<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/NCT02979158</url>
  </required_header>
  <id_info>
    <org_study_id>DAPTUMU-123</org_study_id>
    <nct_id>NCT02979158</nct_id>
  </id_info>
  <brief_title>Preoperative Dual Antiplatelet Therapy: Platelet Function and Influence of Cardiopulmonary Bypass</brief_title>
  <official_title>Influence of Cardiopulmonary Bypass on Platelet Function in Patients With Preoperative Dual Antiplatelet Therapy:</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umeå University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Umeå University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients admitted for coronary artery bypass surgery taking antiplatelet medicine have an&#xD;
      increased risk for bleeding.&#xD;
&#xD;
      Present study aims to compare the platelet function in two patient groups using different&#xD;
      types of heart-lung machine methods.&#xD;
&#xD;
      It is assumed that one of the methods is superior verified by sensitive methods of testing&#xD;
      platelet function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Taking antiplatelet medication before cardiac surgery increases the risk for bleeding.&#xD;
&#xD;
      The surgical procedure and the use of a heart-lung machine may disturb the function of&#xD;
      platelets, why measures to protect the existing function of platelets are of prime concern.&#xD;
&#xD;
      The present study aims to compare how two types of heart-lung machine methods influence&#xD;
      platelet function in two groups of patients.&#xD;
&#xD;
      The platelet function will be tested before, during and after surgery by the use of two&#xD;
      independent methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">January 24, 2018</completion_date>
  <primary_completion_date type="Actual">January 24, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of platelet function following cardiopulmonary bypass using platelet aggregometry</measure>
    <time_frame>Test of platelet function will be analysed on arrival to the operating room, post cardiopulmonary bypass and on day 1 in the intensive care unit based on the area under the curve depited from the two employed aggremometers</time_frame>
    <description>Included aggregometry tests: Multiplate and Rotem Platelet</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative bleeding</measure>
    <time_frame>Postoperative bleeding 24 hrs</time_frame>
    <description>Blood loss 24 hrs post surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Cardiopulmonary Bypass</condition>
  <condition>Platelet Disorder</condition>
  <condition>Bleeding Disorder</condition>
  <condition>Platelet Dysfunction Due to Drugs</condition>
  <arm_group>
    <arm_group_label>CPB Low Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conduct of cardiopulmonary bypass using a low heparin dose verified by the activated clotting time at 250 s</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CPB High Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conduct of cardiopulmonary bypass using a high heparin dose verified by the activated clotting time at 480 s</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CPB Low Dose</intervention_name>
    <description>Performing CPB with low dose heparin and coated equipment</description>
    <arm_group_label>CPB Low Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CPB High Dose</intervention_name>
    <description>Performing CPB with high dose heparin and uncoated equipment</description>
    <arm_group_label>CPB High Dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients accepted for coronary bypass surgery with dual preoperative antiplatelet&#xD;
             therapy suspended less than 4 days prior to surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abnormal coagulation verified from preoperative assessments, platelet count &lt;100 000,&#xD;
             Warfarin medication and renal insufficiency (GFR &lt; 60 ml/min)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulf Näslund, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Publich Health and Clinical Medicin, Umeå University, Sweden</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Magnus Hedström, MD</last_name>
    <role>Study Director</role>
    <affiliation>Heart Centre Umeå University Hospital Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart Centre Umeå University Hospital</name>
      <address>
        <city>Umeå</city>
        <zip>S-901 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Olsson A, Alfredsson J, Hakansson E, Svedjeholm R, Berglund J, Berg S. Protamine reduces whole blood platelet aggregation after cardiopulmonary bypass. Scand Cardiovasc J. 2016;50(1):58-63. doi: 10.3109/14017431.2015.1099720. Epub 2015 Oct 20.</citation>
    <PMID>26402229</PMID>
  </reference>
  <reference>
    <citation>Mishra PK, Thekkudan J, Sahajanandan R, Gravenor M, Lakshmanan S, Fayaz KM, Luckraz H. The role of point-of-care assessment of platelet function in predicting postoperative bleeding and transfusion requirements after coronary artery bypass grafting. Ann Card Anaesth. 2015 Jan-Mar;18(1):45-51. doi: 10.4103/0971-9784.148321.</citation>
    <PMID>25566711</PMID>
  </reference>
  <reference>
    <citation>Mollnes TE, Videm V, Christiansen D, Bergseth G, Riesenfeld J, Hovig T. Platelet compatibility of an artificial surface modified with functionally active heparin. Thromb Haemost. 1999 Sep;82(3):1132-6.</citation>
    <PMID>10494777</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>March 26, 2018</last_update_submitted>
  <last_update_submitted_qc>March 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2018</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>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
    <mesh_term>Blood Platelet Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data will be shared after reviewing final results after study completion at this site and through publication in a scientific journal.</ipd_description>
  </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/NCT02979158
org study id: DAPTUMU-123
nct id: NCT02979158
lead sponsor: 
collaborator: 
has dmc: Yes
Patients admitted for coronary artery bypass surgery taking antiplatelet medicine have an
      increased risk for bleeding.

      Present study aims to compare the platelet function in two patient groups using different
      types of heart-lung machine methods.

      It is assumed that one of the methods is superior verified by sensitive methods of testing
      platelet function.
Taking antiplatelet medication before cardiac surgery increases the risk for bleeding.

      The surgical procedure and the use of a heart-lung machine may disturb the function of
      platelets, why measures to protect the existing function of platelets are of prime concern.

      The present study aims to compare how two types of heart-lung machine methods influence
      platelet function in two groups of patients.

      The platelet function will be tested before, during and after surgery by the use of two
      independent methods.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Assessment of platelet function following cardiopulmonary bypass using platelet aggregometry
time frame: Test of platelet function will be analysed on arrival to the operating room, post cardiopulmonary bypass and on day 1 in the intensive care unit based on the area under the curve depited from the two employed aggremometers
description: Included aggregometry tests: Multiplate and Rotem Platelet
measure: Postoperative bleeding
time frame: Postoperative bleeding 24 hrs
description: Blood loss 24 hrs post surgery
arm group label: CPB Low Dose
arm group type: Experimental
description: Conduct of cardiopulmonary bypass using a low heparin dose verified by the activated clotting time at 250 s
arm group label: CPB High Dose
arm group type: Experimental
description: Conduct of cardiopulmonary bypass using a high heparin dose verified by the activated clotting time at 480 s
intervention type: Procedure
intervention name: CPB Low Dose
description: Performing CPB with low dose heparin and coated equipment
arm group label: CPB Low Dose
intervention type: Procedure
intervention name: CPB High Dose
description: Performing CPB with high dose heparin and uncoated equipment
arm group label: CPB High Dose
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Ulf Näslund, MD PhD
role: Principal Investigator
affiliation: Department of Publich Health and Clinical Medicin, Umeå University, Sweden
last name: Magnus Hedström, MD
role: Study Director
affiliation: Heart Centre Umeå University Hospital Sweden
facility: 
country: Sweden
citation: Olsson A, Alfredsson J, Hakansson E, Svedjeholm R, Berglund J, Berg S. Protamine reduces whole blood platelet aggregation after cardiopulmonary bypass. Scand Cardiovasc J. 2016;50(1):58-63. doi: 10.3109/14017431.2015.1099720. Epub 2015 Oct 20.
PMID: 26402229
citation: Mishra PK, Thekkudan J, Sahajanandan R, Gravenor M, Lakshmanan S, Fayaz KM, Luckraz H. The role of point-of-care assessment of platelet function in predicting postoperative bleeding and transfusion requirements after coronary artery bypass grafting. Ann Card Anaesth. 2015 Jan-Mar;18(1):45-51. doi: 10.4103/0971-9784.148321.
PMID: 25566711
citation: Mollnes TE, Videm V, Christiansen D, Bergseth G, Riesenfeld J, Hovig T. Platelet compatibility of an artificial surface modified with functionally active heparin. Thromb Haemost. 1999 Sep;82(3):1132-6.
PMID: 10494777
responsible party type: Sponsor
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
mesh term: Blood Platelet Disorders
sharing ipd: Undecided
ipd description: Data will be shared after reviewing final results after study completion at this site and through publication in a scientific journal.