<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/NCT02263157</url>
  </required_header>
  <id_info>
    <org_study_id>BSI-PLT</org_study_id>
    <nct_id>NCT02263157</nct_id>
  </id_info>
  <brief_title>Evaluate the Association Between Infection and Thrombocytopenia</brief_title>
  <official_title>Evaluate the Association Between Blood Stream Infection (BSI) and Thrombocytopenia (Surgical Intensive Care Unit)SICU Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jinling Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jinling Hospital, China</source>
  <brief_summary>
    <textblock>
      The study is designed to evaluate the association between nosocomial bloodstream infection&#xD;
      and the occurrence of thrombocytopenia in surgical critical ill patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>mortality rate</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">390</enrollment>
  <condition>Thrombocytopenia</condition>
  <arm_group>
    <arm_group_label>BSI group with thrombocytopenia</arm_group_label>
    <description>BSI patients with thrombocytopenia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-BSI group with thrombocytopenia</arm_group_label>
    <description>Non-BSI patients with thrombocytopenia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BSI group without thrombocytopenia</arm_group_label>
    <description>BSI patients without thrombocytopenia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-BSI group without thrombocytopenia</arm_group_label>
    <description>Non-BSI patients without thrombocytopenia</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Sequential consenting adult patients of either sex were prospectively enrolled into the&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sequential consenting adult patients of either sex were prospectively enrolled into&#xD;
             the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who passed away within 24 hours after hospitalization would be excluded.&#xD;
&#xD;
        Patients who developed into a bloodstream infection within 48 hours after hospital&#xD;
        admission were also excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 5, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 8, 2014</last_update_submitted>
  <last_update_submitted_qc>October 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jinling Hospital, China</investigator_affiliation>
    <investigator_full_name>Jianan Ren</investigator_full_name>
    <investigator_title>BSI-PLT</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombocytopenia</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/NCT02263157
org study id: BSI-PLT
nct id: NCT02263157
lead sponsor: 
The study is designed to evaluate the association between nosocomial bloodstream infection
      and the occurrence of thrombocytopenia in surgical critical ill patients.
observational model: Case-Control
time perspective: Prospective
measure: mortality rate
time frame: 28 days
arm group label: BSI group with thrombocytopenia
description: BSI patients with thrombocytopenia
arm group label: Non-BSI group with thrombocytopenia
description: Non-BSI patients with thrombocytopenia
arm group label: BSI group without thrombocytopenia
description: BSI patients without thrombocytopenia
arm group label: Non-BSI group without thrombocytopenia
description: Non-BSI patients without thrombocytopenia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Jinling Hospital, China
investigator full name: Jianan Ren
investigator title: BSI-PLT
mesh term: Thrombocytopenia