<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/NCT03756948</url>
  </required_header>
  <id_info>
    <org_study_id>VETLT</org_study_id>
    <nct_id>NCT03756948</nct_id>
  </id_info>
  <brief_title>Viscoelastic Tests-Guided Therapy In Liver Transplantation</brief_title>
  <acronym>VETLT</acronym>
  <official_title>Association Between Viscoelastic Tests-Guided Therapy With Synthetic Factor Concentrates And Allogenic Blood Transfusion In Liver Transplantation: A Before-After Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Israelita Albert Einstein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Israelita Albert Einstein</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      BACKGROUND: Perioperative bleeding and transfusion are important causes of morbidity and&#xD;
      mortality in patients undergoing liver transplantation. The aim of this study is to assess&#xD;
      whether viscoelastic tests-guided therapy with the use of synthetic factor concentrates&#xD;
      impact transfusion rates of hemocomponents in adult patients undergoing liver&#xD;
      transplantation.&#xD;
&#xD;
      METHODS: This is an interventional before-after comparative study. Patients undergoing liver&#xD;
      transplantation before the implementation of a protocol using thromboelastometry and&#xD;
      synthetic factor concentrates were compared to patients after the implementation. Primary&#xD;
      outcome was transfusion of any hemocomponents. Secondary outcomes included: transfusion of&#xD;
      red blood cells (RBC), fresh frozen plasma (FFP), cryoprecipitate or platelets, clinical&#xD;
      complications, length of stay and in-hospital mortality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2007</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 30, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Need of Any Blood Products Transfusion</measure>
    <time_frame>48 Hours</time_frame>
    <description>Collapsed composite of need of any transfusion of blood product during surgery and in the first 48 hours in the postoperative, including the need of RBC, FFP, cryoprecipitate and/or platelets.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Use of Synthetic Factor Concentrates or Antifibrinolytic</measure>
    <time_frame>48 Hours</time_frame>
    <description>Any use of synthetic factor concentrates or antifibrinolytic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Complications Related to the Procedure</measure>
    <time_frame>Third days or until hospital discharge, whichever occurs first</time_frame>
    <description>Defined as: 1) Upper digestive hemorrhage; 2) Arterial thrombosis; 3) Infection; and/or 4) Any thromboembolic event</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Mechanical Ventilation</measure>
    <time_frame>Third days or until hospital discharge, whichever occurs first</time_frame>
    <description>Duration of mechanical ventilation in the post-operative period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU Length of Stay</measure>
    <time_frame>Third days or until ICU discharge, whichever occurs first</time_frame>
    <description>Duration of stay in the intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>Third days or until hospital discharge, whichever occurs first</time_frame>
    <description>Duration of stay in the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-Hospital Mortality</measure>
    <time_frame>Third days or until hospital discharge, whichever occurs first</time_frame>
    <description>Any death during hospitalization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">237</enrollment>
  <condition>Liver Transplant; Complications</condition>
  <condition>Bleeding</condition>
  <condition>Hemostatic Disorder</condition>
  <arm_group>
    <arm_group_label>Usual Care (Before)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>No Thromboelastometry No Synthetic Factor Concentrates Usual Care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Thromboelastometry-Guided Therapy (After)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components</description>
    <arm_group_label>Usual Care (Before)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates</intervention_name>
    <description>Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates</description>
    <arm_group_label>Thromboelastometry-Guided Therapy (After)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Deceased Donor Liver Transplantation&#xD;
&#xD;
          -  Chronic Liver Disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute Liver Failure&#xD;
&#xD;
          -  Combined Transplantation&#xD;
&#xD;
          -  Re-Transplantation is Less Than 30 Days After the First Transplant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ary Serpa Neto, MD, MSc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physician and Researcher</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Raffael PC Zamper, MD</last_name>
    <role>Study Director</role>
    <affiliation>Raffael</affiliation>
  </overall_official>
  <reference>
    <citation>Rana A, Petrowsky H, Hong JC, Agopian VG, Kaldas FM, Farmer D, Yersiz H, Hiatt JR, Busuttil RW. Blood transfusion requirement during liver transplantation is an important risk factor for mortality. J Am Coll Surg. 2013 May;216(5):902-7. doi: 10.1016/j.jamcollsurg.2012.12.047. Epub 2013 Mar 9.</citation>
    <PMID>23478547</PMID>
  </reference>
  <reference>
    <citation>Hartmann M, Szalai C, Saner FH. Hemostasis in liver transplantation: Pathophysiology, monitoring, and treatment. World J Gastroenterol. 2016 Jan 28;22(4):1541-50. doi: 10.3748/wjg.v22.i4.1541.</citation>
    <PMID>26819521</PMID>
  </reference>
  <reference>
    <citation>Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x.</citation>
    <PMID>15784122</PMID>
  </reference>
  <reference>
    <citation>Weber CF, Gorlinger K, Meininger D, Herrmann E, Bingold T, Moritz A, Cohn LH, Zacharowski K. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology. 2012 Sep;117(3):531-47. doi: 10.1097/ALN.0b013e318264c644.</citation>
    <PMID>22914710</PMID>
  </reference>
  <reference>
    <citation>Wang SC, Shieh JF, Chang KY, Chu YC, Liu CS, Loong CC, Chan KH, Mandell S, Tsou MY. Thromboelastography-guided transfusion decreases intraoperative blood transfusion during orthotopic liver transplantation: randomized clinical trial. Transplant Proc. 2010 Sep;42(7):2590-3. doi: 10.1016/j.transproceed.2010.05.144.</citation>
    <PMID>20832550</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 27, 2018</last_update_submitted>
  <last_update_submitted_qc>November 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Liver Transplantation</keyword>
  <keyword>Blood Coagulation Disorders</keyword>
  <keyword>Blood Transfusion</keyword>
  <keyword>Hemostasis</keyword>
  <keyword>Thromboelastometry</keyword>
  <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>
  </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/NCT03756948
org study id: VETLT
nct id: NCT03756948
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
BACKGROUND: Perioperative bleeding and transfusion are important causes of morbidity and
      mortality in patients undergoing liver transplantation. The aim of this study is to assess
      whether viscoelastic tests-guided therapy with the use of synthetic factor concentrates
      impact transfusion rates of hemocomponents in adult patients undergoing liver
      transplantation.

      METHODS: This is an interventional before-after comparative study. Patients undergoing liver
      transplantation before the implementation of a protocol using thromboelastometry and
      synthetic factor concentrates were compared to patients after the implementation. Primary
      outcome was transfusion of any hemocomponents. Secondary outcomes included: transfusion of
      red blood cells (RBC), fresh frozen plasma (FFP), cryoprecipitate or platelets, clinical
      complications, length of stay and in-hospital mortality.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Need of Any Blood Products Transfusion
time frame: 48 Hours
description: Collapsed composite of need of any transfusion of blood product during surgery and in the first 48 hours in the postoperative, including the need of RBC, FFP, cryoprecipitate and/or platelets.
measure: Use of Synthetic Factor Concentrates or Antifibrinolytic
time frame: 48 Hours
description: Any use of synthetic factor concentrates or antifibrinolytic
measure: Clinical Complications Related to the Procedure
time frame: Third days or until hospital discharge, whichever occurs first
description: Defined as: 1) Upper digestive hemorrhage; 2) Arterial thrombosis; 3) Infection; and/or 4) Any thromboembolic event
measure: Duration of Mechanical Ventilation
time frame: Third days or until hospital discharge, whichever occurs first
description: Duration of mechanical ventilation in the post-operative period
measure: ICU Length of Stay
time frame: Third days or until ICU discharge, whichever occurs first
description: Duration of stay in the intensive care unit
measure: Hospital Length of Stay
time frame: Third days or until hospital discharge, whichever occurs first
description: Duration of stay in the hospital
measure: In-Hospital Mortality
time frame: Third days or until hospital discharge, whichever occurs first
description: Any death during hospitalization
arm group label: Usual Care (Before)
arm group type: Active Comparator
description: No Thromboelastometry No Synthetic Factor Concentrates Usual Care
arm group label: Thromboelastometry-Guided Therapy (After)
arm group type: Experimental
description: Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates
intervention type: Other
intervention name: Usual Care
description: Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components
arm group label: Usual Care (Before)
intervention type: Other
intervention name: Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates
description: Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates
arm group label: Thromboelastometry-Guided Therapy (After)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ary Serpa Neto, MD, MSc, PhD
role: Principal Investigator
affiliation: Physician and Researcher
last name: Raffael PC Zamper, MD
role: Study Director
affiliation: Raffael
citation: Rana A, Petrowsky H, Hong JC, Agopian VG, Kaldas FM, Farmer D, Yersiz H, Hiatt JR, Busuttil RW. Blood transfusion requirement during liver transplantation is an important risk factor for mortality. J Am Coll Surg. 2013 May;216(5):902-7. doi: 10.1016/j.jamcollsurg.2012.12.047. Epub 2013 Mar 9.
PMID: 23478547
citation: Hartmann M, Szalai C, Saner FH. Hemostasis in liver transplantation: Pathophysiology, monitoring, and treatment. World J Gastroenterol. 2016 Jan 28;22(4):1541-50. doi: 10.3748/wjg.v22.i4.1541.
PMID: 26819521
citation: Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x.
PMID: 15784122
citation: Weber CF, Gorlinger K, Meininger D, Herrmann E, Bingold T, Moritz A, Cohn LH, Zacharowski K. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology. 2012 Sep;117(3):531-47. doi: 10.1097/ALN.0b013e318264c644.
PMID: 22914710
citation: Wang SC, Shieh JF, Chang KY, Chu YC, Liu CS, Loong CC, Chan KH, Mandell S, Tsou MY. Thromboelastography-guided transfusion decreases intraoperative blood transfusion during orthotopic liver transplantation: randomized clinical trial. Transplant Proc. 2010 Sep;42(7):2590-3. doi: 10.1016/j.transproceed.2010.05.144.
PMID: 20832550
responsible party type: Sponsor
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
sharing ipd: Undecided