<?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>IRCT2013050713261N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-08-03</date_registration>
      <primary_sponsor>Personal</primary_sponsor>
      <public_title>Gi bleeding treathment</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of injective pantoprazole and  oral Rabeprazol in patients with upper gastrointestinal bleeding</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>114</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13176</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Upper gibleeding.</hc_freetext>
      <i_freetext>Intervention 1: Initial treatment included water and electrolyte balancing and injection of Pantoprazole 80 mg and 8 mg per hour and in 24 hours endoscopy was performed on the patients and in patients who had active bleeding or their veins could be seen or had affixed clots based on Rockall, Forrest and Blatch Ford measures epinephrine was injected and if the bleeding was controlled another injection of Pantoprazole was performed in 6 hours and if the clinical signs were stable liquid was started and the patients were randomly (according to random number generator table) divided into two groups a group that continued injection of Pantoprazole 8 mg per hour . Also the drug side effects were determined in the patients.for all patient endoscopy done in 2 th days. Intervention 2: The second group that consumes edible Rabeprazole 40 mg each 12 hours. For all patient endoscopy done in 2 th days.</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>Mohammad Amir Sarabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebne Sina ave. , Shahid Ghandi blvd. ,</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916886938</zip>
        <telephone>+98 35 1822 4201</telephone>
        <email>masarabi@ssu.ac.irdrsam_amir@yahoo.com</email>
        <affiliation>personal</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Amir Sarabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebne Sina ave. , Shahid Ghandi blvd. ,</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916886938</zip>
        <telephone>+98 35 1822 4201</telephone>
        <email>masarabi@ssu.ac.irdrsam_amir@yahoo.com</email>
        <affiliation>personal</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The patients with upper gastrointestinal bleeding and treated by epinephrine injection who wanted to participate in the study and do not had allergy to the &#13;
  Inclusion criteria: underwent urgent endoscopy within 24 h after&#13;
presentation,  had peptic ulcers in the distal oesophagus, stomach or duodenum,  had high-risk stigmata including active bleeding , nonbleeding visible vessels , or adherent clots , and  successful haemostasis was achieved with endoscopic injection of epinephrine. Written informed consent was obtained before enrolment.&#13;
Exclusion criteria:&#13;
pregnant; did not obtain initial haemostasis with endoscopic&#13;
injection of epinephrine; did not give written&#13;
informed consent; had bleeding tendency (platelet count&#13;
&lt;50000 , PT &gt; 3 s of normal, CT and BT prolong or were&#13;
taking anticoagulants); had uraemia ; bleeding gastric cancer.</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K92.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gastrointestinal haemorrhage, 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>Initial treatment included water and electrolyte balancing and injection of Pantoprazole 80 mg and 8 mg per hour and in 24 hours endoscopy was performed on the patients and in patients who had active bleeding or their veins could be seen or had affixed clots based on Rockall, Forrest and Blatch Ford measures epinephrine was injected and if the bleeding was controlled another injection of Pantoprazole was performed in 6 hours and if the clinical signs were stable liquid was started and the patients were randomly (according to random number generator table) divided into two groups a group that continued injection of Pantoprazole 8 mg per hour . Also the drug side effects were determined in the patients.for all patient endoscopy done in 2 th days.</i_keyword>
      <i_keyword>The second group that consumes edible Rabeprazole 40 mg each 12 hours. For all patient endoscopy done in 2 th days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>No reebleeding. Timepoint: 72h. Method of measurement: patient Symptoms and endoscopy in second 24 h.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hospital stay and mortality and blood transfusion. Timepoint: 72h. Method of measurement: symptoms.</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>Personal</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-03-06</approval_date>
        <contact_name>Shahid Sadoughi  University of Medical Sciences</contact_name>
        <contact_address>Ebne Sina ave. , , Atlasi sq. , Yazd, Iran Yazd  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
