<?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>IRCT201210223773N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-03-10</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences, Medical Faculty</primary_sponsor>
      <public_title>comparison of crystalloid and colloid solutions effect on clot formation time and clot firmness after 10 minutes during the upper or lower limbs surgeries</public_title>
      <acronym></acronym>
      <scientific_title>comparison of crystalloid and colloid solutions effect on clot formation time and clot firmness after 10 minutes during the upper or lower limbs surgeries</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-11-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3881</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: clot firmness after 10 minutes. Condition 2: clot formation time.</hc_freetext>
      <i_freetext>Intervention 1: The first group will receive only crystalloid solutions. &#13;
Solutions will be prescribed to the 55 ml / kg. Once before and one hour after administration of the solution, blood samples will be taken from three groups of patients. Using Fibtem inhibitor solution, clot formation time and clot firmness after 10 minutes are measured by Thromboelastometer.Statistical analysis of patient records, prescribing of these solutions will be compared. Intervention 2: Solutions will be prescribed to the 55 ml / kg. Once before and one hour after administration of the solution, blood samples will be taken from three groups of patients. Using Fibtem inhibitor solution, clot formation time and clot firmness after 10 minutes are measured by Thromboelastometer.Statistical analysis of patient records, prescribing of these solutions will be compared.&#13;
 Second group will receive modified gelatin. Intervention 3: third group will receive  hydroxyethyl Starch6%. Solutions will be prescribed to the 55 ml / kg. Once before and one hour after administration of the solution, blood samples will be taken from three groups of patients. Using Fibtem inhibitor solution, clot formation time and clot firmness after 10 minutes are measured by Thromboelastometer.Statistical analysis of patient records, prescribing of these solutions will be compared.</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>Farsad Imani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina Hospital, Hasan'abad Sq., Imam Khomeini St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 63120</telephone>
        <email>imanifar@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Farsad Imani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sina Hospital, Hasan'abad Sq., Imam Khomeini St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1136746911</zip>
        <telephone>+98 21 63120</telephone>
        <email>imanifar@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria; patients weighing more than 40 kg; Patients undergoing upper or lower limbs surgeries under general anesthesia or regional. Exclusion criteria:&#13;
Patients received solutions other than standard maintenance solutions prior to the induction of anesthesia; Nonsteroidal anti-inflammatory drug use; taking any anticoagulant medications; Patients who have more than 100 cc of blood loss during the test period.</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D69.9</hc_code>
      <hc_code>D65</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Haemorrhagic condition, unspecified</hc_keyword>
      <hc_keyword>Consumption coagulopathy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first group will receive only crystalloid solutions. &#13;
Solutions will be prescribed to the 55 ml / kg. Once before and one hour after administration of the solution, blood samples will be taken from three groups of patients. Using Fibtem inhibitor solution, clot formation time and clot firmness after 10 minutes are measured by Thromboelastometer.Statistical analysis of patient records, prescribing of these solutions will be compared.</i_keyword>
      <i_keyword>Solutions will be prescribed to the 55 ml / kg. Once before and one hour after administration of the solution, blood samples will be taken from three groups of patients. Using Fibtem inhibitor solution, clot formation time and clot firmness after 10 minutes are measured by Thromboelastometer.Statistical analysis of patient records, prescribing of these solutions will be compared.&#13;
 Second group will receive modified gelatin</i_keyword>
      <i_keyword>third group will receive  hydroxyethyl Starch6%. Solutions will be prescribed to the 55 ml / kg. Once before and one hour after administration of the solution, blood samples will be taken from three groups of patients. Using Fibtem inhibitor solution, clot formation time and clot firmness after 10 minutes are measured by Thromboelastometer.Statistical analysis of patient records, prescribing of these solutions will be compared.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clot firmness after 10 minutes. Timepoint: Before and one hour after administration of solutions. Method of measurement: by Thromboelastometer.</prim_outcome>
      <prim_outcome>Clot formation time. Timepoint: Before and one hour after administration of solutions. Method of measurement: by Thromboelastometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effects. Timepoint: during and after surgery. Method of measurement: Physical examination.</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, Medical Faculty</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2012-09-16</approval_date>
        <contact_name>Tehran University of Medical Sciences-Research administration</contact_name>
        <contact_address>Keshavarz Bv. Ghods st. Cross Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
