<?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>IRCT20151112025009N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-04</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of rewarming on injury outcome, injury severity and arterial blood gases of trauma patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of rewarming on injury outcome, injury severity and arterial blood gases of trauma patients hospitalized in emergency department</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28398</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: This study was a clinical trial with control group. The reheat approach is carried out by the researcher responsible for the study at the time until the sample size is completed. The study population consisted of all trauma patients admitted to emergency department of Ayatollah Mousavi Hospital in Zanjan.
After determining the sample size, this study was performed using Poisson's model (so that according to the sample size the duration of intervention was determined) and by random sampling (block) randomized block with two groups of control and test in Blocks 6 The number of blocks from the random number table, the entry and arrangement of patients to each of the groups will be based on the criteria for entering the number of blocks, respectively. The usual care group will receive the trauma and reheat test group as intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypothermia.</hc_freetext>
      <i_freetext>Intervention group: they will receive rewarming strategies (wear wet clothes, avoid getting cold, warm, and adjusting the ambient temperature, using a suitable blanket of linen linen with a waterproof layer, a disposable cap with a foil layer, injections of warm veins with a blood heater and liquids )according to the entry criteria..</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data on the primary and secondary consequences can be shared.

When:
Start of access from the second half of 1397

To whom:
For researchers working in academic and scientific institutions

Conditions:
It can be used in coordination with the scientific authority

Where to obtain:
mdinmohammadi@zums.ac.ir

How to obtain:
Contact by email with the scientific project manager

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Sadeghi Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan - Azadi Square - Beginning of the Islamic Republic Boulevard - Central Station of Zanjan University of Medical Sciences</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515613191</zip>
        <telephone>+98 24 3342 4771</telephone>
        <email>sara.sadeghimohammad@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadreza Dinmohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan - Azadi Square - Beginning of the Islamic Republic Boulevard - Central Station of Zanjan University of Medical Sciences</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4515613191</zip>
        <telephone>+98 24 3342 4771</telephone>
        <email>mdinmohammadi@zums.ac.ir</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with traumatic ranges aged 18-65 years old with a core temperature of less than 38 ° C and above 28 ° C
Without loss of consciousness
Transfer time to the center of less than one hour
ISS score above 9 And less than 40</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Progression to severe hypothermia (core body temperature below 28 ° C)
Exits from the emergency less than 6 hours
Death less than 24 hours after admission
Decreased GCS awareness less than 13
At each stage of the intervention, cardiopulmonary arrest before reaching the center or at any stage of intervention and dissatisfaction of the patient or his family</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T68</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypothermia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: they will receive rewarming strategies (wear wet clothes, avoid getting cold, warm, and adjusting the ambient temperature, using a suitable blanket of linen linen with a waterproof layer, a disposable cap with a foil layer, injections of warm veins with a blood heater and liquids )according to the entry criteria.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determination and comparison of death rate, admission rate, hospitalization period, injury severity and arterial blood gas levels in hospitalized patients in the emergency department of Ayatollah Mousavi Hospital in Zanjan in the control and test groups. Timepoint: Measurement of central temperature at the first hour (every 15 minutes) and 6 hours to reach normal temperature - Arterial blood gases taken at one hour and six hours after hospitalization - Measuring the deterioration of the injury with the standard ISS, RTS- Track the patients' situation after ten days of the incident. Method of measurement: Tympanic thermometer digital  - Machines ABG optimedical - measure the severity of the injury criteria (Injury Severity Score Revised Trauma Score).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Injury outcome (length of stay in hospitals, admission to the intensive care unit, death). Timepoint: Deaths up to 10 days. Method of measurement: Medical documents.</sec_outcome>
      <sec_outcome>Injury Severity. Timepoint: Admission, at the first hour, six hours later, if admitted to the special department. Method of measurement: Revised Trauma Score.</sec_outcome>
      <sec_outcome>Arterial blood gas. Timepoint: Before intervention 6 and 12 hours later intervention. Method of measurement: Radial artery blood sampling.</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-03</approval_date>
        <contact_name>Ethics committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Azadi Square - Beginning of the Islamic Republic Boulevard - Central Station of Zanjan University of Medical Sciences Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
