<?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>IRCT20100919004775N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-18</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>effect of early deflation of  Trans Radial Band on vascular outcome after transradial coronary angiography</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effect of early deflation of  Trans Radial Band on vascular outcome after transradial coronary angiography in Alzahra hospital in Shiraz 2020</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44982</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The random allocation method in this study will be the permutation block method in that A represents the person receiving the intervention and B represents the person who does not receive the intervention.
This method is performed by considering 4 blocks so that the total number of 4 permutations is equal to 6.
(6 blocks including: ABAB, AABB, BABA, BBAA, ABBA and BAAB)
How to use the table of random numbers is that the starting point is selected randomly and 35 numbers are selected randomly (row or column) and the permutation assigned to each number is noted (the order of placement of permutations next to each other in order of Will be left to right) and how to allocate a total of 70 people to 2 groups A, B will be specified.</study_design>
      <phase>N/A</phase>
      <hc_freetext>coronary artery disease.</hc_freetext>
      <i_freetext>Intervention 1: In this study, the first observation of the control and control groups will be excluded. 35 people are considered for each group. In the control group, after angiography and removal of the sheet and closure of the trans radial band at the puncture site, the physician will inject 20 to 25 cc of air inside the trans radial band cafe. The cuff drain protocol in this group will be 5 thirty years after one and a half hours every quarter hour. At time zero, two hours, four hours, six hours after the sheet was removed in the hand undergoing angiography, hematoma and pain and obstruction were adjusted with the Esay scale to collect the horizontal line hematoma, which shows no need from zero to ten. Pain and pain are considered and the use of Allen test and pulse oximetry for obstruction is examined. Intervention 2: In this study, the first two observations of each of the control and control groups will be discarded. 35 people are considered for each group. In the control group, the cuff evacuation protocol is the same as the usual protocol in the angiography department.</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:
Information on the impact of the secondary outcome on the main outcome is published.

When:
One year after the results are published

To whom:
Participants in research and hospitals

Conditions:
To participants if they remain in the research until the last stage

Where to obtain:
Call 09173421740 or send an email to marjankarami60@gmail.com.

How to obtain:
By referring and sending a request to the email marjankarami60@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marjan Karami Khairabad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ferdowsi street</address>
        <city>Gachsaran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3567978</zip>
        <telephone>+98 71 3222 0078</telephone>
        <email>marjankarami60@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zinat Mohebbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sadra - Danesh Blvd. - Eram St. - Farhang St. in front of Farhang 3</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7199414477</zip>
        <telephone>26033641</telephone>
        <email>Mohebbi04@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men and women 18 years and older
Indication of diagnostic angiography, non-emergency treatment, and through the radial artery, as recommended by the physician.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any unexpected condition can lead to disruption of the care process such as myocardial infarction
Bleeding leads to surgeon intervention
Acute and chronic kidney disease
vascular problems (burger, diabetes)
Acute and chronic liver disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, the first observation of the control and control groups will be excluded. 35 people are considered for each group. In the control group, after angiography and removal of the sheet and closure of the trans radial band at the puncture site, the physician will inject 20 to 25 cc of air inside the trans radial band cafe. The cuff drain protocol in this group will be 5 thirty years after one and a half hours every quarter hour. At time zero, two hours, four hours, six hours after the sheet was removed in the hand undergoing angiography, hematoma and pain and obstruction were adjusted with the Esay scale to collect the horizontal line hematoma, which shows no need from zero to ten. Pain and pain are considered and the use of Allen test and pulse oximetry for obstruction is examined.</i_keyword>
      <i_keyword>In this study, the first two observations of each of the control and control groups will be discarded. 35 people are considered for each group. In the control group, the cuff evacuation protocol is the same as the usual protocol in the angiography department.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hematoma. Timepoint: Once every 15 minutes. Method of measurement: By Easy Scale.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Once every 15 minutes. Method of measurement: pain assessment tool.</prim_outcome>
      <prim_outcome>Obstruction. Timepoint: Once every 15 minutes. Method of measurement: Pulse oximeter - Allen test.</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 Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-02</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Ferdowsi Street - Sixth Alley Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
