<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/NCT01675817</url>
  </required_header>
  <id_info>
    <org_study_id>R-10-190</org_study_id>
    <secondary_id>16949E</secondary_id>
    <nct_id>NCT01675817</nct_id>
  </id_info>
  <brief_title>Evaluation of Heparin Rebound in Cardiac Surgery</brief_title>
  <official_title>Evaluation of Heparin Rebound in Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Academic Medical Organization of Southwestern Ontario</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent work has shown that heparin rebound is common after cardiac surgery.&#xD;
&#xD;
      The exact doze of protamine required to neutralize heparin at the end of CPB is unknown.&#xD;
      Besides, the precise doze of protamine to treat heparin rebound is also unknown. It is also&#xD;
      unknown if precise titration of protamine perioperatively in cardiac surgery can influence&#xD;
      transfusion requirements after cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will assess how much protamine is required to neutralize residual heparin&#xD;
      perioperatively in cardiac surgery through measurement of functional assays of heparin&#xD;
      (anti-Xa and anti-IIa levels). In the first phase of this study, protamine titration assays&#xD;
      will be carried out on normal pooled plasma incubated with heparin in the laboratory.&#xD;
&#xD;
      Once the correct dose of protamine required to neutralize the heparin is established in the&#xD;
      laboratory, the second phase will begin. Herein, plasma samples from patients undergoing&#xD;
      cardiac surgery (with anticoagulation with two different commercial preparations of heparin)&#xD;
      will be evaluated for residual heparin (Anti-Xa and anti-IIa levels). Protamine titration&#xD;
      assays wil then be carried out in vitro to assess neutralization of heparin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Actual">20</enrollment>
  <condition>Coagulation Delay</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing elective cardiac surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Written consent&#xD;
&#xD;
          -  Scheduled for cardiac surgery under CPB (cardiopulmonary bypass)--(elective or&#xD;
             emergency)&#xD;
&#xD;
          -  10 patients undergoing cardiac surgery where CPB time is anticipated to be short&#xD;
             (isolated primary CABG (coronary artery bypass graft);isolated mitral-valve repair or&#xD;
             aortic-valve replacement)&#xD;
&#xD;
          -  10 patients undergoing cardiac surgery where CPB time is anticipated to be longer&#xD;
             (CABG + valve surgery combined; reoperations)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known coagulopathies&#xD;
&#xD;
          -  Liver dysfunction&#xD;
&#xD;
          -  Patients receiving unfractionated or low molecular weight heparin thrombin inhibitors,&#xD;
             warfarin, antiplatelets within the past 7 days&#xD;
&#xD;
          -  Patients expected to undergo hypothermic CPB or circulatory arrest&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ravi Taneja, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lawson Health Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr. Ravi Taneja</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>September 23, 2019</last_update_submitted>
  <last_update_submitted_qc>September 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>heparin rebound</keyword>
  <keyword>protamine</keyword>
  <keyword>cardiopulmonary bypass</keyword>
  <keyword>cardiac surgery</keyword>
  <keyword>anti-Xa</keyword>
  <keyword>anti-IIa</keyword>
  <!-- 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/NCT01675817
org study id: R-10-190
secondary id: 16949E
nct id: NCT01675817
lead sponsor: 
collaborator: 
has dmc: No
Recent work has shown that heparin rebound is common after cardiac surgery.

      The exact doze of protamine required to neutralize heparin at the end of CPB is unknown.
      Besides, the precise doze of protamine to treat heparin rebound is also unknown. It is also
      unknown if precise titration of protamine perioperatively in cardiac surgery can influence
      transfusion requirements after cardiac surgery.
This study will assess how much protamine is required to neutralize residual heparin
      perioperatively in cardiac surgery through measurement of functional assays of heparin
      (anti-Xa and anti-IIa levels). In the first phase of this study, protamine titration assays
      will be carried out on normal pooled plasma incubated with heparin in the laboratory.

      Once the correct dose of protamine required to neutralize the heparin is established in the
      laboratory, the second phase will begin. Herein, plasma samples from patients undergoing
      cardiac surgery (with anticoagulation with two different commercial preparations of heparin)
      will be evaluated for residual heparin (Anti-Xa and anti-IIa levels). Protamine titration
      assays wil then be carried out in vitro to assess neutralization of heparin.
observational model: Other
time perspective: Prospective
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Ravi Taneja, MD, FRCPC
role: Principal Investigator
affiliation: Lawson Health Research Institute
facility: 
country: Canada
responsible party type: Sponsor