<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/NCT01707732</url>
  </required_header>
  <id_info>
    <org_study_id>2012/056/HP</org_study_id>
    <secondary_id>2012-001414-42</secondary_id>
    <nct_id>NCT01707732</nct_id>
  </id_info>
  <brief_title>Adjusted Value of Thromboprophylaxis in Hospitalized Obese Patients: A Comparative Study of Two Regimens of Enoxaparin</brief_title>
  <acronym>ITOHENOX</acronym>
  <official_title>Adjusted Value of Thromboprophylaxis in Hospitalized Obese Patients: A Comparative Study of Two Regimens of Enoxaparin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Venous thromboembolism (VTE), deep vein thrombosis (DVT) or pulmonary embolism (PE) is a&#xD;
      common medical condition encountered during hospitalization in a medical environment. The use&#xD;
      of thromboprophylaxis with Low Molecular Weight Heparin (LMWH) or fondaparinux has reduced&#xD;
      more than 50% relative risk of thromboembolic complications.However, while obesity defined by&#xD;
      a body mass index (BMI) greater than 30 kg/m2, is a major risk factor for venous thrombotic&#xD;
      events, data on obese patients are limited. In fact, less than 20% of patients included in&#xD;
      the three major studies of preventive medicine had a BMI ≥ 30 kg/m2 and most studies specific&#xD;
      to the obese population comes from a series of bariatric surgery patients or orthopedic&#xD;
      surgery. The main results of this series show regarding the obese population a decrease of&#xD;
      the anti-Xa activity during the administration of a standard dose of enoxaparin (40 mg / d).&#xD;
      However, no specific recommendation in this population has not been published to date and&#xD;
      therefore,the dosages currently used are the same regardless of the patient's weight. In this&#xD;
      context, the use in obese patients hospitalized in a medical environment a stronger dosage of&#xD;
      enoxaparin (60 mg / d) compared to the standard dose of 40 mg / day, could get rates anti-Xa&#xD;
      activity levels more consistent with the treatment required, and thus reduce the risk for&#xD;
      thromboembolic complications in these patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the anti- Xa activity between a standard treatment by Enoxaparin (40mg/ day) and an adapted dose of enoxaparin (60 mg/day) for thromboprophylaxis in obese patients hospitalized</measure>
    <time_frame>3 hours after third Eoxaparin injection</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare the occurrence of symptomatic venous thrombosis (deep venous thrombosis or pulmonary embolism) and the relevant bleeding events according to the enoxaparin treatments</measure>
    <time_frame>All along the study (max 14 days)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Thromboprophylaxis in Hospitalized Obese Patients</condition>
  <arm_group>
    <arm_group_label>Enoxaparin 40mg/ day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Enoxaparin administrated at the following dose : 40mg/ day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enoxaparin 60 mg/day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enoxaparin administrated at the following dose : 60 mg/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enoxaparin</intervention_name>
    <description>Administration of Enoxaparin</description>
    <arm_group_label>Enoxaparin 40mg/ day</arm_group_label>
    <arm_group_label>Enoxaparin 60 mg/day</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient aged ≥ 18 ans.&#xD;
&#xD;
          2. Signed inform consent&#xD;
&#xD;
          3. Obesity defined by a BMI value ≥ 30 kg/m2.&#xD;
&#xD;
          4. Hospitalized for :&#xD;
&#xD;
               -  acute medical affection such as :&#xD;
&#xD;
                    -  congestive heart failure (stage III or IV NYHA),&#xD;
&#xD;
                    -  severe respiratory disease,&#xD;
&#xD;
                    -  Infectious disease or acute rheumatologic disorder or inflammatory bowel&#xD;
                       disease with one or more additional risk factors, including active cancer,&#xD;
                       previous VTE, age &gt; 75 y-o, estrogen therapy, chronic heart failure or&#xD;
                       chronic respiratory disease&#xD;
&#xD;
               -  or recent myocardial infarction(&lt; 6 weeks), recent stroke with hemiparesis (&lt; 15&#xD;
                  days), previous VTE, myeloproliferative syndrome associated with one or more&#xD;
                  additional risk previously cited.&#xD;
&#xD;
          5. Affiliation to a welfare system.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects unwilling or unable to comply with study procedures&#xD;
&#xD;
          2. History of hypersensitivity to enoxaparin heparin induced thrombocytopenia&#xD;
&#xD;
          3. Previous history of heparin induced thrombopenia&#xD;
&#xD;
          4. acquired or inherited bleeding diathesis or coagulopathy,&#xD;
&#xD;
          5. Platelet count &lt; 50.000 G/L,&#xD;
&#xD;
          6. History of clinically significant bleeding&#xD;
&#xD;
          7. Severe renal insufficiency with CrCl &lt;30 ml/min (Cockcroft method),&#xD;
&#xD;
          8. Pregnancy or breastfeeding&#xD;
&#xD;
          9. Women without contraceptive methods&#xD;
&#xD;
         10. Severe peripheral arterial disease (Ankle blood pressure &lt;50mm Hg)&#xD;
&#xD;
         11. Concomitant anticoagulant therapy&#xD;
&#xD;
         12. Severe psychiatric disease&#xD;
&#xD;
         13. History of disease or psychological or sensory anomaly susceptible to prevent the&#xD;
             subject to understand indeed the conditions required for his participation to the&#xD;
             protocol or preventing him from giving its enlightened consent&#xD;
&#xD;
         14. Person deprived of liberty by an administrative or judicial decision, or person under&#xD;
             legal guardianship person&#xD;
&#xD;
         15. Patient participating to a trial or having participated in another medicinal trial&#xD;
             within 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>Ygal BENHAMOU, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rouen University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UH Rouen</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>June 17, 2015</last_update_submitted>
  <last_update_submitted_qc>June 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>thromboprophylaxis</keyword>
  <keyword>Enoxaparin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Enoxaparin</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/NCT01707732
org study id: 2012/056/HP
secondary id: 2012-001414-42
nct id: NCT01707732
lead sponsor: 
has dmc: No
Venous thromboembolism (VTE), deep vein thrombosis (DVT) or pulmonary embolism (PE) is a
      common medical condition encountered during hospitalization in a medical environment. The use
      of thromboprophylaxis with Low Molecular Weight Heparin (LMWH) or fondaparinux has reduced
      more than 50% relative risk of thromboembolic complications.However, while obesity defined by
      a body mass index (BMI) greater than 30 kg/m2, is a major risk factor for venous thrombotic
      events, data on obese patients are limited. In fact, less than 20% of patients included in
      the three major studies of preventive medicine had a BMI ≥ 30 kg/m2 and most studies specific
      to the obese population comes from a series of bariatric surgery patients or orthopedic
      surgery. The main results of this series show regarding the obese population a decrease of
      the anti-Xa activity during the administration of a standard dose of enoxaparin (40 mg / d).
      However, no specific recommendation in this population has not been published to date and
      therefore,the dosages currently used are the same regardless of the patient's weight. In this
      context, the use in obese patients hospitalized in a medical environment a stronger dosage of
      enoxaparin (60 mg / d) compared to the standard dose of 40 mg / day, could get rates anti-Xa
      activity levels more consistent with the treatment required, and thus reduce the risk for
      thromboembolic complications in these patients
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Evaluate the anti- Xa activity between a standard treatment by Enoxaparin (40mg/ day) and an adapted dose of enoxaparin (60 mg/day) for thromboprophylaxis in obese patients hospitalized
time frame: 3 hours after third Eoxaparin injection
measure: Compare the occurrence of symptomatic venous thrombosis (deep venous thrombosis or pulmonary embolism) and the relevant bleeding events according to the enoxaparin treatments
time frame: All along the study (max 14 days)
arm group label: Enoxaparin 40mg/ day
arm group type: Active Comparator
description: Enoxaparin administrated at the following dose : 40mg/ day
arm group label: Enoxaparin 60 mg/day
arm group type: Experimental
description: Enoxaparin administrated at the following dose : 60 mg/day
intervention type: Drug
intervention name: Enoxaparin
description: Administration of Enoxaparin
arm group label: Enoxaparin 40mg/ day
arm group label: Enoxaparin 60 mg/day
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ygal BENHAMOU, MD, PHD
role: Principal Investigator
affiliation: Rouen University Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Obesity
mesh term: Enoxaparin