<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/NCT03814239</url>
  </required_header>
  <id_info>
    <org_study_id>papskoliosis</org_study_id>
    <nct_id>NCT03814239</nct_id>
  </id_info>
  <brief_title>Blood and Fluid Management During Scoliosis Surgery</brief_title>
  <official_title>Blood and Fluid Management During Scoliosis Surgery: A Single Center Retrospective Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>George Papanicolaou Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>George Papanicolaou Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In the present retrospective study, it was hypothesized that application, in scoliosis&#xD;
      surgery, of a protocol for blood and fluid management, based on goal directed fluid therapy,&#xD;
      cell salvage and tranexamic acid, could lead to reduced allogeneic red blood cells&#xD;
      transfusion. The patients will be enrolled in a retrospective observational study and divided&#xD;
      in two groups. Patients in no protocol Group received a liberal intraoperative fluid therapy&#xD;
      and patients in protocol Group received fluid therapy managed according to a stroke volume&#xD;
      variation based protocol. The protocol included fluid therapy according to SVV monitor,&#xD;
      permissive hypotension, tranexamic acid infusion, restrictive RBC trigger and use of&#xD;
      perioperative cell savage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At investigators institution, neither anesthetic approaches to replacement of blood or fluid&#xD;
      losses were standardized before 2014 for scoliosis surgery. Before 2014, fluid therapy was&#xD;
      liberal and according to general principles of good clinical practice and ephedrine boluses&#xD;
      of 5 mg were given when fluid boluses failed to maintain a systolic arterial pressure &gt;90 mm&#xD;
      Hg. Blood was replaced with crystalloid at a 3:1 ratio and colloid at a 1:1 ratio. Regarding&#xD;
      blood product transfusion anesthesiologists were generally initiated when hemoglobin levels&#xD;
      were less than 8 g/dl or less than 10 g/dl in patients with coronary diseases and predonated&#xD;
      autologous or allogeneic RBCs were administered.&#xD;
&#xD;
      A protocol of management for scoliosis surgery was implemented in 2014 and included: a) fluid&#xD;
      therapy according to SVV monitor, b) intraoperative permissive hypotension to reduce active&#xD;
      bleeding (goal mean arterial pressure 60 mmHg), c) prophylactic tranexamic acid infusion (30&#xD;
      mg/kg bolus, 1mg/kg/hr during surgery), d) restrictive RBC trigger according to national&#xD;
      standardized protocols (Hb&lt;7.0 g/dL or &lt;9g/dL in patients with coronary diseases) and e) use&#xD;
      of perioperative cell savage.&#xD;
&#xD;
      In patients of Group Pro, basal crystalloid infusion was started at 4 ml/kg/h right after&#xD;
      general anesthesia induction and intubation. ClearSight System (Edwards Lifesciences Cop,&#xD;
      Irvine, CA, USA) was used to measure stroke volume variation and cardiac output, continuously&#xD;
      and noninvasively through finger- cuffed technology. If SVV was &gt;15% rapid crystalloid bolus&#xD;
      of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%. After&#xD;
      two consecutive fluid boluses SVV remained &gt;15%, administration of noradrenaline infusion was&#xD;
      considered.&#xD;
&#xD;
      Data will be collected from anesthesia records and included: age, gender, height, weight,&#xD;
      body mass index and ASA score. Additional variables included infused crystalloid volume,&#xD;
      infused colloid volume and the number of allogeneic transfused units of RBC. Serum Hb levels&#xD;
      were measured preoperatively and after the end of surgery. Moreover, diuresis and use of&#xD;
      vasopressors use were recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2011</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 20, 2016</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>units of red blood cells transfused</measure>
    <time_frame>intraoperative</time_frame>
    <description>the overall units of red blood cells transfused during surgery. Hb&lt; 7 was the trigger for transfusion in protocol group and Hb&lt;8 for no transfusion group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>volume of crystalloids infused</measure>
    <time_frame>intraoperative</time_frame>
    <description>the overall volume of crystalloids infused during surgery. In patients of Group Pro, basal crystalloid infusion was started at 4 ml/kg/h If SVV was &gt;15% rapid crystalloid bolus of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>volume of colloids infused</measure>
    <time_frame>intraoperative</time_frame>
    <description>the overall volume of colloid infused during surgery. In patients of Group Pro, basal crystalloid infusion was started at 4 ml/kg/h. If SVV was &gt;15% rapid crystalloid bolus of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>infused vasopressors</measure>
    <time_frame>intraoperative</time_frame>
    <description>The decision to use ephedrine or noradrenaline. In patients of Group Pro if after two consecutive fluid boluses SVV remained &gt;15%, administration of noradrenaline or ephedrine was considered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diuresis</measure>
    <time_frame>intraoperative</time_frame>
    <description>volume of urine production during surgery.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">35</enrollment>
  <condition>Scoliosis</condition>
  <arm_group>
    <arm_group_label>no protocol</arm_group_label>
    <description>liberal fluid therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>protocol</arm_group_label>
    <description>fluid therapy according to stroke volume variation (SVV) monitor, tranexamic acid administration, use of cell saver</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>protocol</intervention_name>
    <description>In patients of Group Protocol , basal crystalloid infusion was started at 4 ml/kg/h right after general anesthesia induction and intubation. ClearSight System (Edwards Lifesciences Cop, Irvine, CA, USA) was used to measure stroke volume variation and cardiac output, continuously and noninvasively through finger- cuffed technology. If SVV was &gt;15% rapid crystalloid bolus of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%. After two consecutive fluid boluses SVV remained &gt;15%, administration of noradrenaline infusion was considered.</description>
    <arm_group_label>protocol</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for elective orthopaedic surgery of scoliosis, with a planned intensive&#xD;
        care unit admission, were enrolled in a retrospective observational study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. severe curve (Cobb Angle &gt; 70-degree)&#xD;
&#xD;
          2. same surgeon in all procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with coagulopathy,&#xD;
&#xD;
          2. morbid obesity&#xD;
&#xD;
          3. severe cardiopulmonary disease&#xD;
&#xD;
          4. liver dysfunction&#xD;
&#xD;
          5. renal disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anastasia Trikoupi</last_name>
    <role>Study Chair</role>
    <affiliation>Director of Anesthesiology Department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>George Papanikoalou Hospital</name>
      <address>
        <city>Thessaloníki</city>
        <zip>57010</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>George Papanicolaou Hospital</investigator_affiliation>
    <investigator_full_name>Stachtari Chrysoula MD, PhD</investigator_full_name>
    <investigator_title>Stachtari Chrysoula, Consultant Anesthesiologist, G. Papanikolaou hospital</investigator_title>
  </responsible_party>
  <keyword>transfusion</keyword>
  <keyword>goal directed fluid therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03814239
org study id: papskoliosis
nct id: NCT03814239
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In the present retrospective study, it was hypothesized that application, in scoliosis
      surgery, of a protocol for blood and fluid management, based on goal directed fluid therapy,
      cell salvage and tranexamic acid, could lead to reduced allogeneic red blood cells
      transfusion. The patients will be enrolled in a retrospective observational study and divided
      in two groups. Patients in no protocol Group received a liberal intraoperative fluid therapy
      and patients in protocol Group received fluid therapy managed according to a stroke volume
      variation based protocol. The protocol included fluid therapy according to SVV monitor,
      permissive hypotension, tranexamic acid infusion, restrictive RBC trigger and use of
      perioperative cell savage.
At investigators institution, neither anesthetic approaches to replacement of blood or fluid
      losses were standardized before 2014 for scoliosis surgery. Before 2014, fluid therapy was
      liberal and according to general principles of good clinical practice and ephedrine boluses
      of 5 mg were given when fluid boluses failed to maintain a systolic arterial pressure >90 mm
      Hg. Blood was replaced with crystalloid at a 3:1 ratio and colloid at a 1:1 ratio. Regarding
      blood product transfusion anesthesiologists were generally initiated when hemoglobin levels
      were less than 8 g/dl or less than 10 g/dl in patients with coronary diseases and predonated
      autologous or allogeneic RBCs were administered.

      A protocol of management for scoliosis surgery was implemented in 2014 and included: a) fluid
      therapy according to SVV monitor, b) intraoperative permissive hypotension to reduce active
      bleeding (goal mean arterial pressure 60 mmHg), c) prophylactic tranexamic acid infusion (30
      mg/kg bolus, 1mg/kg/hr during surgery), d) restrictive RBC trigger according to national
      standardized protocols (Hb<7.0 g/dL or <9g/dL in patients with coronary diseases) and e) use
      of perioperative cell savage.

      In patients of Group Pro, basal crystalloid infusion was started at 4 ml/kg/h right after
      general anesthesia induction and intubation. ClearSight System (Edwards Lifesciences Cop,
      Irvine, CA, USA) was used to measure stroke volume variation and cardiac output, continuously
      and noninvasively through finger- cuffed technology. If SVV was >15% rapid crystalloid bolus
      of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%. After
      two consecutive fluid boluses SVV remained >15%, administration of noradrenaline infusion was
      considered.

      Data will be collected from anesthesia records and included: age, gender, height, weight,
      body mass index and ASA score. Additional variables included infused crystalloid volume,
      infused colloid volume and the number of allogeneic transfused units of RBC. Serum Hb levels
      were measured preoperatively and after the end of surgery. Moreover, diuresis and use of
      vasopressors use were recorded.
observational model: Cohort
time perspective: Retrospective
measure: units of red blood cells transfused
time frame: intraoperative
description: the overall units of red blood cells transfused during surgery. Hb< 7 was the trigger for transfusion in protocol group and Hb<8 for no transfusion group.
measure: volume of crystalloids infused
time frame: intraoperative
description: the overall volume of crystalloids infused during surgery. In patients of Group Pro, basal crystalloid infusion was started at 4 ml/kg/h If SVV was >15% rapid crystalloid bolus of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%.
measure: volume of colloids infused
time frame: intraoperative
description: the overall volume of colloid infused during surgery. In patients of Group Pro, basal crystalloid infusion was started at 4 ml/kg/h. If SVV was >15% rapid crystalloid bolus of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%.
measure: infused vasopressors
time frame: intraoperative
description: The decision to use ephedrine or noradrenaline. In patients of Group Pro if after two consecutive fluid boluses SVV remained >15%, administration of noradrenaline or ephedrine was considered.
measure: diuresis
time frame: intraoperative
description: volume of urine production during surgery.
arm group label: no protocol
description: liberal fluid therapy
arm group label: protocol
description: fluid therapy according to stroke volume variation (SVV) monitor, tranexamic acid administration, use of cell saver
intervention type: Other
intervention name: protocol
description: In patients of Group Protocol , basal crystalloid infusion was started at 4 ml/kg/h right after general anesthesia induction and intubation. ClearSight System (Edwards Lifesciences Cop, Irvine, CA, USA) was used to measure stroke volume variation and cardiac output, continuously and noninvasively through finger- cuffed technology. If SVV was >15% rapid crystalloid bolus of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%. After two consecutive fluid boluses SVV remained >15%, administration of noradrenaline infusion was considered.
arm group label: protocol
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Anastasia Trikoupi
role: Study Chair
affiliation: Director of Anesthesiology Department
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: George Papanicolaou Hospital
investigator full name: Stachtari Chrysoula MD, PhD
investigator title: Stachtari Chrysoula, Consultant Anesthesiologist, G. Papanikolaou hospital
mesh term: Scoliosis
sharing ipd: Undecided