<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/NCT04413721</url>
  </required_header>
  <id_info>
    <org_study_id>RBC20200505</org_study_id>
    <nct_id>NCT04413721</nct_id>
  </id_info>
  <brief_title>Effects of Packed Red Blood Cell Storage Duration on Pediatric Living Donor Liver Transplantation</brief_title>
  <official_title>Effects of Packed Red Blood Cell Storage Duration on Pediatric Living Donor Liver</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RenJi Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The patients assigned to either short-storage leukoreduced RBCs group (stored for ≤ 14 days)&#xD;
      or longer-term storage leukoreduced RBCs group(stored for ≥21 days).When the hemoglobin&#xD;
      concentration fell below 7.0 g per deciliter, PRBC were given to maintain the hemoglobin&#xD;
      concentrations in the range of 7.0 to 10.0/dL. The primary outcome : Death from all causes&#xD;
      in1-year after randomization. Secondary outcomes included: Intraoperative blood transfusion,&#xD;
      Postoperative blood transfusion, Postoperative inflammatory reaction, Mechanical ventilation&#xD;
      time in the intensive care unit, Lengths of stay in the intensive care unit and the hospital&#xD;
      were also recorded.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality in in1-year after randomization</measure>
    <time_frame>1-year after randomization.</time_frame>
    <description>Death from all causes in1-year after randomization.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Transfusion Related Complication</condition>
  <arm_group>
    <arm_group_label>Short-term storage RBCs (stored for ≤ 14 days)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients in this group were transfused with short-term storage RBCs (stored for ≤ 14 days).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Longer-term storage RBCs (stored for ≥21 days)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients in this group were transfused with longer-term storage RBCs (stored for ≥21 days).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>RBC transfustion</intervention_name>
    <description>When the hemoglobin concentration fell below 7.0 g per deciliter, RBC were given to maintain the hemoglobin concentrations in the range of 7.0 to 10.0g /dL</description>
    <arm_group_label>Longer-term storage RBCs (stored for ≥21 days)</arm_group_label>
    <arm_group_label>Short-term storage RBCs (stored for ≤ 14 days)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Our study included pediatric patients (6 months&lt; the moon's age &lt;36 months) who will&#xD;
             receive standard living-donor liver transplantation (LDLT) in Renji Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The exclu¬sion criteria of the study were a congenital sufferer from heart, lung,&#xD;
             kidney, nervous system or blood disease,active Lung infection，a history of liver&#xD;
             transplantation，Multivisceral transplantation , refused to participate the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>36 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 30, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 30, 2020</last_update_submitted>
  <last_update_submitted_qc>May 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>RenJi Hospital</investigator_affiliation>
    <investigator_full_name>Jie Tian</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <!-- 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/NCT04413721
org study id: RBC20200505
nct id: NCT04413721
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The patients assigned to either short-storage leukoreduced RBCs group (stored for ≤ 14 days)
      or longer-term storage leukoreduced RBCs group(stored for ≥21 days).When the hemoglobin
      concentration fell below 7.0 g per deciliter, PRBC were given to maintain the hemoglobin
      concentrations in the range of 7.0 to 10.0/dL. The primary outcome : Death from all causes
      in1-year after randomization. Secondary outcomes included: Intraoperative blood transfusion,
      Postoperative blood transfusion, Postoperative inflammatory reaction, Mechanical ventilation
      time in the intensive care unit, Lengths of stay in the intensive care unit and the hospital
      were also recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Mortality in in1-year after randomization
time frame: 1-year after randomization.
description: Death from all causes in1-year after randomization.
arm group label: Short-term storage RBCs (stored for ≤ 14 days)
arm group type: Experimental
description: patients in this group were transfused with short-term storage RBCs (stored for ≤ 14 days).
arm group label: Longer-term storage RBCs (stored for ≥21 days)
arm group type: Active Comparator
description: patients in this group were transfused with longer-term storage RBCs (stored for ≥21 days).
intervention type: Procedure
intervention name: RBC transfustion
description: When the hemoglobin concentration fell below 7.0 g per deciliter, RBC were given to maintain the hemoglobin concentrations in the range of 7.0 to 10.0g /dL
arm group label: Longer-term storage RBCs (stored for ≥21 days)
arm group label: Short-term storage RBCs (stored for ≤ 14 days)
criteria: 
gender: All
minimum age: 6 Months
maximum age: 36 Months
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: RenJi Hospital
investigator full name: Jie Tian
investigator title: Dr.