<?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>IRCT20200929048885N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-19</date_registration>
      <primary_sponsor>Shaheed Rajaie Cardiovascular, Medical &amp; Research Center</primary_sponsor>
      <public_title>The Effect of Heparin Concentration of 1000 units per ml in Blood Samples on the Results of Venous Blood Gases intensive care unit patients</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Heparin Concentration of 1000 units per ml in Blood Samples on the Results of Venous Blood Gases intensive care unit patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>141</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/51306</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: First, all participants will be explained how to implement the project. The syringes will then be placed in two groups of heparin 1000 units (heparinized syringes with 1000 units) and heparin 5000 units (the common method of heparinized syringes with heparin is 5000 units). An equal number of insulin syringes will be heparinized by the researcher in one group (A) with 1000 units of heparin solution (0.05 cc) and the other group (B) with 5000 units of heparin with the same amount (0.05 cc). They will be divided equally by the researcher (0.5 cc or 50 units per syringe) into two insulin syringes heparinized with codes A (heparin 1000 units) and B (heparin 5000 units) that only the researcher knew about. It is then placed on ice and sent to the laboratory within 10 minutes, along with a test sheet that lists the necessary parameters (patient biography, body temperature, hemoglobin level, oxygen intake). A laboratory that does not know the amount of heparin in the syringes is given to the analyzer.</study_design>
      <phase>N/A</phase>
      <hc_freetext>heparin soduim.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Dilute an equal number of insulin syringes in a group (intervention group) with 1000 units of heparin solution (to prepare 1000 units of heparin, dilute one ampoule of 5000 units of heparin with 4 cc of distilled water in a 5 cc syringe and its volume To 5 cc, each cc equal to 1000 units), heparinized to 0.1 cc. Intervention 2: Control group: In the control group, based on the current situation, an ampoule of 5000 units of 0.1 ml of heparin was used to impregnate the insulin syringes used for blood sampling to test venous blood gases.</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 I need to consult with other members of the research team to publish it</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>rasool lakziyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>noor ST</address>
        <city>neyshabour</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1995614331</zip>
        <telephone>+98 51 4262 3781</telephone>
        <email>ccu1taha1992@gmail.com</email>
        <affiliation>Shaheed Rajaie Cardiovascular, Medical &amp; Research Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>rasool lakziyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>noor ST</address>
        <city>neyshabour</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1995614331</zip>
        <telephone>+98 51 4262 3781</telephone>
        <email>ccu1taha1992@gmail.com</email>
        <affiliation>Shaheed Rajaie Cardiovascular, Medical &amp; Research Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Satisfaction to participate in the study
Patients admitted to the cardiac intensive care unit
Age 60-18 years
Hemoglobin level more than 10 mg per deciliter</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>There coagulopathy or anticoagulant treatment of moderate to high dose
Death or discharge from the ward</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T45.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Primarily systemic and haematological agent, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Dilute an equal number of insulin syringes in a group (intervention group) with 1000 units of heparin solution (to prepare 1000 units of heparin, dilute one ampoule of 5000 units of heparin with 4 cc of distilled water in a 5 cc syringe and its volume To 5 cc, each cc equal to 1000 units), heparinized to 0.1 cc.</i_keyword>
      <i_keyword>Control group: In the control group, based on the current situation, an ampoule of 5000 units of 0.1 ml of heparin was used to impregnate the insulin syringes used for blood sampling to test venous blood gases.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pvo2. Timepoint: Immediately after venous blood sampling. Method of measurement: Laboratory, venous blood gas meter.</prim_outcome>
      <prim_outcome>Pvco2. Timepoint: Immediately after venous blood sampling. Method of measurement: Laboratory, venous blood gas meter.</prim_outcome>
      <prim_outcome>Hco3. Timepoint: Immediately after venous blood sampling. Method of measurement: Laboratory, venous blood gas meter.</prim_outcome>
      <prim_outcome>Buffer Base. Timepoint: Immediately after venous blood sampling. Method of measurement: Laboratory, venous blood gas meter.</prim_outcome>
      <prim_outcome>Base Exese. Timepoint: Immediately after venous blood sampling. Method of measurement: Laboratory, venous blood gas meter.</prim_outcome>
      <prim_outcome>PH. Timepoint: Immediately after venous blood sampling. Method of measurement: Laboratory, venous blood gas meter.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sodium. Timepoint: Immediately after venous blood sampling. Method of measurement: Laboratory, venous blood gas meter.</sec_outcome>
      <sec_outcome>Kalium. Timepoint: Immediately after venous blood sampling. Method of measurement: Laboratory, venous blood gas meter.</sec_outcome>
      <sec_outcome>Calcium. Timepoint: Immediately after venous blood sampling. Method of measurement: Laboratory, venous blood gas meter.</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>Shaheed Rajaie Cardiovascular, Medical &amp; Research Center</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-16</approval_date>
        <contact_name>Shaheed Rajaie Cardiovascular Medical and Research Center</contact_name>
        <contact_address>Tehran - Vali Asr St. (AS) - next to Mellat Park - corner of Niayesh Educational, Research and Treatment Center tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
