<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/NCT03814486</url>
  </required_header>
  <id_info>
    <org_study_id>J Moracchini</org_study_id>
    <nct_id>NCT03814486</nct_id>
  </id_info>
  <brief_title>Retrospective Descriptive Study of Platelet Transfusion in Patients With Palliative Hematologic Malignancies at the University Hospital of Besançon</brief_title>
  <official_title>Etude Descriptive Retrospective de la Transfusion Plaquettaire Chez Des Patients Atteints d'hémopathie Maligne en Phase Palliative et Suivis au CHU de Besançon</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Development of palliative care is less effective for patients with hematologic malignancies.&#xD;
      Limited data is available for end of life care in this population, moreover with&#xD;
      thrombocytopenic patients. Thrombopenia is a frequent complication, specific of bone marrow&#xD;
      involvement in those diseases or its treatments. Yet, a few studies was interested in,&#xD;
      whereas platelet transfusion is the only treatment indicated. As it represent a scarce,&#xD;
      limited resource, the ethical principles are in conflict in this setting.&#xD;
&#xD;
      The purpose of this study was to describe retrospectively platelet transfusion in the six&#xD;
      last few month of life of patients with hematologic malignancies at the CHU of Besançon&#xD;
      (France) between 01/07/15 and 31/12/16.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">July 1, 2018</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>evaluate frequency of platelet transfusion at the end of life</measure>
    <time_frame>18 months (between 07/01/2015 and 12/31/2016)</time_frame>
    <description>to calculate the number of platelet transfusion at the end of life. The number of platelet transfusion between 6 months and death are collected in each periods of 2 weeks to calculate the number of transfusion per patient during each 2 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>evaluate efficacy of prophylactic platelet transfusion at the end of life</measure>
    <time_frame>18 months (between 07/01/2015 and 12/31/2016)</time_frame>
    <description>to calculate the platelet yield in percentage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>evaluate efficacy of non prophylactic platelet transfusion at the end of life</measure>
    <time_frame>18 month (between 07/01/2015 and 12/31/2016)</time_frame>
    <description>to calculate the transfusional interval between 2 platelet transfusion in days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>demographic characteristic</measure>
    <time_frame>18 months (between 07/01/2015 and 12/31/2016)</time_frame>
    <description>characteristic of patient (age, diagnosis,location of death, palliative care received...)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">119</enrollment>
  <condition>Platelet Transfusion</condition>
  <condition>Palliative Care</condition>
  <arm_group>
    <arm_group_label>patient transfused in platelet in the 6 last months of life</arm_group_label>
    <description>patient with hematological malignancies follow or hospitalised at least once in CHU of Besancon died in the period of the study transfused at least once in the 6 months of life</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>descriptive</intervention_name>
    <description>evaluate in number and efficacy platelet transfusion at the end of life, demographic characteristic are also noted</description>
    <arm_group_label>patient transfused in platelet in the 6 last months of life</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patient with hematological malignancies,transfused in platelet at least once in the last 6&#xD;
        months of life, hospitalised or follow up at the CHU of Besancon at least once and dead&#xD;
        during the period of the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient with hematological malignancies&#xD;
&#xD;
          -  transfused in platelet at least once in the last 6 months of life&#xD;
&#xD;
          -  hospitalised or follow up at the CHU of Besancon at least once&#xD;
&#xD;
          -  dead during the period of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient with other oncologic malignancies&#xD;
&#xD;
          -  not transfused in platelet in the last 6 months of life&#xD;
&#xD;
          -  never hospitalised or follow up at the CHU of Besancon&#xD;
&#xD;
          -  alive&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>regis aubry, ph</last_name>
    <role>Study Director</role>
    <affiliation>Centre Hospitalier Universitaire de Besancon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Moracchini</name>
      <address>
        <city>Besançon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Hochsmann B, Moicean A, Risitano A, Ljungman P, Schrezenmeier H. Supportive care in severe and very severe aplastic anemia. Bone Marrow Transplant. 2013 Feb;48(2):168-73. doi: 10.1038/bmt.2012.220. Epub 2012 Dec 3.</citation>
    <PMID>23208312</PMID>
  </reference>
  <reference>
    <citation>Sherbeck JP, Boss RD. Ethical Questions about Platelet Transfusions at the End of Life. AMA J Ethics. 2016 Aug 1;18(8):764-70. doi: 10.1001/journalofethics.2016.18.8.ecas1-1608.</citation>
    <PMID>27550559</PMID>
  </reference>
  <reference>
    <citation>Salacz ME, Lankiewicz MW, Weissman DE. Management of thrombocytopenia in bone marrow failure: a review. J Palliat Med. 2007 Feb;10(1):236-44. doi: 10.1089/jpm.2006.0126.</citation>
    <PMID>17298272</PMID>
  </reference>
  <reference>
    <citation>Lassauniere JM, Bertolino M, Hunault M, Zittoun R, Verspieren P, Moh-Klaren J, Jaulmes D, Colombat P. Platelet transfusions in advanced hematological malignancies: a position paper. J Palliat Care. 1996 Spring;12(1):38-41.</citation>
    <PMID>8857246</PMID>
  </reference>
  <reference>
    <citation>Boggs DR. Jehovah's Witnesses with leukemia. Hosp Pract (Off Ed). 1985 Mar 15;20(3):92, 94-5, 98 passim. doi: 10.1080/21548331.1985.11703015. No abstract available.</citation>
    <PMID>2414307</PMID>
  </reference>
  <results_reference>
    <citation>Wang WS, Ma JD, Nelson SH, Revta C, Buckholz GT, Mulroney C, Roeland EJ. Transfusion practices at end of life for hematopoietic stem cell transplant patients. Support Care Cancer. 2018 Jun;26(6):1927-1931. doi: 10.1007/s00520-017-4023-y. Epub 2017 Dec 28.</citation>
    <PMID>29285557</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>platelet transfusion</keyword>
  <keyword>palliative care</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>patient were dead during the period of recruitment. Characteristic of patient could be used for other purpose</ipd_description>
  </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/NCT03814486
org study id: J Moracchini
nct id: NCT03814486
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Development of palliative care is less effective for patients with hematologic malignancies.
      Limited data is available for end of life care in this population, moreover with
      thrombocytopenic patients. Thrombopenia is a frequent complication, specific of bone marrow
      involvement in those diseases or its treatments. Yet, a few studies was interested in,
      whereas platelet transfusion is the only treatment indicated. As it represent a scarce,
      limited resource, the ethical principles are in conflict in this setting.

      The purpose of this study was to describe retrospectively platelet transfusion in the six
      last few month of life of patients with hematologic malignancies at the CHU of Besançon
      (France) between 01/07/15 and 31/12/16.
observational model: Cohort
time perspective: Retrospective
measure: evaluate frequency of platelet transfusion at the end of life
time frame: 18 months (between 07/01/2015 and 12/31/2016)
description: to calculate the number of platelet transfusion at the end of life. The number of platelet transfusion between 6 months and death are collected in each periods of 2 weeks to calculate the number of transfusion per patient during each 2 weeks.
measure: evaluate efficacy of prophylactic platelet transfusion at the end of life
time frame: 18 months (between 07/01/2015 and 12/31/2016)
description: to calculate the platelet yield in percentage
measure: evaluate efficacy of non prophylactic platelet transfusion at the end of life
time frame: 18 month (between 07/01/2015 and 12/31/2016)
description: to calculate the transfusional interval between 2 platelet transfusion in days
measure: demographic characteristic
time frame: 18 months (between 07/01/2015 and 12/31/2016)
description: characteristic of patient (age, diagnosis,location of death, palliative care received...)
arm group label: patient transfused in platelet in the 6 last months of life
description: patient with hematological malignancies follow or hospitalised at least once in CHU of Besancon died in the period of the study transfused at least once in the 6 months of life
intervention type: Other
intervention name: descriptive
description: evaluate in number and efficacy platelet transfusion at the end of life, demographic characteristic are also noted
arm group label: patient transfused in platelet in the 6 last months of life
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: regis aubry, ph
role: Study Director
affiliation: Centre Hospitalier Universitaire de Besancon
facility: 
country: France
citation: Hochsmann B, Moicean A, Risitano A, Ljungman P, Schrezenmeier H. Supportive care in severe and very severe aplastic anemia. Bone Marrow Transplant. 2013 Feb;48(2):168-73. doi: 10.1038/bmt.2012.220. Epub 2012 Dec 3.
PMID: 23208312
citation: Sherbeck JP, Boss RD. Ethical Questions about Platelet Transfusions at the End of Life. AMA J Ethics. 2016 Aug 1;18(8):764-70. doi: 10.1001/journalofethics.2016.18.8.ecas1-1608.
PMID: 27550559
citation: Salacz ME, Lankiewicz MW, Weissman DE. Management of thrombocytopenia in bone marrow failure: a review. J Palliat Med. 2007 Feb;10(1):236-44. doi: 10.1089/jpm.2006.0126.
PMID: 17298272
citation: Lassauniere JM, Bertolino M, Hunault M, Zittoun R, Verspieren P, Moh-Klaren J, Jaulmes D, Colombat P. Platelet transfusions in advanced hematological malignancies: a position paper. J Palliat Care. 1996 Spring;12(1):38-41.
PMID: 8857246
citation: Boggs DR. Jehovah's Witnesses with leukemia. Hosp Pract (Off Ed). 1985 Mar 15;20(3):92, 94-5, 98 passim. doi: 10.1080/21548331.1985.11703015. No abstract available.
PMID: 2414307
citation: Wang WS, Ma JD, Nelson SH, Revta C, Buckholz GT, Mulroney C, Roeland EJ. Transfusion practices at end of life for hematopoietic stem cell transplant patients. Support Care Cancer. 2018 Jun;26(6):1927-1931. doi: 10.1007/s00520-017-4023-y. Epub 2017 Dec 28.
PMID: 29285557
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: patient were dead during the period of recruitment. Characteristic of patient could be used for other purpose