<?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>IRCT20200208046414N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-04</date_registration>
      <primary_sponsor>Ghoum University of Medical Sciences</primary_sponsor>
      <public_title>"Effect of propofol in severe intracerebral hemorrhage "</public_title>
      <acronym>ICH( intracerebral hemorrhage)</acronym>
      <scientific_title>Comparison of the efficacy of  intravenous propofol infusion with conservative treatment in outcome of patients with severe intracerebral hemorrhage hospital based</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/45658</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: At all stages of the study, the researchers responsible for evaluating the outcome of the patients would be blind to the grouping performed.</study_design>
      <phase>3</phase>
      <hc_freetext>Nontraumatic intracranial hemorrhage.</hc_freetext>
      <i_freetext>Intervention 1: In addition to routine treatment and care, a 25-75 µg / kg / min intravenous infusion will be used within the first 24 hours. NIHSS, GCS and bleeding volume will be recorded on arrival and daily for up to 7 days. Also, mortality rate, duration of hospitalization, extent of hemorrhage and mRS, NIHSS, GCS in the group receiving propofol will be compared using appropriate statistical tests. Cardiac wall, measurement of oxygen saturation of peripheral blood by pulse oxy meters, standard neurological treatments and standard rehabilitation measures will be performed. Intervention 2: Control group: In patients of the intervention group routine supportive measures in patients with intracerebral hemorrhage hospitalized in the intensive care unit such as blood pressure measurement, ECG monitoring, measurement of peripheral blood oxygen saturation by pulse oximeter, standard neurological treatments and Standard rehabilitation procedures will be performed. All demographic and clinical information of patients will be recorded in questionnaires designed by researchers and the amount of mRS, NIHSS, GCS and bleeding volume will be recorded at the beginning of the day and up to 7 days. Also, mortality rate, duration of hospitalization, extent of hemorrhage expansion and rate of mRS, NIHSS, GCS in the control group will be compared using appropriate statistical tests. Standard neurological treatments and standard rehabilitation measures will be performed.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Ehsan Sharifipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine. Pardis Complex. in front of Yadegar Imam Stadium.Ghadir Boulevard</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3736175513</zip>
        <telephone>+98 25 3320 9071</telephone>
        <email>sharifipour.e@muq.ir</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Ehsan Sharifipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine. Pardis Complex. in front of Yadegar Imam Stadium.Ghadir Boulevard</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3736175513</zip>
        <telephone>+98 25 3320 9071</telephone>
        <email>sharifipour.e@muq.ir</email>
        <affiliation>Ghoum University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Acute ICH over 15 years of ages
No surgery indication by the neurosurgery team
NIHSS above 15</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy &amp;lactation
Concurrent Malignancy
CKD or chronic hepatic failure or another chronic sickness
History of drug sensitivity used in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I62.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nontraumatic intracranial hemorrhage, 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>In addition to routine treatment and care, a 25-75 µg / kg / min intravenous infusion will be used within the first 24 hours. NIHSS, GCS and bleeding volume will be recorded on arrival and daily for up to 7 days. Also, mortality rate, duration of hospitalization, extent of hemorrhage and mRS, NIHSS, GCS in the group receiving propofol will be compared using appropriate statistical tests. Cardiac wall, measurement of oxygen saturation of peripheral blood by pulse oxy meters, standard neurological treatments and standard rehabilitation measures will be performed.</i_keyword>
      <i_keyword>Control group: In patients of the intervention group routine supportive measures in patients with intracerebral hemorrhage hospitalized in the intensive care unit such as blood pressure measurement, ECG monitoring, measurement of peripheral blood oxygen saturation by pulse oximeter, standard neurological treatments and Standard rehabilitation procedures will be performed. All demographic and clinical information of patients will be recorded in questionnaires designed by researchers and the amount of mRS, NIHSS, GCS and bleeding volume will be recorded at the beginning of the day and up to 7 days. Also, mortality rate, duration of hospitalization, extent of hemorrhage expansion and rate of mRS, NIHSS, GCS in the control group will be compared using appropriate statistical tests. Standard neurological treatments and standard rehabilitation measures will be performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>NIHSS. Timepoint: onset of study . 7th day .90th day. Method of measurement: table of NIHSS.</prim_outcome>
      <prim_outcome>MRS. Timepoint: Onset of study . 7th and 90th day. Method of measurement: Table of MRS.</prim_outcome>
      <prim_outcome>Brain Edema. Timepoint: 3th &amp; 7th day. Method of measurement: Brain CT scan.</prim_outcome>
      <prim_outcome>Expansion of Hemorage. Timepoint: 3th &amp;7th day. Method of measurement: Brain CT scan.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Time of Hospitalization. Timepoint: End of hospitalization. Method of measurement: day.</sec_outcome>
      <sec_outcome>Mortality rate. Timepoint: mortality. Method of measurement: yes /no.</sec_outcome>
      <sec_outcome>Time of intubation. Timepoint: End of Intubation. Method of measurement: day.</sec_outcome>
      <sec_outcome>Complication. Timepoint: End of study. Method of measurement: Brain CT.</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>Ghoum University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-12</approval_date>
        <contact_name>Ethics committee of Qom University of Medical Sciences</contact_name>
        <contact_address>No.83, 4th Ave., Jahad Daneshgahi Ave., Safa Shahr Blvd. Qom Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
