<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/NCT03291769</url>
  </required_header>
  <id_info>
    <org_study_id>PHS01</org_study_id>
    <nct_id>NCT03291769</nct_id>
  </id_info>
  <brief_title>Effects of Intraoperative Blood and Blood Product Consumption on Postoperative Results in Pediatric Cardiac Surgery</brief_title>
  <official_title>Effects of Intraoperative Blood Transfusion on Postoperative Results in Pediatric Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cukurova University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cukurova 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>
      Blood products and intravenous fluids are frequently used in the treatment of children who&#xD;
      have undergone cardiac surgery in order to maintain hemodynamic stability. Optimal hematocrit&#xD;
      values during CPB are still being discussed in children undergoing congenital cardiac&#xD;
      surgery. The overall complication rate for transfusion in adults is 2.5 complications per&#xD;
      1000 units, while 10.7 complications per 1000 transfusion in children. The aim of this study&#xD;
      is to investigate the effects of the our transfusion strategies used in pediatric cardiac&#xD;
      surgery on duration of intensive care unit, duration of postoperative mechanical ventilation&#xD;
      and mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Blood products and intravenous fluids are frequently used in the treatment of&#xD;
      children who have undergone cardiac surgery in order to maintain hemodynamic stability.&#xD;
      Children undergoing cardiac surgery with cardiopulmonary bypass (CPB) are among the greatest&#xD;
      pediatric users of allogeneic red blood cells (RBCs), and transfusions are used in 79% of all&#xD;
      procedures. Optimal hematocrit values during CPB are still being discussed in children&#xD;
      undergoing congenital cardiac surgery. While it is argued that high hematocrit values provide&#xD;
      better results in perioperative period and postoperative neurological development, it is also&#xD;
      argued that blood products are associated with mortality and morbidity. The overall&#xD;
      complication rate for transfusion in adults is 2.5 complications per 1000 units, while 10.7&#xD;
      complications per 1000 transfusion in children.&#xD;
&#xD;
      Balancing the benefits and risks of blood transfusion is a particularly complex issue,&#xD;
      especially in children. Because many aspects of transfusion therapy in children are not well&#xD;
      researched.&#xD;
&#xD;
      Method: This prospective, observational study will be conducted following Cukurova University&#xD;
      Faculty of Medicine Ethics Committee approval. Children aged 16 years or younger who will&#xD;
      undergo open heart surgery due to congenital heart disease will be included in the study.&#xD;
      Patients with preoperative renal or hepatic disease will be excluded. Age, comorbidities,&#xD;
      history of previous operation will be recorded. Preoperative hematocrit, biochemical&#xD;
      parameters (blood urea nitrogen, creatinine, electrolytes), cardiac profile (angiography and&#xD;
      echocardiography reports, diagnosis of the disease requiring the surgery) and preoperative&#xD;
      medications, preoperative RACHS1 (risk adjustment for congenital heart disease, risk&#xD;
      management for congenital heart disease) will be recorded.&#xD;
&#xD;
      In the intraoperative period; the haematocrit values before CPB, during CPB, after CPB and&#xD;
      after reversal of the heparin with protamine will be recorded. Aortic cross clamp time, body&#xD;
      temperature, urine volume and diuretic use during CPB will be recorded. Blood gas values,&#xD;
      central venous oxygen saturation (SvO2) and lactate levels will be recorded in the&#xD;
      intraoperative period within 30 min intervals. The amount of crystalloid and colloid,&#xD;
      erythrocyte, fresh frozen plasma, platelet and cryoprecipitate used in the intraoperative&#xD;
      period will be recorded. The ACT (active coagulation time) values at the beginning and at the&#xD;
      end of the operation, the amount of applied heparin and protamine will be recorded.&#xD;
      Vasoactive agents (dopamine, dobutamine, adrenaline, nitroglycerin) used in the&#xD;
      intraoperative period will be recorded.&#xD;
&#xD;
      In the postoperative intensive care unit; blood gas and lactate values, hematocrit, chest&#xD;
      tube drainage and iv fluids (crystalloid and colloid) and blood products will be recorded at&#xD;
      postoperative 6th and 24th hours. The vasoactive agents, the inotrope score, the amount of&#xD;
      urine and the use of diuretics will be recorded. The length of stay in intensive care unit,&#xD;
      the duration of mechanical ventilation will be recorded.&#xD;
&#xD;
      Major complications will be identified as cardiac arrest, neurological deficit (stroke,&#xD;
      seizure), acute renal failure requiring dialysis therapy, arrhythmia requiring permanent&#xD;
      heart pace and multiple organ dysfunction and recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 25, 2018</start_date>
  <completion_date type="Actual">December 25, 2018</completion_date>
  <primary_completion_date type="Actual">August 25, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Months</target_duration>
  <primary_outcome>
    <measure>Length of stay in intensive care unit</measure>
    <time_frame>Postoperative 3 months</time_frame>
    <description>Postoperative length of stay in intensive care unit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Postoperative 3 months</time_frame>
    <description>Postoperative mortality</description>
  </secondary_outcome>
  <enrollment type="Actual">83</enrollment>
  <condition>Blood Loss, Surgical</condition>
  <condition>Pediatric Heart Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children aged 16 years or younger who will undergo heart surgery due to congenital heart&#xD;
        disease will be included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 16 years or younger who will undergo heart surgery due to congenital&#xD;
             heart disease will be included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with renal failure&#xD;
&#xD;
          -  Children with hepatic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>16 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Feri̇de Karacaer</last_name>
    <role>Study Director</role>
    <affiliation>Cukurova University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Feri̇de Karacaer</name>
      <address>
        <city>Adana</city>
        <state>In The USA Or Canada, Please Select...</state>
        <zip>01330</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Rizza A, Romagnoli S, Ricci Z. Fluid Status Assessment and Management During the Perioperative Phase in Pediatric Cardiac Surgery Patients. J Cardiothorac Vasc Anesth. 2016 Aug;30(4):1085-93. doi: 10.1053/j.jvca.2015.11.007. Epub 2015 Nov 10. No abstract available.</citation>
    <PMID>26944520</PMID>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>October 15, 2019</last_update_submitted>
  <last_update_submitted_qc>October 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cukurova University</investigator_affiliation>
    <investigator_full_name>Feride Karacaer</investigator_full_name>
    <investigator_title>Specialist doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Blood Loss, Surgical</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/NCT03291769
org study id: PHS01
nct id: NCT03291769
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Blood products and intravenous fluids are frequently used in the treatment of children who
      have undergone cardiac surgery in order to maintain hemodynamic stability. Optimal hematocrit
      values during CPB are still being discussed in children undergoing congenital cardiac
      surgery. The overall complication rate for transfusion in adults is 2.5 complications per
      1000 units, while 10.7 complications per 1000 transfusion in children. The aim of this study
      is to investigate the effects of the our transfusion strategies used in pediatric cardiac
      surgery on duration of intensive care unit, duration of postoperative mechanical ventilation
      and mortality.
Background: Blood products and intravenous fluids are frequently used in the treatment of
      children who have undergone cardiac surgery in order to maintain hemodynamic stability.
      Children undergoing cardiac surgery with cardiopulmonary bypass (CPB) are among the greatest
      pediatric users of allogeneic red blood cells (RBCs), and transfusions are used in 79% of all
      procedures. Optimal hematocrit values during CPB are still being discussed in children
      undergoing congenital cardiac surgery. While it is argued that high hematocrit values provide
      better results in perioperative period and postoperative neurological development, it is also
      argued that blood products are associated with mortality and morbidity. The overall
      complication rate for transfusion in adults is 2.5 complications per 1000 units, while 10.7
      complications per 1000 transfusion in children.

      Balancing the benefits and risks of blood transfusion is a particularly complex issue,
      especially in children. Because many aspects of transfusion therapy in children are not well
      researched.

      Method: This prospective, observational study will be conducted following Cukurova University
      Faculty of Medicine Ethics Committee approval. Children aged 16 years or younger who will
      undergo open heart surgery due to congenital heart disease will be included in the study.
      Patients with preoperative renal or hepatic disease will be excluded. Age, comorbidities,
      history of previous operation will be recorded. Preoperative hematocrit, biochemical
      parameters (blood urea nitrogen, creatinine, electrolytes), cardiac profile (angiography and
      echocardiography reports, diagnosis of the disease requiring the surgery) and preoperative
      medications, preoperative RACHS1 (risk adjustment for congenital heart disease, risk
      management for congenital heart disease) will be recorded.

      In the intraoperative period; the haematocrit values before CPB, during CPB, after CPB and
      after reversal of the heparin with protamine will be recorded. Aortic cross clamp time, body
      temperature, urine volume and diuretic use during CPB will be recorded. Blood gas values,
      central venous oxygen saturation (SvO2) and lactate levels will be recorded in the
      intraoperative period within 30 min intervals. The amount of crystalloid and colloid,
      erythrocyte, fresh frozen plasma, platelet and cryoprecipitate used in the intraoperative
      period will be recorded. The ACT (active coagulation time) values at the beginning and at the
      end of the operation, the amount of applied heparin and protamine will be recorded.
      Vasoactive agents (dopamine, dobutamine, adrenaline, nitroglycerin) used in the
      intraoperative period will be recorded.

      In the postoperative intensive care unit; blood gas and lactate values, hematocrit, chest
      tube drainage and iv fluids (crystalloid and colloid) and blood products will be recorded at
      postoperative 6th and 24th hours. The vasoactive agents, the inotrope score, the amount of
      urine and the use of diuretics will be recorded. The length of stay in intensive care unit,
      the duration of mechanical ventilation will be recorded.

      Major complications will be identified as cardiac arrest, neurological deficit (stroke,
      seizure), acute renal failure requiring dialysis therapy, arrhythmia requiring permanent
      heart pace and multiple organ dysfunction and recorded.
observational model: Cohort
time perspective: Prospective
measure: Length of stay in intensive care unit
time frame: Postoperative 3 months
description: Postoperative length of stay in intensive care unit
measure: Mortality
time frame: Postoperative 3 months
description: Postoperative mortality
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 16 Years
last name: Feri̇de Karacaer
role: Study Director
affiliation: Cukurova University
facility: 
country: Turkey
citation: Rizza A, Romagnoli S, Ricci Z. Fluid Status Assessment and Management During the Perioperative Phase in Pediatric Cardiac Surgery Patients. J Cardiothorac Vasc Anesth. 2016 Aug;30(4):1085-93. doi: 10.1053/j.jvca.2015.11.007. Epub 2015 Nov 10. No abstract available.
PMID: 26944520
responsible party type: Principal Investigator
investigator affiliation: Cukurova University
investigator full name: Feride Karacaer
investigator title: Specialist doctor
mesh term: Blood Loss, Surgical