<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/NCT04436575</url>
  </required_header>
  <id_info>
    <org_study_id>TMarkarian/Ecuhda</org_study_id>
    <nct_id>NCT04436575</nct_id>
  </id_info>
  <brief_title>Point-of-care Ultrasound Interest in Acute Gastrointestinal Bleeding Emergency Department Patients</brief_title>
  <official_title>Interest of Clinical Ultrasound in Patients Consulting for Acute Gastrointestinal Bleeding in the Emergency Department: an Observational Monocentric Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SUD Association pour le Développement de la Recherche et de lEnseignement</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SUD Association pour le Développement de la Recherche et de lEnseignement</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>
      Acute Gastrointestinal (GI) Bleeding are a common chief complaint among Emergency Department.&#xD;
      The mortality rate for Lower GI Bleeding is 3.9%. While the mortality rate can be as high as&#xD;
      10% for Upper GI Bleeding. Most existing scores take into account hemodynamic parameters such&#xD;
      as systolic blood pressure or heart rate. Studies have shown that hemodynamic instability&#xD;
      only develops late in the course of a bleed, as evidenced by a blood depletion of 30 to 40%&#xD;
      of the total blood volume. Currently, few studies have examined the value of echocardiography&#xD;
      in the management of patients presenting for Acute GI Bleeding in the Emergency Department.&#xD;
      The main objective of this study is to show whether simple ultrasound parameters can,&#xD;
      combined with clinico biological parameters, predict in an early manner the evolution of the&#xD;
      patient presenting to the Emergency Department for Acute Gastrointestinal Bleeding.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">November 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2021</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>Correlation of ultrasound parameters with the occurrence of adverse events</measure>
    <time_frame>1 day</time_frame>
    <description>The primary outcome was to determine the correlation of echocardiography parameters to detect adverse events (AEs). Echocardiography parameters included signs of severe hypovolemia (end systolic left ventricular obliteration and/or complete inspiratory collapse of the inferior vena cava and/or E velocity &lt; 0.7 m/s). Adverse events were defined as blood transfusion, therapeutic intervention to control haemorrhage (endoscopic, radiologic or surgical hemostasis), rebleeding and in-hospital mortality.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Echocardiography and clinical scores</measure>
    <time_frame>1 day</time_frame>
    <description>Correlation of echocardiographic signs of severe hypovolemia (end systolic left ventricular obliteration and/or complete inspiratory collapse of the inferior vena cava and/or E velocity &lt; 0.7 m/s) with existing clinical scores (Glasgow-Blatchford bleeding score and Rockall score).&#xD;
The Glasgow-Blatchford bleeding score includes measurements of hemoglobin in grams per deciliter, blood urea nitrogen in millimoles per liter, initial systolic blood pressure in millimeters of mercury, sex, heart rate in beats per minute, melena present, recent syncope, hepatic disease history and cardiac failure present.&#xD;
The Rockall score includes measurement of age, shock present, comorbidities, diagnosis and major stigmata of recent hemorrhage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other ultrasound parameters with the occurrence of adverse events</measure>
    <time_frame>1 day</time_frame>
    <description>The correlation of other echocardiography parameters (visual assess of the ejection fraction (in percentage) and E/A ratio (represents the ratio of peak velocity blood flow from left ventricular relaxation in early diastole = the E velocity in meter per second, to peak velocity flow in late diastole caused by atrial contraction = the A velocity in meter per second) and E' velocity (in centimeter per seconds) and ratio E/E' (ratio between early mitral inflow velocity = the E velocity in centimeter per second and mitral annular early diastolic velocity = the E' velocity in centimeter per second) and subaortic velocity time index (VTI in centimeter) with the occurrence of adverse events.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Acute Gastrointestinal Bleeding</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Point-of-care ultrasound</intervention_name>
    <description>Point-of-care ultrasound prognostic performance : echocardiography mainly</description>
    <other_name>Echocardiography</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients managed in investigative emergency department whose primary reason for&#xD;
        management is acute gastrointestinal bleeding may be included. Patients with&#xD;
        echocardiography are included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary reason for emergency Department admission is acute gastrointestinal bleeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Persons not benefiting from a social security scheme&#xD;
&#xD;
          -  Persons deprived of liberty&#xD;
&#xD;
          -  Patient participates in another study&#xD;
&#xD;
          -  The patient is in a period of exclusion determined by a previous study.&#xD;
&#xD;
          -  The patient is under legal protection, guardianship or trusteeship.&#xD;
&#xD;
          -  Patient refuses to participate&#xD;
&#xD;
          -  It proves impossible to give informed information about the subject matter&#xD;
&#xD;
          -  The patient is not fluent in French.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>MARKARIAN Thibaut</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Thibaut Markarian, MD</last_name>
      <phone>+33413429732</phone>
      <email>thibaut.markarian@ap-hm.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>SUD Association pour le Développement de la Recherche et de lEnseignement</investigator_affiliation>
    <investigator_full_name>Thibaut MARKARIAN</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>emergency department</keyword>
  <keyword>acute gastrointestinal bleeding</keyword>
  <keyword>echocardiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Hemorrhage</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Hemorrhage</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/NCT04436575
org study id: TMarkarian/Ecuhda
nct id: NCT04436575
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acute Gastrointestinal (GI) Bleeding are a common chief complaint among Emergency Department.
      The mortality rate for Lower GI Bleeding is 3.9%. While the mortality rate can be as high as
      10% for Upper GI Bleeding. Most existing scores take into account hemodynamic parameters such
      as systolic blood pressure or heart rate. Studies have shown that hemodynamic instability
      only develops late in the course of a bleed, as evidenced by a blood depletion of 30 to 40%
      of the total blood volume. Currently, few studies have examined the value of echocardiography
      in the management of patients presenting for Acute GI Bleeding in the Emergency Department.
      The main objective of this study is to show whether simple ultrasound parameters can,
      combined with clinico biological parameters, predict in an early manner the evolution of the
      patient presenting to the Emergency Department for Acute Gastrointestinal Bleeding.
observational model: Cohort
time perspective: Prospective
measure: Correlation of ultrasound parameters with the occurrence of adverse events
time frame: 1 day
description: The primary outcome was to determine the correlation of echocardiography parameters to detect adverse events (AEs). Echocardiography parameters included signs of severe hypovolemia (end systolic left ventricular obliteration and/or complete inspiratory collapse of the inferior vena cava and/or E velocity < 0.7 m/s). Adverse events were defined as blood transfusion, therapeutic intervention to control haemorrhage (endoscopic, radiologic or surgical hemostasis), rebleeding and in-hospital mortality.
measure: Echocardiography and clinical scores
time frame: 1 day
description: Correlation of echocardiographic signs of severe hypovolemia (end systolic left ventricular obliteration and/or complete inspiratory collapse of the inferior vena cava and/or E velocity < 0.7 m/s) with existing clinical scores (Glasgow-Blatchford bleeding score and Rockall score).
The Glasgow-Blatchford bleeding score includes measurements of hemoglobin in grams per deciliter, blood urea nitrogen in millimoles per liter, initial systolic blood pressure in millimeters of mercury, sex, heart rate in beats per minute, melena present, recent syncope, hepatic disease history and cardiac failure present.
The Rockall score includes measurement of age, shock present, comorbidities, diagnosis and major stigmata of recent hemorrhage.
measure: Other ultrasound parameters with the occurrence of adverse events
time frame: 1 day
description: The correlation of other echocardiography parameters (visual assess of the ejection fraction (in percentage) and E/A ratio (represents the ratio of peak velocity blood flow from left ventricular relaxation in early diastole = the E velocity in meter per second, to peak velocity flow in late diastole caused by atrial contraction = the A velocity in meter per second) and E' velocity (in centimeter per seconds) and ratio E/E' (ratio between early mitral inflow velocity = the E velocity in centimeter per second and mitral annular early diastolic velocity = the E' velocity in centimeter per second) and subaortic velocity time index (VTI in centimeter) with the occurrence of adverse events.
intervention type: Device
intervention name: Point-of-care ultrasound
description: Point-of-care ultrasound prognostic performance : echocardiography mainly
other name: Echocardiography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: SUD Association pour le Développement de la Recherche et de lEnseignement
investigator full name: Thibaut MARKARIAN
investigator title: Principal Investigator
mesh term: Gastrointestinal Hemorrhage
mesh term: Emergencies
mesh term: Hemorrhage
sharing ipd: No