<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03773614</url>
  </required_header>
  <id_info>
    <org_study_id>2017/1363</org_study_id>
    <nct_id>NCT03773614</nct_id>
  </id_info>
  <brief_title>Impairing Drugs and Alcohol as Risk Factors for Traumatic Injuries</brief_title>
  <acronym>IDART</acronym>
  <official_title>Impairing Drugs and Alcohol as Risk Factors for Traumatic Injuries - a National Study on Injury Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian National Trauma Registry</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian National Advisory Unit on Trauma</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian Public Roads Administration</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian Directorate of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian Ministry of Transport and Communications</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sykehuset Innlandet HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Impairing drugs and alcohol are major risk factors for traumatic injuries. Still there is to&#xD;
      date little knowledge to what extent these factors affect the epidemiology of trauma.&#xD;
      Detailed mapping of risk factors improve targeting and efficiency of primary injury&#xD;
      prevention. The aim of this project is therefore to facilitate injury prevention through&#xD;
      improved data collection and analysis on impairing drugs and alcohol as a contributing and&#xD;
      modifiable factor in injury morbidity and mortality.&#xD;
&#xD;
      Study question: What is the toxicological profile among patients with suspected severe&#xD;
      traumatic injury? Study design: a prospective population-based and national observational&#xD;
      study will analyse toxicology from blood samples of all trauma admission during a 12 month&#xD;
      study period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">February 29, 2020</completion_date>
  <primary_completion_date type="Actual">February 29, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Weeks</target_duration>
  <primary_outcome>
    <measure>Presence of alcohol in blood samples.</measure>
    <time_frame>Blood sample are collected at time of hospital admission for each participant. There is only one sample taken from each participant. Samples are consecutively analyzed during the study period. The database is analyzed after study period is completed.</time_frame>
    <description>Alcohol is reported in grams per liter. Analysis of alcohol is performed with an automated enzymatic method using alcohol dehydrogenase.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of impairing illicit and medicinal drugs in blood samples.</measure>
    <time_frame>Blood sample are collected at time of hospital admission for each participant. There is only one sample taken from each participant. Samples are consecutively analyzed during the study period.</time_frame>
    <description>Impairing substances are reported as nanogram per milliliter. Analysis is performed using liquid chromatography coupled with mass spectrometry.</description>
  </primary_outcome>
  <enrollment type="Actual">5000</enrollment>
  <condition>Trauma Injury</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All trauma patients received by trauma team at any Norwegian trauma hospital during the&#xD;
        study period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  admission to any Norwegian Trauma Hospital (n=37) AND trauma team activation, during&#xD;
             study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age&#xD;
&#xD;
          -  foreign citizens&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>OsloUH</name>
      <address>
        <city>Oslo</city>
        <zip>0372</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>June 18, 2021</last_update_submitted>
  <last_update_submitted_qc>June 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Thomas Kristiansen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03773614
org study id: 2017/1363
nct id: NCT03773614
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Impairing drugs and alcohol are major risk factors for traumatic injuries. Still there is to
      date little knowledge to what extent these factors affect the epidemiology of trauma.
      Detailed mapping of risk factors improve targeting and efficiency of primary injury
      prevention. The aim of this project is therefore to facilitate injury prevention through
      improved data collection and analysis on impairing drugs and alcohol as a contributing and
      modifiable factor in injury morbidity and mortality.

      Study question: What is the toxicological profile among patients with suspected severe
      traumatic injury? Study design: a prospective population-based and national observational
      study will analyse toxicology from blood samples of all trauma admission during a 12 month
      study period.
observational model: Case-Only
time perspective: Prospective
measure: Presence of alcohol in blood samples.
time frame: Blood sample are collected at time of hospital admission for each participant. There is only one sample taken from each participant. Samples are consecutively analyzed during the study period. The database is analyzed after study period is completed.
description: Alcohol is reported in grams per liter. Analysis of alcohol is performed with an automated enzymatic method using alcohol dehydrogenase.
measure: Presence of impairing illicit and medicinal drugs in blood samples.
time frame: Blood sample are collected at time of hospital admission for each participant. There is only one sample taken from each participant. Samples are consecutively analyzed during the study period.
description: Impairing substances are reported as nanogram per milliliter. Analysis is performed using liquid chromatography coupled with mass spectrometry.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Thomas Kristiansen
investigator title: Principal Investigator
mesh term: Wounds and Injuries