<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/NCT02191449</url>
  </required_header>
  <id_info>
    <org_study_id>KUH1160068</org_study_id>
    <nct_id>NCT02191449</nct_id>
  </id_info>
  <brief_title>The Influence of Preoperative Warfarin Medication on Thromboelastography and Blood Transfusion</brief_title>
  <official_title>Influence of Warfarin on Thromboelastography and Transfusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Konkuk University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Konkuk University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Warfarin therapy is usually monitored using the international normalized ratio (INR), and&#xD;
      prolonged INR means coagulation impairment that can leads elevating transfusion requirement&#xD;
      after operation. This study was designed to assess the relationships with warfarin and TEG&#xD;
      values related to transfusion amount, to set up blood transfusion strategy in patients on&#xD;
      atrial fibrillation undergoing cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was a retrospective evaluation of patients who have received cardiac surgery with&#xD;
      Maze-operation from March 2008 to November 2013.&#xD;
&#xD;
      Patients who have atrial fibrillation undergoing cardiac surgery with Maze-operation were&#xD;
      included.&#xD;
&#xD;
      The following exclusion criteria are applied:&#xD;
&#xD;
        1. Patients who have taken medicine related to coagulation (such as antiplatelets like&#xD;
           aspirin and clopidogrel) except warfarin or bridged heparin&#xD;
&#xD;
        2. Patients whose laboratory values could not be confirmed by medical records review.&#xD;
&#xD;
      Patients were categorized by two groups.&#xD;
&#xD;
        1. W group: patients on atrial fibrillation who have taken warfarin for p.o medication.&#xD;
&#xD;
        2. C group: patients on atrial fibrillation who have not taken warfarin for p.o medication.&#xD;
&#xD;
      Using blood sample, authors examined as follows:&#xD;
&#xD;
        1. Preoperative (maximum 5days before operation) and postoperative (30min after ICU&#xD;
           admission) coagulation values with haematologic values: PT/aPTT, INR, Hb, Hct, platelet&#xD;
           levels.&#xD;
&#xD;
        2. ROTEM values at 30min after anaesthetic induction and 30min after ICU admission:&#xD;
           Clotting time (CT), clot formation time (CFT), maximum clot firmness (MCF), maximum&#xD;
           lysis (ML)&#xD;
&#xD;
        3. Intraoperative (during operation) and postoperative (during admission, an expected&#xD;
           average of 5 weeks) total transfusion amount: RBC, FFP, PC, cryoprecipitate.&#xD;
&#xD;
        4. Post operative 24 hr bleeding amount in the chest tube drain bottle.&#xD;
&#xD;
        5. The duration (maximum 2 weeks) of warfarin discontinuation. (in W group)&#xD;
&#xD;
      Statistical analysis was performed using unpaired t-test and chi-square test to compare&#xD;
      patients demographic data and other parameters. To determine the relationship of INR and&#xD;
      ROTEM parameters with bleeding amount and transfusion amount, multiple linear regression&#xD;
      model that accounted for all confounder variables was used. For each factor in the multiple&#xD;
      regression model, variables with a p value of less than 0.10 were kept in the final model.&#xD;
      The data was analyzed using the program Statistical Package for the Social Sciences ver. 18.0&#xD;
      (SPSS Inc, Chicago, USA). A value of p &lt; 0.05 was considered statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rotational Thromboelastography : Clotting time (CT)</measure>
    <time_frame>30min after anesthetic induction and 15 mins after CPB weaning status</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rotational Thromboelastography : clot formation time (CFT)</measure>
    <time_frame>30min after anesthetic induction and 15 mins after CPB weaning status</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Rotational Thromboelastography : maximum clot firmness (MCF)</measure>
    <time_frame>30min after anesthetic induction and 15 mins after CPB weaning status</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Rotational Thromboelastography : maximum lysis (ML) level Rotational Thromboelastography : maximum lysis (ML) level</measure>
    <time_frame>30min after anesthetic induction and 15 mins after CPB weaning status</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>amount of Blood transfusion</measure>
    <time_frame>intraoperative (during operation) and postoperative (during admission, an expected average of 5 weeks)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Coagulation values : preprothrombin time (PT)</measure>
    <time_frame>preoperative (maximum 5days before operation) and postoperative (30min after ICU admission)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Coagulation values : activated partial thromboplastin time (aPTT)</measure>
    <time_frame>preoperative (maximum 5days before operation) and postoperative (30min after ICU admission)</time_frame>
  </other_outcome>
  <enrollment type="Actual">107</enrollment>
  <condition>Atrial Fibrillation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing cardiac surgery with Maze-operation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Patients who have atrial fibrillation undergoing cardiac surgery with Maze-operation.&#xD;
&#xD;
          -  W group : Patients who have had warfarin therapy before operation due to treat Atrial&#xD;
             fibrillation&#xD;
&#xD;
          -  C group : Patients who have not had warfarin therapy before operation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Patients who have taken medicine related to coagulation (such as antiplatelets like&#xD;
             aspirin and clopidogrel) except warfarin or bridged heparin.&#xD;
&#xD;
          -  2. Patients whose laboratory values could not be confirmed by medical records review.&#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>Seong-Hyop Kim, M.D,Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Konkuk University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Konkuk University Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>143-729</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>June 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>February 23, 2015</last_update_submitted>
  <last_update_submitted_qc>February 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 25, 2015</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>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <!-- 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/NCT02191449
org study id: KUH1160068
nct id: NCT02191449
lead sponsor: 
has dmc: Yes
Warfarin therapy is usually monitored using the international normalized ratio (INR), and
      prolonged INR means coagulation impairment that can leads elevating transfusion requirement
      after operation. This study was designed to assess the relationships with warfarin and TEG
      values related to transfusion amount, to set up blood transfusion strategy in patients on
      atrial fibrillation undergoing cardiac surgery.
This study was a retrospective evaluation of patients who have received cardiac surgery with
      Maze-operation from March 2008 to November 2013.

      Patients who have atrial fibrillation undergoing cardiac surgery with Maze-operation were
      included.

      The following exclusion criteria are applied:

        1. Patients who have taken medicine related to coagulation (such as antiplatelets like
           aspirin and clopidogrel) except warfarin or bridged heparin

        2. Patients whose laboratory values could not be confirmed by medical records review.

      Patients were categorized by two groups.

        1. W group: patients on atrial fibrillation who have taken warfarin for p.o medication.

        2. C group: patients on atrial fibrillation who have not taken warfarin for p.o medication.

      Using blood sample, authors examined as follows:

        1. Preoperative (maximum 5days before operation) and postoperative (30min after ICU
           admission) coagulation values with haematologic values: PT/aPTT, INR, Hb, Hct, platelet
           levels.

        2. ROTEM values at 30min after anaesthetic induction and 30min after ICU admission:
           Clotting time (CT), clot formation time (CFT), maximum clot firmness (MCF), maximum
           lysis (ML)

        3. Intraoperative (during operation) and postoperative (during admission, an expected
           average of 5 weeks) total transfusion amount: RBC, FFP, PC, cryoprecipitate.

        4. Post operative 24 hr bleeding amount in the chest tube drain bottle.

        5. The duration (maximum 2 weeks) of warfarin discontinuation. (in W group)

      Statistical analysis was performed using unpaired t-test and chi-square test to compare
      patients demographic data and other parameters. To determine the relationship of INR and
      ROTEM parameters with bleeding amount and transfusion amount, multiple linear regression
      model that accounted for all confounder variables was used. For each factor in the multiple
      regression model, variables with a p value of less than 0.10 were kept in the final model.
      The data was analyzed using the program Statistical Package for the Social Sciences ver. 18.0
      (SPSS Inc, Chicago, USA). A value of p < 0.05 was considered statistically significant.
observational model: Cohort
time perspective: Retrospective
measure: Rotational Thromboelastography : Clotting time (CT)
time frame: 30min after anesthetic induction and 15 mins after CPB weaning status
measure: Rotational Thromboelastography : clot formation time (CFT)
time frame: 30min after anesthetic induction and 15 mins after CPB weaning status
measure: Rotational Thromboelastography : maximum clot firmness (MCF)
time frame: 30min after anesthetic induction and 15 mins after CPB weaning status
measure: Rotational Thromboelastography : maximum lysis (ML) level Rotational Thromboelastography : maximum lysis (ML) level
time frame: 30min after anesthetic induction and 15 mins after CPB weaning status
measure: amount of Blood transfusion
time frame: intraoperative (during operation) and postoperative (during admission, an expected average of 5 weeks)
measure: Coagulation values : preprothrombin time (PT)
time frame: preoperative (maximum 5days before operation) and postoperative (30min after ICU admission)
measure: Coagulation values : activated partial thromboplastin time (aPTT)
time frame: preoperative (maximum 5days before operation) and postoperative (30min after ICU admission)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Seong-Hyop Kim, M.D,Ph.D
role: Principal Investigator
affiliation: Konkuk University Medical Center
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Atrial Fibrillation