<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/NCT03245502</url>
  </required_header>
  <id_info>
    <org_study_id>1297</org_study_id>
    <nct_id>NCT03245502</nct_id>
  </id_info>
  <brief_title>The Effect of Blood Transfusion on Venoarterial PCO2 Difference in Cardiac Surgery</brief_title>
  <official_title>The Effect of Blood Transfusion on Venoarterial PCO2 Difference in Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Turkiye Yuksek Ihtisas Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Turkiye Yuksek Ihtisas Education and Research Hospital</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>
      Venoarterial CO2 difference(delta PCO2), lactate, central venous oxygen saturation(ScVO2)&#xD;
      will be recorded in several steps in coronary artery bypass graft and valvular cardiac&#xD;
      operations. The patients will be divided into two groups as Transfused, and Non-Transfused&#xD;
      Groups observationally. The trend of delta CO2, lactate, ScVO2, postoperative creatinine&#xD;
      values, postoperative complications and 28 days mortality will be compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preoperative creatinine values, demographic data, comorbidities will be recorded in ASA I-II&#xD;
      elective coronary artery and valvular cardiac surgery patients. Intraoperative delta PCO2,&#xD;
      lactate, ScVO2 will be recorded in several steps. The patients will be divided into two&#xD;
      groups as Transfused, and Non-Transfused Groups observationally. The trend of delta CO2,&#xD;
      lactate, ScVO2, postoperative creatinine values, postoperative complications and 28 days&#xD;
      mortality will be compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 20, 2017</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">November 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Complication</measure>
    <time_frame>5 days</time_frame>
    <description>The postoperative neurologic, renal, hepatic, respiratory complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>28 days</time_frame>
    <description>mortality</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">127</enrollment>
  <condition>Cardiac Procedure Complication</condition>
  <arm_group>
    <arm_group_label>Transfused</arm_group_label>
    <description>Patients who have blood transfusion during cardiac surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Not-Transfused</arm_group_label>
    <description>Patients who don't have blood transfusion during cardiac surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood transfusion</intervention_name>
    <description>The transfusion of erythrocyte suspension</description>
    <arm_group_label>Transfused</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        18-75 years cardiac surgery patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective cardiac surgery, stable cardiac function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical signs of heart failure, symptomatic cerebral or peripheral failure,&#xD;
             uncontrolled diabetes mellitus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Demet Bölükbaşı, Specialist</last_name>
    <role>Study Chair</role>
    <affiliation>Turkiye Yuksek Ihtisas Education and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sema Turan, Asc prof</last_name>
    <role>Study Director</role>
    <affiliation>Turkiye Yuksek Ihtisas Education and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dilek Kazancı, Asc prof</last_name>
    <role>Study Chair</role>
    <affiliation>Turkiye Yuksek Ihtisas Education and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sultan Sevim Yakın, Specialist</last_name>
    <role>Study Chair</role>
    <affiliation>Turkiye Yuksek Ihtisas Education and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hija Yazıcıoğlu, Asc Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Turkiye Yuksek Ihtisas Education and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aysegül Özgok, Prof</last_name>
    <role>Study Director</role>
    <affiliation>Turkiye Yuksek Ihtisas Education and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Turkiye Yuksek Ihtisas Education and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06230</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>December 14, 2017</last_update_submitted>
  <last_update_submitted_qc>December 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Turkiye Yuksek Ihtisas Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Büşra Tezcan</investigator_full_name>
    <investigator_title>Specialist doctor</investigator_title>
  </responsible_party>
  <keyword>tissue oxygenation</keyword>
  <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/NCT03245502
org study id: 1297
nct id: NCT03245502
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Venoarterial CO2 difference(delta PCO2), lactate, central venous oxygen saturation(ScVO2)
      will be recorded in several steps in coronary artery bypass graft and valvular cardiac
      operations. The patients will be divided into two groups as Transfused, and Non-Transfused
      Groups observationally. The trend of delta CO2, lactate, ScVO2, postoperative creatinine
      values, postoperative complications and 28 days mortality will be compared.
Preoperative creatinine values, demographic data, comorbidities will be recorded in ASA I-II
      elective coronary artery and valvular cardiac surgery patients. Intraoperative delta PCO2,
      lactate, ScVO2 will be recorded in several steps. The patients will be divided into two
      groups as Transfused, and Non-Transfused Groups observationally. The trend of delta CO2,
      lactate, ScVO2, postoperative creatinine values, postoperative complications and 28 days
      mortality will be compared.
observational model: Case-Control
time perspective: Prospective
measure: Complication
time frame: 5 days
description: The postoperative neurologic, renal, hepatic, respiratory complications
measure: Mortality
time frame: 28 days
description: mortality
arm group label: Transfused
description: Patients who have blood transfusion during cardiac surgery
arm group label: Not-Transfused
description: Patients who don't have blood transfusion during cardiac surgery
intervention type: Biological
intervention name: Blood transfusion
description: The transfusion of erythrocyte suspension
arm group label: Transfused
blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
last name: Demet Bölükbaşı, Specialist
role: Study Chair
affiliation: Turkiye Yuksek Ihtisas Education and Research Hospital
last name: Sema Turan, Asc prof
role: Study Director
affiliation: Turkiye Yuksek Ihtisas Education and Research Hospital
last name: Dilek Kazancı, Asc prof
role: Study Chair
affiliation: Turkiye Yuksek Ihtisas Education and Research Hospital
last name: Sultan Sevim Yakın, Specialist
role: Study Chair
affiliation: Turkiye Yuksek Ihtisas Education and Research Hospital
last name: Hija Yazıcıoğlu, Asc Prof
role: Study Chair
affiliation: Turkiye Yuksek Ihtisas Education and Research Hospital
last name: Aysegül Özgok, Prof
role: Study Director
affiliation: Turkiye Yuksek Ihtisas Education and Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Turkiye Yuksek Ihtisas Education and Research Hospital
investigator full name: Büşra Tezcan
investigator title: Specialist doctor
sharing ipd: No