<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/NCT01727401</url>
  </required_header>
  <id_info>
    <org_study_id>213/2012</org_study_id>
    <nct_id>NCT01727401</nct_id>
  </id_info>
  <brief_title>Thromboprophylaxis of Venous Thromboembolism in Acutely-ill Medical Inpatients With Thrombocytopenia</brief_title>
  <acronym>FAITH</acronym>
  <official_title>Thromboprophylaxis With Fondaparinux of Deep Vein Thrombosis and Pulmonary Embolism in the Acutely-ill Medical Inpatients With Thrombocytopenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>G. d'Annunzio University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>G. d'Annunzio University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fondaparinux is a parenteral anticoagulant drug approved for the prophylaxis of venous&#xD;
      thromboembolism in high risk medical patients. A relevant proportion of these patients have&#xD;
      renal insufficiency and/or thrombocytopenia which represent independent risk factors for&#xD;
      bleeding. The risk of bleeding may be increased when fondaparinux is administered to patients&#xD;
      with a reduced renal function and/or low platelet count. A lower dose of fondaparinux, 1.5 mg&#xD;
      daily, has been approved for patients with renal insufficiency defined by a creatinine&#xD;
      clearance between 20 and 50 mL/min. However, to our knowledge, there are no clinical studies&#xD;
      that have specifically evaluated prophylaxis with fondaparinux in acutely-ill medical&#xD;
      patients with a moderate to severe thrombocytopenia. The scope of this study is to evaluate&#xD;
      the safety of fondaparinux in high risk hospitalized medical patients with a moderate to&#xD;
      severe thrombocytopeniada defined by a platelet count between 100,000/uL and 30,000/uL.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow recruitment rate&#xD;
  </why_stopped>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">July 2021</completion_date>
  <primary_completion_date type="Actual">July 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Major bleeding</measure>
    <time_frame>Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks</time_frame>
    <description>Major bleeding will be defined as overt bleeding associated with: a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or bleeding that occurs in a critical site: intracranial, intra-spinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal or contributing to death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinically relevant non-major bleeding</measure>
    <time_frame>Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks</time_frame>
    <description>clinically relevant non-major bleeding will be defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, unscheduled contact (visit or telephone call) with a physician, (temporary) cessation of study treatment, or associated with discomfort for the patient such as pain, or impairment of activities of daily life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minor Bleeding</measure>
    <time_frame>Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks</time_frame>
    <description>All bleeding events that cannot be classified as major or clinically relevant non-major</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptomatic venous thromboembolism</measure>
    <time_frame>Participants will be followed for the duration of hospital stay up to one month after hospital discharge, an expected average of 5 weeks</time_frame>
    <description>Deep vein thrombosis will be confirmed by compression ultrasonography or venography. Pulmonary embolism will be confirmed by spiral computed tomography or V/Q lung scan</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Medical Patient</condition>
  <condition>Thrombocytopenia</condition>
  <arm_group>
    <arm_group_label>Fondaparinux</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: fondaparinux once daily sc injections 2.5 mg if renal clearance of creatinine above 50 ml/min once daily sc injections 1.5 mg if renal clearance of creatinine between 20 and 50 ml/min</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fondaparinux</intervention_name>
    <description>Fondaparinux once daily sc injections at a dose of 2.5 mg if renal clearance of creatinine above 50 ml/min or Fondaparinux once daily sc injections 1.5 mg if renal clearance of creatinine between 20 and 50 ml/min</description>
    <arm_group_label>Fondaparinux</arm_group_label>
    <other_name>Arixtra</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age above 18 years;&#xD;
&#xD;
          -  hospitalization in an Internal Medicine Unit and a Barbar score of 4 points or above&#xD;
&#xD;
          -  Platelet count between 100,000/uL and 30,000/uL&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active bleeding or bleeding within the previous 3 months;&#xD;
&#xD;
          -  Known bleeding diathesis;&#xD;
&#xD;
          -  Active gastroduodenal ulcer;&#xD;
&#xD;
          -  Severe renal insufficiency defined by a creatinine clearance below 20 mL/min;&#xD;
&#xD;
          -  Ongoing treatment with unfractionated heparin, low-moleculr-weight heparin,&#xD;
             fondaparinux, or oral anticoagulants Trattamento in corso con eparina non&#xD;
&#xD;
          -  Prophylaxis with unfractionated heparin, low-moleculr-weight heparin, or fondaparinux&#xD;
             for more than 48 hours;&#xD;
&#xD;
          -  double antiplatelet therapy or acetylsalicylic acid at daily doses above 165 mg;&#xD;
&#xD;
          -  planned invasive procedure during the period of thromboprophylaxis;&#xD;
&#xD;
          -  Hemoglobin values below 9 g/dL;&#xD;
&#xD;
          -  AST or ALT above 2 times the uper limit of normal;&#xD;
&#xD;
          -  pregnancy or breast feeding;&#xD;
&#xD;
          -  life expectancy lower than 1 month&#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>Marcello Di Nisio, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>G. d'Annunzio University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marcello Di Nisio</name>
      <address>
        <city>Chieti</city>
        <zip>66100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>July 14, 2021</last_update_submitted>
  <last_update_submitted_qc>July 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>G. d'Annunzio University</investigator_affiliation>
    <investigator_full_name>Marcello Di Nisio</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Fondaparinux</keyword>
  <keyword>medical patient</keyword>
  <keyword>vein thromboembolism</keyword>
  <keyword>prophylaxis</keyword>
  <keyword>thrombocytopenia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Thrombocytopenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>PENTA</mesh_term>
    <mesh_term>Fondaparinux</mesh_term>
  </intervention_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/NCT01727401
org study id: 213/2012
nct id: NCT01727401
lead sponsor: 
has dmc: Yes
Fondaparinux is a parenteral anticoagulant drug approved for the prophylaxis of venous
      thromboembolism in high risk medical patients. A relevant proportion of these patients have
      renal insufficiency and/or thrombocytopenia which represent independent risk factors for
      bleeding. The risk of bleeding may be increased when fondaparinux is administered to patients
      with a reduced renal function and/or low platelet count. A lower dose of fondaparinux, 1.5 mg
      daily, has been approved for patients with renal insufficiency defined by a creatinine
      clearance between 20 and 50 mL/min. However, to our knowledge, there are no clinical studies
      that have specifically evaluated prophylaxis with fondaparinux in acutely-ill medical
      patients with a moderate to severe thrombocytopenia. The scope of this study is to evaluate
      the safety of fondaparinux in high risk hospitalized medical patients with a moderate to
      severe thrombocytopeniada defined by a platelet count between 100,000/uL and 30,000/uL.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Major bleeding
time frame: Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks
description: Major bleeding will be defined as overt bleeding associated with: a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or bleeding that occurs in a critical site: intracranial, intra-spinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal or contributing to death.
measure: Clinically relevant non-major bleeding
time frame: Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks
description: clinically relevant non-major bleeding will be defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, unscheduled contact (visit or telephone call) with a physician, (temporary) cessation of study treatment, or associated with discomfort for the patient such as pain, or impairment of activities of daily life.
measure: Minor Bleeding
time frame: Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks
description: All bleeding events that cannot be classified as major or clinically relevant non-major
measure: Symptomatic venous thromboembolism
time frame: Participants will be followed for the duration of hospital stay up to one month after hospital discharge, an expected average of 5 weeks
description: Deep vein thrombosis will be confirmed by compression ultrasonography or venography. Pulmonary embolism will be confirmed by spiral computed tomography or V/Q lung scan
arm group label: Fondaparinux
arm group type: Experimental
description: Drug: fondaparinux once daily sc injections 2.5 mg if renal clearance of creatinine above 50 ml/min once daily sc injections 1.5 mg if renal clearance of creatinine between 20 and 50 ml/min
intervention type: Drug
intervention name: Fondaparinux
description: Fondaparinux once daily sc injections at a dose of 2.5 mg if renal clearance of creatinine above 50 ml/min or Fondaparinux once daily sc injections 1.5 mg if renal clearance of creatinine between 20 and 50 ml/min
arm group label: Fondaparinux
other name: Arixtra
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marcello Di Nisio, PhD
role: Study Chair
affiliation: G. d'Annunzio University
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: G. d'Annunzio University
investigator full name: Marcello Di Nisio
investigator title: Principal Investigator
mesh term: Thromboembolism
mesh term: Thrombocytopenia
mesh term: PENTA
mesh term: Fondaparinux