<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/NCT04439383</url>
  </required_header>
  <id_info>
    <org_study_id>RISE</org_study_id>
    <nct_id>NCT04439383</nct_id>
  </id_info>
  <brief_title>Risk Stratification for Venous Thromboembolism in Hospitalized Medical Patients</brief_title>
  <acronym>RISE</acronym>
  <official_title>Risk Stratification for Hospital-Acquired Venous Thromboembolism in Medical Patients: a Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier Universitaire Vaudois</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</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>
      Hospital-acquired venous thromboembolism (HA-VTE) is one of the leading preventable causes of&#xD;
      in-hospital mortality, but prevention of VTE in hospitalized medical patients remains&#xD;
      challenging, as preventive measures such as pharmacological thromboprophylaxis (TPX) need to&#xD;
      be tailored to individual thrombotic risk.&#xD;
&#xD;
      The broad objective of this project is to improve VTE prevention strategies in hospitalized&#xD;
      medical patients by prospectively examining VTE risk factors (including mobility) and&#xD;
      comparing existing risk assessment models.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Actual">April 1, 2022</completion_date>
  <primary_completion_date type="Actual">April 1, 2022</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Venous thromboembolism</measure>
    <time_frame>Within 90 days of initial hospital admission</time_frame>
    <description>Symptomatic, objectively confirmed fatal and non-fatal hospital-acquired venous thromboembolism, including symptomatic distal and proximal deep vein thrombosis and pulmonary embolism after hospital admission</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Venous thromboembolism</measure>
    <time_frame>During the initial hospitalization, an average of 7 days</time_frame>
    <description>Symptomatic, objectively confirmed fatal and non-fatal hospital-acquired venous thromboembolism, including symptomatic distal and proximal deep vein thrombosis and pulmonary embolism during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission</time_frame>
    <description>All-cause mortality (all causes of death will be considered)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major bleeding</measure>
    <time_frame>During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission</time_frame>
    <description>Major bleeding will be defined as fatal bleeding, symptomatic bleeding at critical sites (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, or intramuscular with compartment syndrome), or bleeding with a reduction of hemoglobin of at least 20 g/L or bleeding leading to transfusion of 2 or more units of packed red blood cells according to the definition of the International Society on Thrombosis and Haemostasis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically relevant non-major bleeding</measure>
    <time_frame>During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission</time_frame>
    <description>Clinically relevant non-major bleeding, defined as overt bleeding that does not meet criteria for major bleeding but is associated with a medical intervention, unscheduled physician contact (visit or telephone call), or pain or impairment of activities of daily life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient autonomy in the activities of daily living</measure>
    <time_frame>At discharge (an average of 7 days after initial hospital admission) and at 90 days after admission</time_frame>
    <description>Patient autonomy in the activities of daily living as assessed by the modified Barthel Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>within 90 days of initial hospital admission</time_frame>
    <description>Length of hospital stay, defined as the time/date of discharge minus time/date of admission at the hospital ward</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subsequent hospitalizations</measure>
    <time_frame>Within 90 days of initial hospital admission</time_frame>
    <description>Subsequent hospitalization, defined as hospital readmissions</description>
  </secondary_outcome>
  <enrollment type="Actual">1353</enrollment>
  <condition>Venous Thromboembolism</condition>
  <condition>Venous Thromboses</condition>
  <condition>Pulmonary Embolism</condition>
  <condition>Deep Vein Thrombosis</condition>
  <condition>Embolism and Thrombosis</condition>
  <condition>Mobility Limitation</condition>
  <condition>Hospital Acquired Condition</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Acutely ill adult patients hospitalized for at least 24h in general internal medicine of&#xD;
        the participating tertiary care hospitals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Admitted for hospitalization &gt;24 hours on a general internal medicine ward&#xD;
&#xD;
          -  Informed consent as documented by signature&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Need for therapeutic anticoagulation (e.g., atrial fibrillation)&#xD;
&#xD;
          -  Life expectancy &lt;30 days&#xD;
&#xD;
          -  Insufficient proficiency of the German or French language&#xD;
&#xD;
          -  Unwilling to provide informed consent&#xD;
&#xD;
          -  Prior enrolment in the study&#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>Christine Baumgartner, MD, MAS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inselspital, Bern University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marie Méan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire Vaudois, University Hospital of Lausanne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inselspital, Bern University Hospital</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geneva University Hospital</name>
      <address>
        <city>Geneva</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Lausanne</name>
      <address>
        <city>Lausanne</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Venous thromboembolism</keyword>
  <keyword>Pulmonary embolism</keyword>
  <keyword>Deep vein thrombosis</keyword>
  <keyword>Risk factor</keyword>
  <keyword>Hospital-acquired</keyword>
  <keyword>Mobility</keyword>
  <keyword>Accelerometry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Embolism</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thromboembolism</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
    <mesh_term>Embolism and Thrombosis</mesh_term>
    <mesh_term>Mobility Limitation</mesh_term>
    <mesh_term>Iatrogenic Disease</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/NCT04439383
org study id: RISE
nct id: NCT04439383
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hospital-acquired venous thromboembolism (HA-VTE) is one of the leading preventable causes of
      in-hospital mortality, but prevention of VTE in hospitalized medical patients remains
      challenging, as preventive measures such as pharmacological thromboprophylaxis (TPX) need to
      be tailored to individual thrombotic risk.

      The broad objective of this project is to improve VTE prevention strategies in hospitalized
      medical patients by prospectively examining VTE risk factors (including mobility) and
      comparing existing risk assessment models.
observational model: Cohort
time perspective: Prospective
measure: Venous thromboembolism
time frame: Within 90 days of initial hospital admission
description: Symptomatic, objectively confirmed fatal and non-fatal hospital-acquired venous thromboembolism, including symptomatic distal and proximal deep vein thrombosis and pulmonary embolism after hospital admission
measure: Venous thromboembolism
time frame: During the initial hospitalization, an average of 7 days
description: Symptomatic, objectively confirmed fatal and non-fatal hospital-acquired venous thromboembolism, including symptomatic distal and proximal deep vein thrombosis and pulmonary embolism during hospitalization
measure: All-cause mortality
time frame: During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission
description: All-cause mortality (all causes of death will be considered)
measure: Major bleeding
time frame: During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission
description: Major bleeding will be defined as fatal bleeding, symptomatic bleeding at critical sites (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, or intramuscular with compartment syndrome), or bleeding with a reduction of hemoglobin of at least 20 g/L or bleeding leading to transfusion of 2 or more units of packed red blood cells according to the definition of the International Society on Thrombosis and Haemostasis
measure: Clinically relevant non-major bleeding
time frame: During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission
description: Clinically relevant non-major bleeding, defined as overt bleeding that does not meet criteria for major bleeding but is associated with a medical intervention, unscheduled physician contact (visit or telephone call), or pain or impairment of activities of daily life
measure: Patient autonomy in the activities of daily living
time frame: At discharge (an average of 7 days after initial hospital admission) and at 90 days after admission
description: Patient autonomy in the activities of daily living as assessed by the modified Barthel Index
measure: Length of hospital stay
time frame: within 90 days of initial hospital admission
description: Length of hospital stay, defined as the time/date of discharge minus time/date of admission at the hospital ward
measure: Subsequent hospitalizations
time frame: Within 90 days of initial hospital admission
description: Subsequent hospitalization, defined as hospital readmissions
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christine Baumgartner, MD, MAS
role: Principal Investigator
affiliation: Inselspital, Bern University Hospital
last name: Marie Méan, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire Vaudois, University Hospital of Lausanne
facility: 
facility: 
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Pulmonary Embolism
mesh term: Thrombosis
mesh term: Embolism
mesh term: Thromboembolism
mesh term: Venous Thromboembolism
mesh term: Venous Thrombosis
mesh term: Embolism and Thrombosis
mesh term: Mobility Limitation
mesh term: Iatrogenic Disease
sharing ipd: No