<?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>IRCT20221030056340N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-07</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>"Effect of Ice Compress on Hematoma Control"</public_title>
      <acronym></acronym>
      <scientific_title>The effect of ice packs on hematoma prevention in radial artery angiography in patients with acute coronary syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66628</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sealed Envelope online site will be used for the randomization process. Regarding the method of randomization, at the beginning of the study, using the above site, a random sequence of 120 cases was generated using the block method, which included 60 intervention cases and 60 control cases, and this list was kept with the epidemiologist colleague (consultant professor).After examining the entry criteria of each participant, and their eligibility, to decide on the placement of that person in each of the groups, the student contacted the advisor and based on the randomization sequence list for that person. A decision will be made.This procedure will be done for all participants (120 people) until the end, which will lead to the division of people into two completely equal and random groups, and this will keep the random sequence hidden from the patient (student), which shows the concept of concealment. Or Concealment is random in the allocation process. In addition, as mentioned above, the selection of each of 120 people for the intervention and control groups is based on the randomization sequence list and with the opinion of the epidemiologist (consultant professor).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Radial Artery Angiography.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In order to perform the intervention, an ice compress (from Sarma Zar company) with dimensions of 10 x 5 cm, weighing 100 grams and covered with sterile gauze, in two stages, the first stage before removing the cuffed transparent bracelet and the second stage The cuffed transparent bracelet will be used immediately after leaving. In each stage, the duration of using the ice compress will be twenty minutes. Before and after the intervention, hematoma formation or non-formation, its dimensions and diameter will be measured. Intervention 2: Control group: Holding up the arm undergoing radial angiography.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahboubeh Rajabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.20 , Moallem Ave., Vincheh</address>
        <city>Mobarakeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8499115431</zip>
        <telephone>+98 31 5245 2650</telephone>
        <email>mahbob.r72@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ameneh Yaghoobzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij Square, Arak University of Medical SciencesMarkazi Province</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848176941</zip>
        <telephone>+98 86 3417 3526</telephone>
        <email>A.Yaghoobzadeh@arakmu.ac.ir</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ability to Give Informed Consent
Age 18-80 Years
Radial Angiography and Having a Clear Cuffed Bracelet
Platelets within the normal range
INR&lt;1.8
Not having Coagulation Problems
No Addiction
No History of Angiography in the Past Year
Not Receiving Streptokinase or Retplase in the Last Three Months
Not Sensitive to Cold</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unusual Bleeding from the Angiographic Site
Non-cooperation and Withdrawal from the Study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I97.610</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postprocedural hemorrhage and hematoma of a circulatory system organ or structure following a cardiac catheterization</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In order to perform the intervention, an ice compress (from Sarma Zar company) with dimensions of 10 x 5 cm, weighing 100 grams and covered with sterile gauze, in two stages, the first stage before removing the cuffed transparent bracelet and the second stage The cuffed transparent bracelet will be used immediately after leaving. In each stage, the duration of using the ice compress will be twenty minutes. Before and after the intervention, hematoma formation or non-formation, its dimensions and diameter will be measured.</i_keyword>
      <i_keyword>Control group: Holding up the arm undergoing radial angiography.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Prevention of hand hematoma after radial angiography. Timepoint: The area of ​​the radial artery will be evaluated immediately after removing the cuffed transparent cuff, 2, 4, 6 hours after removing the transparent cuff and the morning after the angiography. Method of measurement: The Christensen scale is used as a scale to evaluate the efficiency of hemostasis methods by evaluating the incidence of hematoma at different hours after the procedure.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-11</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>No. 20 , Moallem Ave., Vincheh., Mobarakeh Mobarakeh Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
