<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/NCT03302195</url>
  </required_header>
  <id_info>
    <org_study_id>Obesity-CPB-21117</org_study_id>
    <nct_id>NCT03302195</nct_id>
  </id_info>
  <brief_title>Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery</brief_title>
  <official_title>Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Laval University</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>
      Standard Heparin management, based on total body weight, is not well established for obese&#xD;
      patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).&#xD;
&#xD;
      The purpose of this study is to assess the safety and efficacy of using lean body mass (LBM)&#xD;
      to determine pump flow rate and/or Heparin dosage in obese patients undergoing CPB.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 21, 2015</start_date>
  <completion_date type="Anticipated">December 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>
    <intervention_model_description>Randomized control prospective trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participant is blinded to group assignment</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Allogeneic transfusions of red blood cells</measure>
    <time_frame>Seven days post-operatively or until discharge, whichever comes first</time_frame>
    <description>Percentage of subjects avoiding any allogeneic transfusions of red blood cells</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Allogeneic transfusions of blood products</measure>
    <time_frame>Seven days post-operatively or until discharge, whichever comes first</time_frame>
    <description>Percentage of subjects avoiding any allogeneic transfusions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Units of blood product transfusions</measure>
    <time_frame>Seven days post-operatively or until discharge, whichever comes first</time_frame>
    <description>Number of units of transfused blood products</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Massive red blood cell transfusions</measure>
    <time_frame>Seven days post-operatively or until discharge, whichever comes first</time_frame>
    <description>Percentage of subjects avoiding massive red blood cell transfusion (more than 5 units)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative complications</measure>
    <time_frame>Post-operatively from day 0 up to first hospital discharge</time_frame>
    <description>Monitoring the safety of strategies by monitoring post-operative complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>Peroperative, 4 and 24 hours post-operative</time_frame>
    <description>Per- and post-operative bleeding</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">410</enrollment>
  <condition>Cardiopulmonary Bypass</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Heparin dose and cardiopulmonary bypass pump flow rate are calculated using total body weight.&#xD;
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Heparin dose is adjusted for lean body weight and cardiopulmonary bypass pump flow rate is calculated using total body weight.&#xD;
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Heparin dose is calculated using total body weight and cardiopulmonary bypass pump flow rate is adjusted for lean body weight.&#xD;
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Heparin dose and cardiopulmonary bypass pump flow rate are adjusted for lean body weight.&#xD;
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Heparin</intervention_name>
    <description>Based on patient body weight (UI/kg)</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Intervention group A</arm_group_label>
    <arm_group_label>Intervention group B</arm_group_label>
    <arm_group_label>Intervention group C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cardiopulmonary bypass pump flow rate</intervention_name>
    <description>Based on patient body weight (L/min/m2)</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Intervention group A</arm_group_label>
    <arm_group_label>Intervention group B</arm_group_label>
    <arm_group_label>Intervention group C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obese patients (BMI ≥ 30kg/m2)&#xD;
&#xD;
          -  Planned cardiac surgery&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Permanent pacemaker&#xD;
&#xD;
          -  Known intolerance to protamine&#xD;
&#xD;
          -  Known or suspected allergy to the used antifibrinolytic agent&#xD;
&#xD;
          -  Refusal to receive blood products&#xD;
&#xD;
          -  Planned off pump coronary artery bypass&#xD;
&#xD;
          -  Planned peri-operative use of desmopressin&#xD;
&#xD;
          -  Known Heparin-induced thrombocytopenia&#xD;
&#xD;
          -  Known deficiency in protein C, protein S, antithrombin or homozygous factor V Leiden&#xD;
&#xD;
          -  Known congenital bleeding disorders&#xD;
&#xD;
          -  Current endocarditis&#xD;
&#xD;
          -  Planned hypothermic circulatory arrest (&lt;28C)&#xD;
&#xD;
          -  Two or more cardiac surgery procedures&#xD;
&#xD;
          -  Emergency cardiac surgery procedures (medically required within 24hours of presenting&#xD;
             with acute symptoms)&#xD;
&#xD;
          -  Planned CPB priming with red blood cells&#xD;
&#xD;
          -  Any known autoimmune disease&#xD;
&#xD;
          -  Any history of stroke or non-coronary thrombotic disorders including deep venous&#xD;
             thrombosis and pulmonary embolism&#xD;
&#xD;
          -  Significant (≥50%) carotid artery stenosis&#xD;
&#xD;
          -  Patient dosed with low molecular weight Heparin less than 24h before surgery&#xD;
&#xD;
          -  Females of childbearing potential who are pregnant, breast-feeding or intend to become&#xD;
             pregnant or are not using adequate contraceptive methods&#xD;
&#xD;
          -  Confirmed ST elevation myocardial infarction (STEMI) within 7 days&#xD;
&#xD;
          -  Pre-operative platelet count &lt;100,000/microliter&#xD;
&#xD;
          -  Anaemia (Hematocrit &lt;32% for females, &lt;35%for males)&#xD;
&#xD;
          -  Dosed with clopidogrel or ticagrelor within the last 5 days prior to surgery, or&#xD;
             prasugrel within 7 days&#xD;
&#xD;
          -  Dosed with GPIIb/IIIa receptor blockers (Abciximab, Tirofiban, Eptifibatide) ≤ 24&#xD;
             hours prior to surgery&#xD;
&#xD;
          -  International ratio (INR) &gt;1.5 on the day of surgery in patients treated with vitamin&#xD;
             K antagonist&#xD;
&#xD;
          -  Liver dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)&#xD;
             increased ≥ 2-fold above the upper limit of local laboratory normal ranges)&#xD;
&#xD;
          -  Renal failure (creatinine ≥ 175 micromol/L or dialysis)&#xD;
&#xD;
          -  Current thromboembolic disease other than myocardial infarct&#xD;
&#xD;
          -  Patients who have pre-donated autologous blood&#xD;
&#xD;
          -  Patient presenting with a resistance to Heparin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre Voisine, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Laval</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hugo Tremblay, Bachelor</last_name>
    <phone>418-656-8711</phone>
    <phone_ext>3797</phone_ext>
    <email>hugo.tremblay@criucpq.ulaval.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hopital Laval</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hugo Tremblay, Bachelor</last_name>
      <phone>418-656-8711</phone>
      <phone_ext>3797</phone_ext>
      <email>hugo.tremblay@criucpq.ulaval.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laval University</investigator_affiliation>
    <investigator_full_name>Pierre Voisine</investigator_full_name>
    <investigator_title>Cardiac surgeon</investigator_title>
  </responsible_party>
  <keyword>Heparin</keyword>
  <keyword>Allogeneic blood product transfusions</keyword>
  <keyword>Bleeding</keyword>
  <keyword>Cardiac surgery</keyword>
  <keyword>Obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin</mesh_term>
  </intervention_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/NCT03302195
org study id: Obesity-CPB-21117
nct id: NCT03302195
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Standard Heparin management, based on total body weight, is not well established for obese
      patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).

      The purpose of this study is to assess the safety and efficacy of using lean body mass (LBM)
      to determine pump flow rate and/or Heparin dosage in obese patients undergoing CPB.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized control prospective trial
primary purpose: Treatment
masking: Single (Participant)
masking description: Participant is blinded to group assignment
measure: Allogeneic transfusions of red blood cells
time frame: Seven days post-operatively or until discharge, whichever comes first
description: Percentage of subjects avoiding any allogeneic transfusions of red blood cells
measure: Allogeneic transfusions of blood products
time frame: Seven days post-operatively or until discharge, whichever comes first
description: Percentage of subjects avoiding any allogeneic transfusions
measure: Units of blood product transfusions
time frame: Seven days post-operatively or until discharge, whichever comes first
description: Number of units of transfused blood products
measure: Massive red blood cell transfusions
time frame: Seven days post-operatively or until discharge, whichever comes first
description: Percentage of subjects avoiding massive red blood cell transfusion (more than 5 units)
measure: Post-operative complications
time frame: Post-operatively from day 0 up to first hospital discharge
description: Monitoring the safety of strategies by monitoring post-operative complications
measure: Bleeding
time frame: Peroperative, 4 and 24 hours post-operative
description: Per- and post-operative bleeding
arm group label: Control group
arm group type: Active Comparator
description: Heparin dose and cardiopulmonary bypass pump flow rate are calculated using total body weight.
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.
arm group label: Intervention group A
arm group type: Experimental
description: Heparin dose is adjusted for lean body weight and cardiopulmonary bypass pump flow rate is calculated using total body weight.
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.
arm group label: Intervention group B
arm group type: Experimental
description: Heparin dose is calculated using total body weight and cardiopulmonary bypass pump flow rate is adjusted for lean body weight.
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.
arm group label: Intervention group C
arm group type: Experimental
description: Heparin dose and cardiopulmonary bypass pump flow rate are adjusted for lean body weight.
An initial 400 IU/Kg Heparin dose will be administered, with an additional dose of 75 IU/kg if the activated clotting time remains below the 425 seconds target value. The cardiopulmonary bypass pump flow rate of 2.4 L/min/m2 of body surface area will be calculated.
intervention type: Drug
intervention name: Heparin
description: Based on patient body weight (UI/kg)
arm group label: Control group
arm group label: Intervention group A
arm group label: Intervention group B
arm group label: Intervention group C
intervention type: Procedure
intervention name: cardiopulmonary bypass pump flow rate
description: Based on patient body weight (L/min/m2)
arm group label: Control group
arm group label: Intervention group A
arm group label: Intervention group B
arm group label: Intervention group C
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre Voisine, MD
role: Principal Investigator
affiliation: University Laval
last name: Hugo Tremblay, Bachelor
phone: 418-656-8711
phone ext: 3797
email: hugo.tremblay@criucpq.ulaval.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Laval University
investigator full name: Pierre Voisine
investigator title: Cardiac surgeon
mesh term: Obesity
mesh term: Heparin
sharing ipd: No