<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/NCT04478136</url>
  </required_header>
  <id_info>
    <org_study_id>2019-10472</org_study_id>
    <nct_id>NCT04478136</nct_id>
  </id_info>
  <brief_title>Can Blood Panels Provide Early Warning of Bleeding in Patients on ECMO?</brief_title>
  <official_title>Can Blood Panels Provide Early Warning of Bleeding in Patients on ECMO?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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 prospective, observational study of 60 adult patients anticoagulated with&#xD;
      bivalirudin for extracorporeal membrane oxygenation (ECMO). The study aims to identify the&#xD;
      most precise early warning blood test or panel of blood tests to predict bleeding in patients&#xD;
      on bivalirudin/ECMO. The project will involve comparing currently used blood tests with an&#xD;
      extended panel of coagulation and metabolic blood tests with the aim of early warning of&#xD;
      impending bleeding to allow intervention in the form of adjusted bivalirudin dose,&#xD;
      modification of other risk factors, or transfusion with hemostatic products targeted to&#xD;
      documented coagulation test abnormalities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    This protocol was never initiated&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 1, 2021</start_date>
  <completion_date type="Anticipated">June 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 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>Number of participants with changes in extended blood panel (EBP) for each of the bleeding and non-bleeding patient groups.</measure>
    <time_frame>Up to 2 weeks</time_frame>
    <description>To determine if changes over time in an extended blood panel (EBP) and metabolic panel (MP) could provide early warning of impending bleeding in patients on ECMO.&#xD;
The extended blood panel includes: Dilute thrombin time (DTT), Factor XIII, Factor VIII, Factor IX, and Von Willebrand Disease (VWD) panel, and Factor XI, Factor X, Factor VII, Factor V, Factor II, protein C, protein S, thromboelastogram (TEG), and TEG-platelet mapping).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants designated as major bleeders (MB)</measure>
    <time_frame>Up to 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants designated as non-major bleeders (NMB)</measure>
    <time_frame>Up to 2 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>ECMO</condition>
  <condition>Bleeding</condition>
  <arm_group>
    <arm_group_label>Major bleeders (MB)</arm_group_label>
    <description>Additional blood to be drawn from patients on ECMO who have a major bleeding event.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-major bleeders (NMB)</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood test of factor levels</intervention_name>
    <description>Blood draw from central line to check coagulation factors</description>
    <arm_group_label>Major bleeders (MB)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The population in this prospective cohort study will include sixty (60) adults 18 - 70&#xD;
        years who are anticoagulation (AC) with bivalirudin and placed on ECMO for cardiac and/or&#xD;
        respiratory failure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults 18 - 70 years who are anticoagulation (AC) with bivalirudin and placed on ECMO&#xD;
             for cardiac and/or respiratory failure. Surgical and non-surgical patients will be&#xD;
             included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known pre-existing bleeding disorder (due to a factor deficiency that requires factor&#xD;
             replacement, or platelet disorder), or a creatinine &gt; 2.0.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kiri Mackersey, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Albert Einstein College</affiliation>
  </overall_official>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04478136
org study id: 2019-10472
nct id: NCT04478136
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a prospective, observational study of 60 adult patients anticoagulated with
      bivalirudin for extracorporeal membrane oxygenation (ECMO). The study aims to identify the
      most precise early warning blood test or panel of blood tests to predict bleeding in patients
      on bivalirudin/ECMO. The project will involve comparing currently used blood tests with an
      extended panel of coagulation and metabolic blood tests with the aim of early warning of
      impending bleeding to allow intervention in the form of adjusted bivalirudin dose,
      modification of other risk factors, or transfusion with hemostatic products targeted to
      documented coagulation test abnormalities.
observational model: Cohort
time perspective: Prospective
measure: Number of participants with changes in extended blood panel (EBP) for each of the bleeding and non-bleeding patient groups.
time frame: Up to 2 weeks
description: To determine if changes over time in an extended blood panel (EBP) and metabolic panel (MP) could provide early warning of impending bleeding in patients on ECMO.
The extended blood panel includes: Dilute thrombin time (DTT), Factor XIII, Factor VIII, Factor IX, and Von Willebrand Disease (VWD) panel, and Factor XI, Factor X, Factor VII, Factor V, Factor II, protein C, protein S, thromboelastogram (TEG), and TEG-platelet mapping).
measure: Number of participants designated as major bleeders (MB)
time frame: Up to 2 weeks
measure: Number of participants designated as non-major bleeders (NMB)
time frame: Up to 2 weeks
arm group label: Major bleeders (MB)
description: Additional blood to be drawn from patients on ECMO who have a major bleeding event.
arm group label: Non-major bleeders (NMB)
intervention type: Diagnostic Test
intervention name: Blood test of factor levels
description: Blood draw from central line to check coagulation factors
arm group label: Major bleeders (MB)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Kiri Mackersey, MBChB
role: Principal Investigator
affiliation: Albert Einstein College
responsible party type: Sponsor
mesh term: Hemorrhage
sharing ipd: No