<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/NCT03814772</url>
  </required_header>
  <id_info>
    <org_study_id>ThirdXiangyaLTP</org_study_id>
    <nct_id>NCT03814772</nct_id>
  </id_info>
  <brief_title>To Establish a Blood Transfusion Prediction Model for Liver Transplantation Patients Based on PBM</brief_title>
  <official_title>To Establish a Prediction Model of Massive Blood Transfusion for Liver Transplantation Patients Based on Patient Blood Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Third Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Second Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qilu Hospital of Shandong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Third Xiangya Hospital of Central South 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>
      Based on the principle of patient blood management, this study aims to reduce the risk of&#xD;
      blood transfusion in allogeneic liver transplantation patients, to ensure the safety of blood&#xD;
      transfusion, and to provide new methods and basis for restrictive blood transfusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Preoperative variables and statistical analysis of a large number of intraoperative&#xD;
           blood transfusions in allogeneic liver transplantation patients were performed to screen&#xD;
           preoperative variables.&#xD;
&#xD;
        2. Models were established by machine learning algorithms to predict a large number of&#xD;
           blood transfusions during surgery, providing a reference for preoperative blood&#xD;
           preparation and postoperative outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">March 20, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>one year mortality</measure>
    <time_frame>2019-2021</time_frame>
    <description>All-cause mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraoperative blood transfusion</measure>
    <time_frame>2019-2021</time_frame>
    <description>Intraoperative blood component input</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Blood Transfusion Complication</condition>
  <arm_group>
    <arm_group_label>Liver transplant</arm_group_label>
    <description>18 years to 65&#xD;
48h preoperative biochemical indicators, blood general indicators, coagulation test complete</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Liver transplant</intervention_name>
    <description>blood transfusion</description>
    <arm_group_label>Liver transplant</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Allogeneic liver transplantation surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  48h preoperative biochemical indicators, blood general indicators, coagulation test&#xD;
             complete&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Inspection information is not detailed 2. Blood transfusion information is not&#xD;
             detailed 3.Postoperative medical record information is not detailed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Rong Gui, doctor</last_name>
    <phone>+8615200828442</phone>
    <email>aguirong@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>the Third Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rong Gui</last_name>
      <phone>+8615200828442</phone>
      <email>aguirong@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>liver transplantation</keyword>
  <keyword>blood transfusion</keyword>
  <keyword>Patient blood management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Transfusion Reaction</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/NCT03814772
org study id: ThirdXiangyaLTP
nct id: NCT03814772
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Based on the principle of patient blood management, this study aims to reduce the risk of
      blood transfusion in allogeneic liver transplantation patients, to ensure the safety of blood
      transfusion, and to provide new methods and basis for restrictive blood transfusion.
1. Preoperative variables and statistical analysis of a large number of intraoperative
           blood transfusions in allogeneic liver transplantation patients were performed to screen
           preoperative variables.

        2. Models were established by machine learning algorithms to predict a large number of
           blood transfusions during surgery, providing a reference for preoperative blood
           preparation and postoperative outcome.
observational model: Cohort
time perspective: Cross-Sectional
measure: one year mortality
time frame: 2019-2021
description: All-cause mortality
measure: Intraoperative blood transfusion
time frame: 2019-2021
description: Intraoperative blood component input
arm group label: Liver transplant
description: 18 years to 65
48h preoperative biochemical indicators, blood general indicators, coagulation test complete
intervention type: Procedure
intervention name: Liver transplant
description: blood transfusion
arm group label: Liver transplant
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
last name: Rong Gui, doctor
phone: +8615200828442
email: aguirong@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Transfusion Reaction
sharing ipd: Undecided