<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/NCT02244983</url>
  </required_header>
  <id_info>
    <org_study_id>FUKNO_Protokoll_17-07-14</org_study_id>
    <nct_id>NCT02244983</nct_id>
  </id_info>
  <brief_title>Falls Of Unknown Origin (FUKNO) - Are Morbidity and Mortality Predictable in Patients Presenting With Falls?</brief_title>
  <acronym>FUKNO</acronym>
  <official_title>Falls Of Unknown Origin (FUKNO) - Are Morbidity and Mortality Predictable in Patients Presenting With Falls?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is the investigators goal to identify the prevalence of underlying diseases, make&#xD;
      disposition more rational, and establish risk stratification tools in elderly patients&#xD;
      presenting with falls. Additionally, the outcome of standard care (clinical assessment only&#xD;
      for disposition) will be compared with a new approach combining the standard of care with&#xD;
      biomarker assisted disposition of elderly patients presenting with falls. Therefore the&#xD;
      investigators are looking at the following points.&#xD;
&#xD;
      Emergency department work-up&#xD;
&#xD;
        1. Prevalence of underlying disease&#xD;
&#xD;
        2. Developing algorithms for initial assessment Disposition&#xD;
&#xD;
      a. Establishing biomarker enhanced disposition planning by using risk-stratification tools b.&#xD;
      Comparing geriatric emergency assessment to standardized disposition planning&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 12, 2014</start_date>
  <completion_date type="Actual">December 2, 2021</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>30 Days</target_duration>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 Days</time_frame>
    <description>Data Collection via Case Report Form</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute Morbidity</measure>
    <time_frame>30 Days</time_frame>
    <description>Data Collection via Case Report Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Institutionalisation</measure>
    <time_frame>180 Days</time_frame>
    <description>Data Collection via interview with general practitioner</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disposition</measure>
    <time_frame>30 Days</time_frame>
    <description>Data collection via case report form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>90 Days</time_frame>
    <description>Data Collection via Case Report Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>180 Days</time_frame>
    <description>Data Collection via Case Report Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>365 Days</time_frame>
    <description>Data Collection via Case Report Form</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">587</enrollment>
  <condition>Accidental Falls</condition>
  <condition>Underlying Disease of Falls</condition>
  <arm_group>
    <arm_group_label>EFAB 65</arm_group_label>
    <description>Patients presenting to the emergency department with falls, above 65 years of age. Patients History will be taken as well as a blood sample</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patients History</intervention_name>
    <description>History taking and drawing of a blood sample</description>
    <arm_group_label>EFAB 65</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All fall patients aged 65 years and older who presented to the emergency department giving&#xD;
        written informed consentent&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All fall patients aged 65 years and older who presented to the emergency department&#xD;
             giving written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients below 65 years&#xD;
&#xD;
          -  Non-fall patients above 65 years&#xD;
&#xD;
          -  or lack of informed consent by patients or proxies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roland Bingisser, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Basel, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charité Campus Benjamin Franklin, Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <state>Basel Stadt</state>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cantonal Hospital Baselland, Bruderholz</name>
      <address>
        <city>Basel</city>
        <zip>4101</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cantonal Hospital Baselland, Liestal</name>
      <address>
        <city>Liestal</city>
        <zip>4410</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02244983
org study id: FUKNO_Protokoll_17-07-14
nct id: NCT02244983
lead sponsor: 
has dmc: Yes
It is the investigators goal to identify the prevalence of underlying diseases, make
      disposition more rational, and establish risk stratification tools in elderly patients
      presenting with falls. Additionally, the outcome of standard care (clinical assessment only
      for disposition) will be compared with a new approach combining the standard of care with
      biomarker assisted disposition of elderly patients presenting with falls. Therefore the
      investigators are looking at the following points.

      Emergency department work-up

        1. Prevalence of underlying disease

        2. Developing algorithms for initial assessment Disposition

      a. Establishing biomarker enhanced disposition planning by using risk-stratification tools b.
      Comparing geriatric emergency assessment to standardized disposition planning
observational model: Cohort
time perspective: Prospective
measure: Mortality
time frame: 30 Days
description: Data Collection via Case Report Form
measure: Acute Morbidity
time frame: 30 Days
description: Data Collection via Case Report Form
measure: Institutionalisation
time frame: 180 Days
description: Data Collection via interview with general practitioner
measure: Disposition
time frame: 30 Days
description: Data collection via case report form
measure: Mortality
time frame: 90 Days
description: Data Collection via Case Report Form
measure: Mortality
time frame: 180 Days
description: Data Collection via Case Report Form
measure: Mortality
time frame: 365 Days
description: Data Collection via Case Report Form
arm group label: EFAB 65
description: Patients presenting to the emergency department with falls, above 65 years of age. Patients History will be taken as well as a blood sample
intervention type: Other
intervention name: Patients History
description: History taking and drawing of a blood sample
arm group label: EFAB 65
Blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Roland Bingisser, MD
role: Principal Investigator
affiliation: University Hospital, Basel, Switzerland
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Switzerland
responsible party type: Sponsor