<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/NCT04471688</url>
  </required_header>
  <id_info>
    <org_study_id>ThirdXiangyaMSID</org_study_id>
    <nct_id>NCT04471688</nct_id>
  </id_info>
  <brief_title>Multicenter Study on Detection Strategy of Infectious Diseases in Blood Transfusion</brief_title>
  <official_title>Multicenter Study on Detection Strategy of Infectious Diseases in Blood Transfusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Third Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SANSURE BIOTECH INC.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Third Xiangya Hospital of Central South University</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>
      In the past ten years, nucleic acid detection technology has overcome the limitations of&#xD;
      serological detection, reduced missed detections due to window period, occult infection,&#xD;
      etc., and its application in the field of pathogen detection has developed rapidly. Since&#xD;
      2015, domestic blood collection and supply institutions have fully popularized nucleic acid&#xD;
      testing. The safety screening of blood sources mostly adopts the method of combining two&#xD;
      times of enzyme-free negative and one time of nucleic acid testing, which excludes the&#xD;
      guarantee of blood safety to the greatest extent.&#xD;
&#xD;
      At present, the clinical pre-transfusion and pre-operative infectious disease screening in&#xD;
      our country is still serological detection. The use of nucleic acid detection for infectious&#xD;
      disease screening can better realize the significance of patients'&#xD;
      pre-transfusion/pre-operative infectious disease screening. Therefore, this study will&#xD;
      analyze the nucleic acid detection technology and clinical serological detection technology&#xD;
      in order to solve three problems:&#xD;
&#xD;
        -  Explore the best detection strategy for patients with pre-transfusion/pre-operative&#xD;
           infectious disease screening; ② Explore the confirmation process of the gray area&#xD;
           results of infectious disease serological testing; ③ Better realize the significance of&#xD;
           screening for patients' infectious diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hepatitis B Infection Analysis result</measure>
    <time_frame>20190601-20201231</time_frame>
    <description>Nucleic acid examination and serological test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hepatitis C Infection Analysis result</measure>
    <time_frame>20190601-20201231</time_frame>
    <description>Nucleic acid examination and serological test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HIV Infection Analysis result</measure>
    <time_frame>20190601-20201231</time_frame>
    <description>Nucleic acid examination and serological test</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Infectious Disease Screening</condition>
  <arm_group>
    <arm_group_label>patients</arm_group_label>
    <description>Preoperative patients needing transfusions</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>infectious disease screening</intervention_name>
    <description>Explore the best detection strategy for patients with pre-transfusion/pre-operative infectious disease screening</description>
    <arm_group_label>patients</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The sera of the recruited participants&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This study plans to test 10,000 clinical specimens&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hosipital patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <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>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nucleic acid</keyword>
  <keyword>pre-transfusion</keyword>
  <keyword>pre-operative</keyword>
  <keyword>pathogen detection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04471688
org study id: ThirdXiangyaMSID
nct id: NCT04471688
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
In the past ten years, nucleic acid detection technology has overcome the limitations of
      serological detection, reduced missed detections due to window period, occult infection,
      etc., and its application in the field of pathogen detection has developed rapidly. Since
      2015, domestic blood collection and supply institutions have fully popularized nucleic acid
      testing. The safety screening of blood sources mostly adopts the method of combining two
      times of enzyme-free negative and one time of nucleic acid testing, which excludes the
      guarantee of blood safety to the greatest extent.

      At present, the clinical pre-transfusion and pre-operative infectious disease screening in
      our country is still serological detection. The use of nucleic acid detection for infectious
      disease screening can better realize the significance of patients'
      pre-transfusion/pre-operative infectious disease screening. Therefore, this study will
      analyze the nucleic acid detection technology and clinical serological detection technology
      in order to solve three problems:

        -  Explore the best detection strategy for patients with pre-transfusion/pre-operative
           infectious disease screening; ② Explore the confirmation process of the gray area
           results of infectious disease serological testing; ③ Better realize the significance of
           screening for patients' infectious diseases.
observational model: Other
time perspective: Prospective
measure: Hepatitis B Infection Analysis result
time frame: 20190601-20201231
description: Nucleic acid examination and serological test
measure: Hepatitis C Infection Analysis result
time frame: 20190601-20201231
description: Nucleic acid examination and serological test
measure: HIV Infection Analysis result
time frame: 20190601-20201231
description: Nucleic acid examination and serological test
arm group label: patients
description: Preoperative patients needing transfusions
intervention type: Diagnostic Test
intervention name: infectious disease screening
description: Explore the best detection strategy for patients with pre-transfusion/pre-operative infectious disease screening
arm group label: patients
The sera of the recruited participants
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections
sharing ipd: No