<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/NCT02967328</url>
  </required_header>
  <id_info>
    <org_study_id>ITP-Reticulated Platelets</org_study_id>
    <nct_id>NCT02967328</nct_id>
  </id_info>
  <brief_title>RP% Measurement by FCM as a Diagnostic Test for ITP</brief_title>
  <official_title>A Multi-Center Prospective Blind Study of RP% Measurement by Flow Cytometry in the Diagnosis of Primary Immune Thrombocytopenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jinan Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qianfoshan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shandong University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Immature platelets-also termed reticulated platelets (RP)-are platelets newly released into&#xD;
      the circulation, and have been associated with a variety of pathological bleeding events&#xD;
      including primary immune thrombocytopenia (ITP). They can be assessed by flow cytometry (FCM)&#xD;
      after staining with thiazole orange (TO) at low concentration and expressed as a fraction of&#xD;
      the total platelet count (RP%). The diagnosis of primary ITP is based on differential&#xD;
      diagnosis and the measurement of RP% can serve as an alternative diagnostic test that are&#xD;
      useful in daily practice. Our study aimed at distinguishing primary ITP from other&#xD;
      thrombocytopenic disorders, especially aplstic (hypoplastic) or chemotherapy-induced&#xD;
      thrombocytopenia by FCM. The sensitivity and specificity of the assay as well as agreement&#xD;
      between RP% measurement and monoclonal antibody-specific immobilization of platelet antigen&#xD;
      (MAIPA) were analyzed accordingly.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are undertaking a multi-center, prospective blind trial of 500 adults with&#xD;
      thrombocytopenic disorders with a platelet count less than 60*10^9/L from 4 medical centers&#xD;
      in China. In brief, 15 μl aliquots of anti-coagulated whole blood were incubated for 70 min&#xD;
      with 5 μl of phycoerythrin-conjugated anti-CD42b monoclonal antibody (BD Pharmingen, Tokyo,&#xD;
      Japan) and 1 ml of thiazole orange (Retic-COUNT; Becton-Dickinson, San Jose, CA, USA) diluted&#xD;
      10 times by phosphate-buffered saline. RP% was analyzed on a flow cytometer (FACScan,&#xD;
      Becton-Dickinson) by measuring 10,000 events in the CD42b-positive fraction.&#xD;
&#xD;
      Clinical information of all participants including gender, age, platelet count and definitive&#xD;
      diagnosis were recorded by an exclusive investigator. RP% results were revealed at the end of&#xD;
      recruitment and after all FCM measurements were completed. The agreement between clinical&#xD;
      diagnosis and RP% results were analyzed to identify primary ITP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Total platelet count (RP%)</measure>
    <time_frame>The day upon enrollment</time_frame>
    <description>We defined an upper limit for healthy control subjects as mean + 3SD in this study.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Immune Thrombocytopenia</condition>
  <arm_group>
    <arm_group_label>RP% Measurement by FCM as a Diagnostic Test for ITP</arm_group_label>
    <description>The investigators are undertaking a multi-center, prospective blind trial of 500 adults with thrombocytopenic disorders with a platelet count less than 60000/uL from 4 medical centers in China. In brief, 15 ul aliquots of anti-coagulated whole blood were incubated for 70 min with 5 ul of phycoerythrin-conjugated anti-CD42b monoclonal antibody (BD Pharmingen, Tokyo, Japan) and 1 ml of thiazole orange (Retic-COUNT; Becton-Dickinson, San Jose, CA, USA) diluted 10 times by phosphate-buffered saline. RP% was analyzed on a flow cytometer (FACScan, Becton-Dickinson) by measuring 10,000 events in the CD42b-positive fraction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>RP% Measurement by FCM as a Diagnostic Test for ITP</intervention_name>
    <arm_group_label>RP% Measurement by FCM as a Diagnostic Test for ITP</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        500 adults with thrombocytopenic disorders with a platelet count less than 60000/uL from 4&#xD;
        medical centers in China.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Untreated adult patients of both gender between the ages of 18 and 75 years&#xD;
&#xD;
          2. Each participant showed a platelet count 60*10^9/L, with or without bleeding&#xD;
             manifestations&#xD;
&#xD;
          3. Thrombocytopenic disorders including autoimmune-mediated, aplastic (hypoplastic) or&#xD;
             chemotherapy-induced thrombocytopenia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Received high-dose steroids or IVIG within 3 weeks prior to the test&#xD;
&#xD;
          2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine,&#xD;
             vincristine, vinblastine, etc) within 3 months prior to the test&#xD;
&#xD;
          3. Current HIV infection, hepatitis B virus or hepatitis C virus infections&#xD;
&#xD;
          4. Severe medical condition (liver and kidney function impairment). Unstable&#xD;
             cardiovascular disease or uncontrolled hypertension.&#xD;
&#xD;
          5. Patients who are deemed unsuitable for the study by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Qilu Hospital, Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ming Hou, Dr.</last_name>
      <phone>+86-531-82169114</phone>
      <phone_ext>9879</phone_ext>
      <email>houming@medmail.com.cn</email>
    </contact>
    <investigator>
      <last_name>Ming Hou, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Sakuragi M, Hayashi S, Maruyama M, Kabutomori O, Kiyokawa T, Nagamine K, Kato H, Kashiwagi H, Kanakura Y, Tomiyama Y. Clinical significance of IPF% or RP% measurement in distinguishing primary immune thrombocytopenia from aplastic thrombocytopenic disorders. Int J Hematol. 2015 Apr;101(4):369-75. doi: 10.1007/s12185-015-1741-0. Epub 2015 Jan 25.</citation>
    <PMID>25618218</PMID>
  </results_reference>
  <results_reference>
    <citation>Ibrahim H, Nadipalli S, Usmani S, DeLao T, Green L, Kleiman NS. Detection and quantification of circulating immature platelets: agreement between flow cytometric and automated detection. J Thromb Thrombolysis. 2016 Jul;42(1):77-83. doi: 10.1007/s11239-016-1338-3.</citation>
    <PMID>26831482</PMID>
  </results_reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 17, 2016</last_update_submitted>
  <last_update_submitted_qc>November 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Ming Hou</investigator_full_name>
    <investigator_title>Professor and Director</investigator_title>
  </responsible_party>
  <keyword>Reticulated Platelets</keyword>
  <keyword>Immune Thrombocytopenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombocytopenia</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic, Idiopathic</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/NCT02967328
org study id: ITP-Reticulated Platelets
nct id: NCT02967328
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Immature platelets-also termed reticulated platelets (RP)-are platelets newly released into
      the circulation, and have been associated with a variety of pathological bleeding events
      including primary immune thrombocytopenia (ITP). They can be assessed by flow cytometry (FCM)
      after staining with thiazole orange (TO) at low concentration and expressed as a fraction of
      the total platelet count (RP%). The diagnosis of primary ITP is based on differential
      diagnosis and the measurement of RP% can serve as an alternative diagnostic test that are
      useful in daily practice. Our study aimed at distinguishing primary ITP from other
      thrombocytopenic disorders, especially aplstic (hypoplastic) or chemotherapy-induced
      thrombocytopenia by FCM. The sensitivity and specificity of the assay as well as agreement
      between RP% measurement and monoclonal antibody-specific immobilization of platelet antigen
      (MAIPA) were analyzed accordingly.
The investigators are undertaking a multi-center, prospective blind trial of 500 adults with
      thrombocytopenic disorders with a platelet count less than 60*10^9/L from 4 medical centers
      in China. In brief, 15 μl aliquots of anti-coagulated whole blood were incubated for 70 min
      with 5 μl of phycoerythrin-conjugated anti-CD42b monoclonal antibody (BD Pharmingen, Tokyo,
      Japan) and 1 ml of thiazole orange (Retic-COUNT; Becton-Dickinson, San Jose, CA, USA) diluted
      10 times by phosphate-buffered saline. RP% was analyzed on a flow cytometer (FACScan,
      Becton-Dickinson) by measuring 10,000 events in the CD42b-positive fraction.

      Clinical information of all participants including gender, age, platelet count and definitive
      diagnosis were recorded by an exclusive investigator. RP% results were revealed at the end of
      recruitment and after all FCM measurements were completed. The agreement between clinical
      diagnosis and RP% results were analyzed to identify primary ITP.
observational model: Case-Only
time perspective: Prospective
measure: Total platelet count (RP%)
time frame: The day upon enrollment
description: We defined an upper limit for healthy control subjects as mean + 3SD in this study.
arm group label: RP% Measurement by FCM as a Diagnostic Test for ITP
description: The investigators are undertaking a multi-center, prospective blind trial of 500 adults with thrombocytopenic disorders with a platelet count less than 60000/uL from 4 medical centers in China. In brief, 15 ul aliquots of anti-coagulated whole blood were incubated for 70 min with 5 ul of phycoerythrin-conjugated anti-CD42b monoclonal antibody (BD Pharmingen, Tokyo, Japan) and 1 ml of thiazole orange (Retic-COUNT; Becton-Dickinson, San Jose, CA, USA) diluted 10 times by phosphate-buffered saline. RP% was analyzed on a flow cytometer (FACScan, Becton-Dickinson) by measuring 10,000 events in the CD42b-positive fraction.
intervention type: Other
intervention name: RP% Measurement by FCM as a Diagnostic Test for ITP
arm group label: RP% Measurement by FCM as a Diagnostic Test for ITP
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: China
citation: Sakuragi M, Hayashi S, Maruyama M, Kabutomori O, Kiyokawa T, Nagamine K, Kato H, Kashiwagi H, Kanakura Y, Tomiyama Y. Clinical significance of IPF% or RP% measurement in distinguishing primary immune thrombocytopenia from aplastic thrombocytopenic disorders. Int J Hematol. 2015 Apr;101(4):369-75. doi: 10.1007/s12185-015-1741-0. Epub 2015 Jan 25.
PMID: 25618218
citation: Ibrahim H, Nadipalli S, Usmani S, DeLao T, Green L, Kleiman NS. Detection and quantification of circulating immature platelets: agreement between flow cytometric and automated detection. J Thromb Thrombolysis. 2016 Jul;42(1):77-83. doi: 10.1007/s11239-016-1338-3.
PMID: 26831482
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Ming Hou
investigator title: Professor and Director
mesh term: Thrombocytopenia
mesh term: Purpura, Thrombocytopenic, Idiopathic