<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/NCT03038893</url>
  </required_header>
  <id_info>
    <org_study_id>54321516.0.0000.5327</org_study_id>
    <nct_id>NCT03038893</nct_id>
  </id_info>
  <brief_title>Point of Care Ultrasound For The Diagnosis Of Deep Venous Thrombosis And Its Effect On Length Of Hospital Stay</brief_title>
  <official_title>Point of Care Ultrasound For The Diagnosis Of Deep Venous Thrombosis And Its Effect On Length Of Hospital Stay</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</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>
      This is a Clinical Trial on the use of Point Of Care Ultrasound for the diagnosis of deep&#xD;
      venous thrombosis (DVT) and its effect on length of hospital stay. 25 participants with&#xD;
      suspicion of DVT according to Wells Criteria were randomized to one of two groups: Point of&#xD;
      Care Ultrasound and Echo Doppler Ultrasound (POCUS + EDUS), and the control group was&#xD;
      submitted only to the Echo Doppler Ultrasound (EDUS). The primary outcome was hospital stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Because of high mortality associated with venous thrombosis (pulmonary embolism and deep&#xD;
      venous thrombosis - DVT) the early recognition and therapeutics of its condition are crucial.&#xD;
      Point of Care Ultrasound (POCUS) is a method with high sensibility to diagnose DVT and it is&#xD;
      as accurate as Echo Doppler Ultrasound (EDUS), however the use of POCUS for diagnosis of DVT&#xD;
      in the emergency care still presents resistance. This is a Clinical Trial on the use of POCUS&#xD;
      for the diagnosis of DVT and its effect on length of hospital stay. 25 participants were&#xD;
      randomized into two groups. The randomization was done through the random.org site in blocks&#xD;
      of 4, a randomization list was with one researcher (blind) of the study. The experimental&#xD;
      group was first submitted to POCUS in the Emergency Room, performed by a resident physician&#xD;
      of Internal Medicine with training in POCUS, then after submitted to EDUS in the Radiology&#xD;
      Service by a Radiologist. The control group was submitted only to EDUS in the Radiology&#xD;
      Service. The 2-point compression technique was used, as described in previous studies, using&#xD;
      the portable ultrasound device (M-turbo Sonosite) with a high frequency linear transducer&#xD;
      (5-10 MHZ). The sites used in the evaluation were the popliteal site comprising the popliteal&#xD;
      vein and trifurcation of the popliteal vein and the femoral point in which comprises the&#xD;
      sapheno-femoral junction, the common femoral vein and the superficial femoral vein, all&#xD;
      evaluated in the transverse plane. The result was considered positive for DVT when the vessel&#xD;
      evaluated showed no compressibility and / or presented echogenic material in the lumen of the&#xD;
      vein. After the randomization, the patients were followed for a period of 30 days, being&#xD;
      evaluated in three moments: initial evaluation, at 7 and 30 days of the initial evaluation.&#xD;
      Whenever possible, each evaluation was in person. In the initial evaluation, the&#xD;
      participant's demographics, date and time of arrival at the Emergency Service, previous&#xD;
      illnesses, Wells criteria score and reason for the initial care were collected. Participants&#xD;
      randomized to the POCUS + EDUS group had recorded date and time of ultrasound at the bedside&#xD;
      and, if there was confirmation of DVT, these data were collected by the resident physician,&#xD;
      blinded for the Echo Doppler Ultrasound results. EDUS data, such as date and time of the&#xD;
      examination request, date and time of the release of the exam report, confirmation of DVT,&#xD;
      date and time of discharge were collected by another researcher, blinded to the participant's&#xD;
      group and to the POCUS's results. After 7 and 30 days the outcomes were recorded: time for a&#xD;
      first diagnostic information, time to therapeutic decision making / prescription, length of&#xD;
      hospital stay, death, pulmonary thromboembolism, bleeding or other complication,&#xD;
      re-hospitalization, evolution to DVT in cases that were initially negative.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Actual">January 30, 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Single Blind Masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Length of hospital stay</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to first diagnostic information</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Time to first diagnostic information</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to therapeutic decision making / prescription</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Time to therapeutic decision making / prescription</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Deep Venous Thromboses</condition>
  <condition>Deep Venous Thrombosis of Left Leg</condition>
  <condition>Deep Venous Thrombosis of Right Leg</condition>
  <condition>Deep Venous Thrombosis Proximal</condition>
  <arm_group>
    <arm_group_label>POCUS + EDUS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients were first submitted to Point Of Care Ultrasound (POCUS) and then to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Echo Doppler Ultrasound (EDUS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients were submitted only to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Point Of Care Ultrasound (PODUS)</intervention_name>
    <description>Patients were first submitted to Point Of Care Ultrasound (POCUS) and then to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.</description>
    <arm_group_label>POCUS + EDUS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Echo Doppler Ultrasound (EDUS)</intervention_name>
    <description>Patients were submitted only to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.</description>
    <arm_group_label>Echo Doppler Ultrasound (EDUS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Low, moderate or high suspicion of DVT by Wells Criteria.&#xD;
&#xD;
          -  Patients with Echo-Doppler Ultrasonography already requested in the hospital system.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Myocardial Infarction, Stroke or Cardiac Surgery within 3 months prior to hospital&#xD;
             admission;&#xD;
&#xD;
          -  Renal Chronic Disease (Clinical Stages IV and V);&#xD;
&#xD;
          -  Congestive Heart Failure (NYHA IV);&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Previous episode of DVT in the same leg that of the current DVT suspicion;&#xD;
&#xD;
          -  Patients already in treatment for DVT or taking anticoagulants for any other reason.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ana Claudia Tonelli</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clinicas de Porto Alegre</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ultrasonography</keyword>
  <keyword>Point-of-care systems</keyword>
  <keyword>Deep venous thrombosis</keyword>
  <keyword>Hospitalization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03038893
org study id: 54321516.0.0000.5327
nct id: NCT03038893
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a Clinical Trial on the use of Point Of Care Ultrasound for the diagnosis of deep
      venous thrombosis (DVT) and its effect on length of hospital stay. 25 participants with
      suspicion of DVT according to Wells Criteria were randomized to one of two groups: Point of
      Care Ultrasound and Echo Doppler Ultrasound (POCUS + EDUS), and the control group was
      submitted only to the Echo Doppler Ultrasound (EDUS). The primary outcome was hospital stay.
Because of high mortality associated with venous thrombosis (pulmonary embolism and deep
      venous thrombosis - DVT) the early recognition and therapeutics of its condition are crucial.
      Point of Care Ultrasound (POCUS) is a method with high sensibility to diagnose DVT and it is
      as accurate as Echo Doppler Ultrasound (EDUS), however the use of POCUS for diagnosis of DVT
      in the emergency care still presents resistance. This is a Clinical Trial on the use of POCUS
      for the diagnosis of DVT and its effect on length of hospital stay. 25 participants were
      randomized into two groups. The randomization was done through the random.org site in blocks
      of 4, a randomization list was with one researcher (blind) of the study. The experimental
      group was first submitted to POCUS in the Emergency Room, performed by a resident physician
      of Internal Medicine with training in POCUS, then after submitted to EDUS in the Radiology
      Service by a Radiologist. The control group was submitted only to EDUS in the Radiology
      Service. The 2-point compression technique was used, as described in previous studies, using
      the portable ultrasound device (M-turbo Sonosite) with a high frequency linear transducer
      (5-10 MHZ). The sites used in the evaluation were the popliteal site comprising the popliteal
      vein and trifurcation of the popliteal vein and the femoral point in which comprises the
      sapheno-femoral junction, the common femoral vein and the superficial femoral vein, all
      evaluated in the transverse plane. The result was considered positive for DVT when the vessel
      evaluated showed no compressibility and / or presented echogenic material in the lumen of the
      vein. After the randomization, the patients were followed for a period of 30 days, being
      evaluated in three moments: initial evaluation, at 7 and 30 days of the initial evaluation.
      Whenever possible, each evaluation was in person. In the initial evaluation, the
      participant's demographics, date and time of arrival at the Emergency Service, previous
      illnesses, Wells criteria score and reason for the initial care were collected. Participants
      randomized to the POCUS + EDUS group had recorded date and time of ultrasound at the bedside
      and, if there was confirmation of DVT, these data were collected by the resident physician,
      blinded for the Echo Doppler Ultrasound results. EDUS data, such as date and time of the
      examination request, date and time of the release of the exam report, confirmation of DVT,
      date and time of discharge were collected by another researcher, blinded to the participant's
      group and to the POCUS's results. After 7 and 30 days the outcomes were recorded: time for a
      first diagnostic information, time to therapeutic decision making / prescription, length of
      hospital stay, death, pulmonary thromboembolism, bleeding or other complication,
      re-hospitalization, evolution to DVT in cases that were initially negative.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
masking description: Single Blind Masking
measure: Length of hospital stay
time frame: Up to 30 days
description: Length of hospital stay
measure: Time to first diagnostic information
time frame: Up to 30 days
description: Time to first diagnostic information
measure: Time to therapeutic decision making / prescription
time frame: Up to 30 days
description: Time to therapeutic decision making / prescription
arm group label: POCUS + EDUS
arm group type: Experimental
description: Patients were first submitted to Point Of Care Ultrasound (POCUS) and then to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.
arm group label: Echo Doppler Ultrasound (EDUS)
arm group type: Active Comparator
description: Patients were submitted only to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.
intervention type: Diagnostic Test
intervention name: Point Of Care Ultrasound (PODUS)
description: Patients were first submitted to Point Of Care Ultrasound (POCUS) and then to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.
arm group label: POCUS + EDUS
intervention type: Diagnostic Test
intervention name: Echo Doppler Ultrasound (EDUS)
description: Patients were submitted only to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.
arm group label: Echo Doppler Ultrasound (EDUS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ana Claudia Tonelli
role: Principal Investigator
affiliation: Hospital de Clinicas de Porto Alegre
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Venous Thrombosis
sharing ipd: Undecided