<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/NCT02996851</url>
  </required_header>
  <id_info>
    <org_study_id>2014/958</org_study_id>
    <nct_id>NCT02996851</nct_id>
  </id_info>
  <brief_title>Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs</brief_title>
  <official_title>Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs: a Nationwide Pharmacoepidemiological Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Olavs Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Oral antithrombotic medications (OAM) are used for the prevention and treatment of thrombotic&#xD;
      disorders. Among hemorrhagic complications of OAMs, intracranial hemorrhage (ICH) may have&#xD;
      particularly devastating consequences with high morbidity, disability and mortality rates.&#xD;
      The efficacy and safety profiles of OAMs are generally assessed in randomized controlled&#xD;
      trials (RCT), but included patients are often highly selected and may not be representative&#xD;
      of users in everyday clinical practice in terms of follow-up routines, age, gender, drug&#xD;
      compliance, and polypharmacy. Moreover, it is often unclear whether or not traumatic ICHs are&#xD;
      registered and reported in RCTs. Drifts in indications and treatment criteria may also be&#xD;
      seen in everyday practice and drug discontinuation due to precautionary concerns including&#xD;
      compliance, fall risk and comorbidity may be forgotten. Collectively, these factors may lead&#xD;
      to other and potentially higher traumatic ICH rates in general clinical use than reported in&#xD;
      RCTs.&#xD;
&#xD;
      The incidence rates of traumatic ICH in patients on OAMs in the general population remain&#xD;
      unknown. In this nationwide registry based pharmacoepidemiological study we will investigate&#xD;
      the incidence and case fatality of traumatic ICH in users of OAMs in Norway from 2008 through&#xD;
      2014.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2007</start_date>
  <completion_date type="Actual">December 31, 2014</completion_date>
  <primary_completion_date type="Actual">December 31, 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of intracranial hemorrhage requiring hospital admission</measure>
    <time_frame>at least 12 months following intracranial hemorrhage</time_frame>
    <description>Age- and gender-adjusted comparisons of annual incidence rates will be carried out</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of fatal traumatic intercranial hemorrhage defined as death within 90 days of admission</measure>
    <time_frame>90 days</time_frame>
    <description>Age- and gender-adjusted comparisons of annual incidence rates will be carried out.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival following traumatic intracranial hemorrhage</measure>
    <time_frame>6 years</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">6279</enrollment>
  <condition>Intracranial Hemorrhage, Traumatic</condition>
  <condition>Embolism and Thrombosis</condition>
  <condition>Hematoma, Subdural, Intracranial</condition>
  <eligibility>
    <study_pop>
      <textblock>
        (1) the Norwegian patient registry (NPR), which contains information about all admissions&#xD;
        to Norwegian hospitals since 2008 with diagnoses coded according to the 10th revision of&#xD;
        the International Classification of Diseases and (2) The Norwegian prescription database&#xD;
        (NorPD), which contains information about all prescriptions dispensed in Norway since 2004&#xD;
        including type of drug according to the Anatomical Therapeutic Chemical (ATC)&#xD;
        classification system, number of Defined Daily Doses (DDD) as defined by the World Health&#xD;
        Organization, date of dispensing, quantity dispensed, and drug strength and formulation.&#xD;
        The National Registry provides information to NPR and NorPD on vital status (dead or&#xD;
        alive).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  included in the Norwegian patient registry (NPR) and/or the Norwegian prescription&#xD;
             database (NorPD)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sasha Gulati, md phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>October 16, 2017</last_update_submitted>
  <last_update_submitted_qc>October 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fibrinolytic Agents</keyword>
  <keyword>Adverse effects</keyword>
  <keyword>Norway</keyword>
  <keyword>Registries</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Hemorrhages</mesh_term>
    <mesh_term>Intracranial Hemorrhage, Traumatic</mesh_term>
    <mesh_term>Hematoma, Subdural</mesh_term>
    <mesh_term>Hematoma, Subdural, Intracranial</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Embolism</mesh_term>
    <mesh_term>Embolism and Thrombosis</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Hematoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02996851
org study id: 2014/958
nct id: NCT02996851
lead sponsor: 
collaborator: 
has dmc: No
Oral antithrombotic medications (OAM) are used for the prevention and treatment of thrombotic
      disorders. Among hemorrhagic complications of OAMs, intracranial hemorrhage (ICH) may have
      particularly devastating consequences with high morbidity, disability and mortality rates.
      The efficacy and safety profiles of OAMs are generally assessed in randomized controlled
      trials (RCT), but included patients are often highly selected and may not be representative
      of users in everyday clinical practice in terms of follow-up routines, age, gender, drug
      compliance, and polypharmacy. Moreover, it is often unclear whether or not traumatic ICHs are
      registered and reported in RCTs. Drifts in indications and treatment criteria may also be
      seen in everyday practice and drug discontinuation due to precautionary concerns including
      compliance, fall risk and comorbidity may be forgotten. Collectively, these factors may lead
      to other and potentially higher traumatic ICH rates in general clinical use than reported in
      RCTs.

      The incidence rates of traumatic ICH in patients on OAMs in the general population remain
      unknown. In this nationwide registry based pharmacoepidemiological study we will investigate
      the incidence and case fatality of traumatic ICH in users of OAMs in Norway from 2008 through
      2014.
observational model: Ecologic or Community
time perspective: Retrospective
measure: incidence of intracranial hemorrhage requiring hospital admission
time frame: at least 12 months following intracranial hemorrhage
description: Age- and gender-adjusted comparisons of annual incidence rates will be carried out
measure: incidence of fatal traumatic intercranial hemorrhage defined as death within 90 days of admission
time frame: 90 days
description: Age- and gender-adjusted comparisons of annual incidence rates will be carried out.
measure: overall survival following traumatic intracranial hemorrhage
time frame: 6 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sasha Gulati, md phd
role: Principal Investigator
affiliation: Norwegian University of Science and Technology
responsible party type: Sponsor
mesh term: Intracranial Hemorrhages
mesh term: Intracranial Hemorrhage, Traumatic
mesh term: Hematoma, Subdural
mesh term: Hematoma, Subdural, Intracranial
mesh term: Thrombosis
mesh term: Embolism
mesh term: Embolism and Thrombosis
mesh term: Hemorrhage
mesh term: Hematoma
sharing ipd: No