplastin less than 90 seconds; no history of diabetes with disabilities; consent to participate in the study; angiography via the femoral artery; arterial puncture for the route only once; no DVT before the procedure; treatment with thrombolytic drugs and anticoagulant (taking warfarin); taking pain medication before the procedure; lack of peripheral vascular disease; no history of urinary problems; lack of sensitivity to contrast; no drug addiction; lack of chronic low back pain lack of blood and liver disease will be.&#13;
Exclusion criteria: active bleeding from the catheter entry with hemodynamic impairment and the need for blood transfusion; blood coagulation disorders; history of chronic low back pain; the need for cardiopulmonary resuscitation during angiography; chest pain with ECG changes; non-invasive blood pressure (NIBP) systolic or diastolic over and over mmHg 180 mmHg 100; disability and impaired level of consciousness in such a way that the patient is able to transform the work; rupture of the femoral artery during angiography; after a dangerous rhythm disorder Angiography; heparin injection during or after the procedure; the patient's hemodynamic status was while studying will be unhappy.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I70.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerosis of other arteries( coronary arteries)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>control group:&#13;
patients in the control group, will receive  routines care include of 8 hours motionless in supine position, with head angle of zero degrees, rest in bed and preserving a 4 kg sandbag on the site of catheter insertion for 6 hours.</i_keyword>
      <i_keyword>sandbag’s intervention group:&#13;
patients in sandbag’s intervention group will receive  routines care except that in the third hour after entering to the heart ward, sandbag will be removed from the position.</i_keyword>
      <i_keyword>Changing body Position’s intervention group:&#13;
patients in Changing body Position’s intervention group will receive  routines care except that the following positions during bed rest will be applied. During the first and second hours  supine position and head angle of zero degrees, during the third and fourth positions supine head angle of 45 degrees, during the fifth and sixth hours left and right latera position with head angle of 15 degrees and in the seventh and eighth in the sitting position will be cared for.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bleeding. Timepoint: at 0, 3, 6, 8 and 24 hours after angiography. Method of measurement: Measurement scales with a sensitivity of 0.1 g.</prim_outcome>
      <prim_outcome>Hematoma. Timepoint: at 0, 3, 6, 8 and 24 hours after angiography. Method of measurement: with Trans Parente and graph paper.</prim_outcome>
      <prim_outcome>Bruise. Timepoint: at 0, 3, 6, 8 and 24 hours after angiography. Method of measurement: with Trans Parente and graph paper.</prim_outcome>
      <prim_outcome>Pain( include of back pain and groin pain). Timepoint: at 0, 3, 6, 8 and 24 hours after angiography. Method of measurement: NRS.</prim_outcome>
      <prim_outcome>Urinary retention. Timepoint: at 0, 3, 6, 8 and 24 hours after angiography. Method of measurement: Based on asking from the patient.</prim_outcome>
      <prim_outcome>Convenience. Timepoint: at 0, 3, 6, 8 and 24 hours after angiography. Method of measurement: VAS.</prim_outcome>
      <prim_outcome>Thrombosis. Timepoint: at 0, 3, 6, 8 and 24 hours after angiography. Method of measurement: The sensory and motor symptoms, absence of peripheral pulse, the white appearance and painful physical examination.</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>Kurdistan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-09-30</approval_date>
        <contact_name>Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Kurdistan University of Medical Sciences,sanandaj, kurdistan sanandaj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
