<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/NCT03267823</url>
  </required_header>
  <id_info>
    <org_study_id>20170003</org_study_id>
    <nct_id>NCT03267823</nct_id>
  </id_info>
  <brief_title>INR Comparison Testing in Cardiac Surgery</brief_title>
  <official_title>Comparison of INR Determined by Point-of-Care to Standard Laboratory Testing Before and After Reversal of Heparin in Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</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>
      The investigator is testing blood samples to compare the results of two different techniques.&#xD;
      Since blood loss and the need for blood transfusions continue to be major problems after&#xD;
      heart surgery and other types of surgery, the blood clotting levels are constantly checked&#xD;
      during heart surgery as part of clinical care.The purpose of this study is to compare the INR&#xD;
      levels in blood before and after the heart bypass during surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">March 21, 2019</completion_date>
  <primary_completion_date type="Actual">March 21, 2019</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>Change in correlation between laboratory and point of care INR</measure>
    <time_frame>Baseline, Within ten minutes of completion of bypass</time_frame>
    <description>Pearson's Coefficient</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in agreement between laboratory and point of care INR</measure>
    <time_frame>Baseline, Within ten minutes of completion of bypass</time_frame>
    <description>Bland-Altman plots</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Coagulation Disorder</condition>
  <arm_group>
    <arm_group_label>Heart surgery</arm_group_label>
    <description>Patients undergoing heart surgery will have blood samples tested for INR values</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>International Normal Ratio (INR)</intervention_name>
    <description>Blood test for INR using laboratory and point of care methods</description>
    <arm_group_label>Heart surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing elective cardiac surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients greater than or equal to 18 years of age.&#xD;
&#xD;
          -  Patients undergoing elective surgery.&#xD;
&#xD;
          -  Patients undergoing cardiac surgery.&#xD;
&#xD;
          -  Patients to undergo general anesthesia with endotracheal intubation.&#xD;
&#xD;
          -  Patients with well-controlled health disorders.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients currently on Coumadin or other anticoagulants; including, direct thrombin&#xD;
             inhibitors and direct Xa inhibitors.&#xD;
&#xD;
          -  Patients who are under 18 years of age or pregnant.&#xD;
&#xD;
          -  Patients undergoing emergency surgery.&#xD;
&#xD;
          -  Patients with known coagulation disorders.&#xD;
&#xD;
          -  Patients who are unable to provide informed consent in the form of a signature&#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>Michael Fabbro, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>June 5, 2019</last_update_submitted>
  <last_update_submitted_qc>June 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Michael Fabbro</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Bleeding</keyword>
  <keyword>heart surgery</keyword>
  <keyword>coagulation</keyword>
  <keyword>coagulopathy</keyword>
  <keyword>INR</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</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/NCT03267823
org study id: 20170003
nct id: NCT03267823
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigator is testing blood samples to compare the results of two different techniques.
      Since blood loss and the need for blood transfusions continue to be major problems after
      heart surgery and other types of surgery, the blood clotting levels are constantly checked
      during heart surgery as part of clinical care.The purpose of this study is to compare the INR
      levels in blood before and after the heart bypass during surgery.
observational model: Cohort
time perspective: Prospective
measure: Change in correlation between laboratory and point of care INR
time frame: Baseline, Within ten minutes of completion of bypass
description: Pearson's Coefficient
measure: Change in agreement between laboratory and point of care INR
time frame: Baseline, Within ten minutes of completion of bypass
description: Bland-Altman plots
arm group label: Heart surgery
description: Patients undergoing heart surgery will have blood samples tested for INR values
intervention type: Diagnostic Test
intervention name: International Normal Ratio (INR)
description: Blood test for INR using laboratory and point of care methods
arm group label: Heart surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Fabbro, DO
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Michael Fabbro
investigator title: Assistant Professor
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
sharing ipd: No