<?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>IRCT20190429043416N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-22</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of Erythropoietin's effect in patients consciousness</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Erythropoietin's effect in patients consciousness with severe Traumatic Brain Injury</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-02-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>18</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39141</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study Simple Randomization is used for random allocation of samples.For this purpose,referring to Web Site: www.graphpad/quickcalcs/, we use Random Allocation Software for randomization in two groups trial. Sample allocation order is as follows: 
B=1, A=2, B=3, B=4, A=5, B=6, B=7, A=8, A=9, A=10, B=11, A=12, B=13, B=14, A=15, B=16, A=17, A=18, Blinding description: This study is Double blinded. Patients, clinical nurses, researcher and physicians being kept blinded.</study_design>
      <phase>3</phase>
      <hc_freetext>Traumatic Brain Injury.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After 24 hours of brian injury 40000 unit of Erythropoietin Ampule via intravenous pathway is injected and patients receive 8000 unit of Erythropoietin intravenously daily until two weeks. Each Erythropoietin Ampule contains 4000 uint (0/5 mililiter) which is prepared from Pooyesh Daru Factory. Intervention 2: Control group:Patients receive 1 mililiter of Normal Saline daily intravenously as Placebo.</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 Our data will be published as a randomised clinical trial.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Atabak Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina Hospital., Hasan Abad Square., Emam Khomeini Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1136746911</zip>
        <telephone>+98 21 6634 8500</telephone>
        <email>nadjafia@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Atabak Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina Hospital., Hasan Abad Square., Emam Khomeini Ave</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1136746911</zip>
        <telephone>+98 21 6634 8500</telephone>
        <email>nadjafia@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Range of Age  between 15-65 years
Traumatic Brain Injury(Epidural, Subdural, Intracranial, Intraventricular, Subarachnoid Hemorrhage, Diffuse Axonal Injury)
Level of consciousness equal and less than 9
Hemoglobin less than 18
Mean Arterial Pressure less than 130
Onset of Brain Injury less than 24 hours
Lack of  History of Venous Thrombosis</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Oragn Dysfunction(Uremic and Hepatic Encephalopathy)
History of Malignancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S06.899</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified intracranial injury with loss of consciousness of unspecified duration</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After 24 hours of brian injury 40000 unit of Erythropoietin Ampule via intravenous pathway is injected and patients receive 8000 unit of Erythropoietin intravenously daily until two weeks. Each Erythropoietin Ampule contains 4000 uint (0/5 mililiter) which is prepared from Pooyesh Daru Factory.</i_keyword>
      <i_keyword>Control group:Patients receive 1 mililiter of Normal Saline daily intravenously as Placebo.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of Consciousness. Timepoint: Evaluation of level of consciousness in initial of the study(before intervention) and daily until two weeks after Erythropoietin injection. Method of measurement: Glascow Coma Score, Four Score.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Time course for complete wakefullness after first Erythropoietin or Placebo injection. Timepoint: Daily until two weeks after Erythropoietin or Placebo injection. Method of measurement: Nursing Questionary.</sec_outcome>
      <sec_outcome>Time course after Brain Injury until first Erythropoietin or Placebo injection. Timepoint: Onset of the study (before injection). Method of measurement: Nursing Questionary.</sec_outcome>
      <sec_outcome>Time course for increasing in Glascow Coma Score and Four Score after first Erythropoietin  or Placebo injection. Timepoint: Daily until two weeks after Erythropoietin or Placebo injection. Method of measurement: Nursing Questionary.</sec_outcome>
      <sec_outcome>Incidense of Deep Vein Thrombosis. Timepoint: Daily from first Erythropoietin injection until last injection. Method of measurement: Physical Exam, Doppler Ultra Sonography of lower Extremity.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-02-12</approval_date>
        <contact_name>Ethics committee of Biomedical Research of Tehran University of Medical Science</contact_name>
        <contact_address>First floor, Building No 1 of school of Medicine, North Door of Poorsina Ave., Qods Ave., Enghelab Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
