<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/NCT01696760</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-10055</org_study_id>
    <secondary_id>NCI-2012-00894</secondary_id>
    <nct_id>NCT01696760</nct_id>
  </id_info>
  <brief_title>Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology</brief_title>
  <official_title>Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a research study to compare the efficacy of aspirin (acetylsalicylic acid) and&#xD;
      pneumatic compression devices versus enoxaparin (also known as Lovenox) and pneumatic&#xD;
      compression devices in preventing deep vein thrombosis in patients with pelvic and lower&#xD;
      extremity malignant tumors and undergoing surgery. Pneumatic compression devices are also&#xD;
      known as sequential compression devices and are inflatable compression sleeves that are&#xD;
      placed around patient's legs to reduce the risk of clot formation deep vein thrombosis.&#xD;
      Pneumatic compression devices are made of a soft material that wraps around the lower leg and&#xD;
      periodically squeeze the calf. A deep vein thrombosis is a blood clot. Most hospitalized&#xD;
      patients wear these as a preventive measure. Pneumatic compression devices alone are not&#xD;
      sufficient to prevent deep vein thrombosis formation. Therefore, medicines, such as aspirin&#xD;
      and enoxaparin are utilized. Both drugs are used for prevention, but there are no studies in&#xD;
      patients with musculoskeletal tumors which have determined whether one drug is better than&#xD;
      another. The knowledge gained from this study will determine whether aspirin and pneumatic&#xD;
      compression devices is the same or better than enoxaparin and pneumatic compression devices&#xD;
      in preventing deep vein thrombosis in this patient population and may result in fewer wound&#xD;
      and bleeding complications&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To perform a randomized prospective study to determine efficacy of acetylsalicylic acid&#xD;
      (ASA)+pneumatic compression device (PCD) prophylaxis compared to low-molecular weight heparin&#xD;
      (LMWH)+PCD in patients undergoing orthopaedic procedures for musculoskeletal neoplasms (MSN)&#xD;
      of the pelvis and lower extremity.&#xD;
&#xD;
      II. To prove that ASA+PCD is clinically equivalent to or better than LMWH+PCD in providing&#xD;
      deep vein thrombosis (DVT) prophylaxis in this patient population and results in fewer major&#xD;
      bleeding complications.&#xD;
&#xD;
      III. To measure rates of postoperative DVT and pulmonary embolism (PE) as primary outcomes.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To measure secondary outcomes including rates of readmission, reoperation, bleeding&#xD;
      complications (including hematoma formation and prolonged wound drainage), and death.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 treatment arms.&#xD;
&#xD;
      ARM I: Patients receive acetylsalicylic acid orally (PO) twice daily (BID) and wear PCD on&#xD;
      days 1-28 after surgery.&#xD;
&#xD;
      ARM II: Patients receive enoxaparin subcutaneously (SC) once daily (QD) and wear PCD on days&#xD;
      1-28 after surgery.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 2 weeks, 6 weeks, and 3&#xD;
      months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2010</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>DVT Incident Rate</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>This study will test if the ASA+PCD treatment group has a DVT rate (P1) not more than the DVT rate of the LMWH+PCD treatment group (P0) using a one sided test for these two proportions. Statistical significance will be defined as p &lt; 0.05.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pulmonary Embolism Rate</measure>
    <time_frame>Up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of Other Complications (Including Bleeding Complications)</measure>
    <time_frame>Up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission Rate to Hopsital</measure>
    <time_frame>Up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematoma Formation</measure>
    <time_frame>Up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Excessive Wound Drainage</measure>
    <time_frame>Up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death Rate</measure>
    <time_frame>Up to 3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Bone Metastases</condition>
  <condition>Musculoskeletal Cancer</condition>
  <condition>Soft Tissue Sarcoma</condition>
  <condition>Thromboembolism</condition>
  <arm_group>
    <arm_group_label>Arm I (acetylsalicylic acid and PCD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (enoxaparin and PCD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>acetylsalicylic acid</intervention_name>
    <description>325 mg twice a day</description>
    <arm_group_label>Arm I (acetylsalicylic acid and PCD)</arm_group_label>
    <other_name>ASA</other_name>
    <other_name>Ecotrin</other_name>
    <other_name>Empirin</other_name>
    <other_name>Extren</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>enoxaparin</intervention_name>
    <description>40 mg once daily</description>
    <arm_group_label>Arm II (enoxaparin and PCD)</arm_group_label>
    <other_name>Enoxaparin Sodium</other_name>
    <other_name>Lovenox</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PCD</intervention_name>
    <description>Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
    <arm_group_label>Arm I (acetylsalicylic acid and PCD)</arm_group_label>
    <arm_group_label>Arm II (enoxaparin and PCD)</arm_group_label>
    <other_name>thromboembolism prophylaxis</other_name>
    <other_name>Flowtron calf compression</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Scheduled or to be scheduled for surgery performed on neoplasms of the pelvis or lower&#xD;
        limbs, including both primary musculoskeletal lesions as well as metastatic lesions; these&#xD;
        neoplasms may include major tumor resections, metastatic and pathologic fractures of the&#xD;
        hip and lower extremities (LE), open biopsies, and primary malignant tumors; an active&#xD;
        malignant neoplasm must be present at the time of surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior history of DVT or PE&#xD;
&#xD;
          -  Previously placed vena cava filter&#xD;
&#xD;
          -  No detectable malignant disease at the time of operation&#xD;
&#xD;
          -  Previous arterial thrombosis (myocardial infarction [MI], cerebral vascular accident&#xD;
             [CVA])&#xD;
&#xD;
          -  Severe platelet dysfunction (uremia, medications, dysplastic hematopoiesis); excluded&#xD;
             if platelets &lt; 50,000&#xD;
&#xD;
          -  Preoperative anticoagulation or active/serious bleeding in past 2 weeks (prothrombin&#xD;
             time [PT] &amp; partial thromboplastin time [PTT] &gt; 1.6 &amp; &gt; 35)&#xD;
&#xD;
          -  Hypersensitivity or allergy to aspirin or heparin (including those diagnosed with&#xD;
             heparin-induced thrombocytopenia)&#xD;
&#xD;
          -  Conditions associated with bleeding (active ulcer disease, recent neurosurgery,&#xD;
             bleeding disorders)&#xD;
&#xD;
          -  Patients with renal insufficiency (creatinine [Cr] &gt; 1.5)&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Epidural anesthesia&#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>Joel Mayerson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>Jamesline</description>
  </link>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <results_first_submitted>June 4, 2014</results_first_submitted>
  <results_first_submitted_qc>June 4, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 4, 2014</results_first_posted>
  <last_update_submitted>November 9, 2018</last_update_submitted>
  <last_update_submitted_qc>November 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
    <investigator_full_name>Joel Mayerson</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Enoxaparin</mesh_term>
    <mesh_term>Enoxaparin sodium</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Arm I (Acetylsalicylic Acid and PCD)</title>
          <description>Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.&#xD;
acetylsalicylic acid: 325 mg twice a day&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
        </group>
        <group group_id="P2">
          <title>Arm II (Enoxaparin and PCD)</title>
          <description>Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.&#xD;
enoxaparin: 40 mg once daily&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Arm I (Acetylsalicylic Acid and PCD)</title>
          <description>Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.&#xD;
acetylsalicylic acid: 325 mg twice a day&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
        </group>
        <group group_id="B2">
          <title>Arm II (Enoxaparin and PCD)</title>
          <description>Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.&#xD;
enoxaparin: 40 mg once daily&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>DVT Incident Rate</title>
        <description>This study will test if the ASA+PCD treatment group has a DVT rate (P1) not more than the DVT rate of the LMWH+PCD treatment group (P0) using a one sided test for these two proportions. Statistical significance will be defined as p &lt; 0.05.</description>
        <time_frame>Up to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm I (Acetylsalicylic Acid and PCD)</title>
            <description>Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.&#xD;
acetylsalicylic acid: 325 mg twice a day&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
          </group>
          <group group_id="O2">
            <title>Arm II (Enoxaparin and PCD)</title>
            <description>Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.&#xD;
enoxaparin: 40 mg once daily&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>DVT Incident Rate</title>
          <description>This study will test if the ASA+PCD treatment group has a DVT rate (P1) not more than the DVT rate of the LMWH+PCD treatment group (P0) using a one sided test for these two proportions. Statistical significance will be defined as p &lt; 0.05.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pulmonary Embolism Rate</title>
        <time_frame>Up to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm I (Acetylsalicylic Acid and PCD)</title>
            <description>Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.&#xD;
acetylsalicylic acid: 325 mg twice a day&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
          </group>
          <group group_id="O2">
            <title>Arm II (Enoxaparin and PCD)</title>
            <description>Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.&#xD;
enoxaparin: 40 mg once daily&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Pulmonary Embolism Rate</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Development of Other Complications (Including Bleeding Complications)</title>
        <time_frame>Up to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm I (Acetylsalicylic Acid and PCD)</title>
            <description>Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.&#xD;
acetylsalicylic acid: 325 mg twice a day&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
          </group>
          <group group_id="O2">
            <title>Arm II (Enoxaparin and PCD)</title>
            <description>Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.&#xD;
enoxaparin: 40 mg once daily&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Development of Other Complications (Including Bleeding Complications)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Readmission Rate to Hopsital</title>
        <time_frame>Up to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm I (Acetylsalicylic Acid and PCD)</title>
            <description>Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.&#xD;
acetylsalicylic acid: 325 mg twice a day&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
          </group>
          <group group_id="O2">
            <title>Arm II (Enoxaparin and PCD)</title>
            <description>Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.&#xD;
enoxaparin: 40 mg once daily&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Readmission Rate to Hopsital</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hematoma Formation</title>
        <time_frame>Up to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm I (Acetylsalicylic Acid and PCD)</title>
            <description>Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.&#xD;
acetylsalicylic acid: 325 mg twice a day&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
          </group>
          <group group_id="O2">
            <title>Arm II (Enoxaparin and PCD)</title>
            <description>Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.&#xD;
enoxaparin: 40 mg once daily&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Hematoma Formation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Excessive Wound Drainage</title>
        <time_frame>Up to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm I (Acetylsalicylic Acid and PCD)</title>
            <description>Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.&#xD;
acetylsalicylic acid: 325 mg twice a day&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
          </group>
          <group group_id="O2">
            <title>Arm II (Enoxaparin and PCD)</title>
            <description>Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.&#xD;
enoxaparin: 40 mg once daily&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Excessive Wound Drainage</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Death Rate</title>
        <time_frame>Up to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm I (Acetylsalicylic Acid and PCD)</title>
            <description>Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.&#xD;
acetylsalicylic acid: 325 mg twice a day&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
          </group>
          <group group_id="O2">
            <title>Arm II (Enoxaparin and PCD)</title>
            <description>Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.&#xD;
enoxaparin: 40 mg once daily&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Death Rate</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Arm I (Acetylsalicylic Acid and PCD)</title>
          <description>Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.&#xD;
acetylsalicylic acid: 325 mg twice a day&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
        </group>
        <group group_id="E2">
          <title>Arm II (Enoxaparin and PCD)</title>
          <description>Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.&#xD;
enoxaparin: 40 mg once daily&#xD;
PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Overall patient compliance for the study was low</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Joel Mayerson, MD</name_or_title>
      <organization>The Ohio State University Comprehensive Cancer Center</organization>
      <phone>614-293-4420</phone>
      <email>joel.mayerson@osumc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01696760
org study id: OSU-10055
secondary id: NCI-2012-00894
nct id: NCT01696760
lead sponsor: 
has dmc: Yes
This is a research study to compare the efficacy of aspirin (acetylsalicylic acid) and
      pneumatic compression devices versus enoxaparin (also known as Lovenox) and pneumatic
      compression devices in preventing deep vein thrombosis in patients with pelvic and lower
      extremity malignant tumors and undergoing surgery. Pneumatic compression devices are also
      known as sequential compression devices and are inflatable compression sleeves that are
      placed around patient's legs to reduce the risk of clot formation deep vein thrombosis.
      Pneumatic compression devices are made of a soft material that wraps around the lower leg and
      periodically squeeze the calf. A deep vein thrombosis is a blood clot. Most hospitalized
      patients wear these as a preventive measure. Pneumatic compression devices alone are not
      sufficient to prevent deep vein thrombosis formation. Therefore, medicines, such as aspirin
      and enoxaparin are utilized. Both drugs are used for prevention, but there are no studies in
      patients with musculoskeletal tumors which have determined whether one drug is better than
      another. The knowledge gained from this study will determine whether aspirin and pneumatic
      compression devices is the same or better than enoxaparin and pneumatic compression devices
      in preventing deep vein thrombosis in this patient population and may result in fewer wound
      and bleeding complications
PRIMARY OBJECTIVES:

      I. To perform a randomized prospective study to determine efficacy of acetylsalicylic acid
      (ASA)+pneumatic compression device (PCD) prophylaxis compared to low-molecular weight heparin
      (LMWH)+PCD in patients undergoing orthopaedic procedures for musculoskeletal neoplasms (MSN)
      of the pelvis and lower extremity.

      II. To prove that ASA+PCD is clinically equivalent to or better than LMWH+PCD in providing
      deep vein thrombosis (DVT) prophylaxis in this patient population and results in fewer major
      bleeding complications.

      III. To measure rates of postoperative DVT and pulmonary embolism (PE) as primary outcomes.

      SECONDARY OBJECTIVES:

      I. To measure secondary outcomes including rates of readmission, reoperation, bleeding
      complications (including hematoma formation and prolonged wound drainage), and death.

      OUTLINE: Patients are randomized to 1 of 2 treatment arms.

      ARM I: Patients receive acetylsalicylic acid orally (PO) twice daily (BID) and wear PCD on
      days 1-28 after surgery.

      ARM II: Patients receive enoxaparin subcutaneously (SC) once daily (QD) and wear PCD on days
      1-28 after surgery.

      After completion of study treatment, patients are followed up at 2 weeks, 6 weeks, and 3
      months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: DVT Incident Rate
time frame: Up to 3 months
description: This study will test if the ASA+PCD treatment group has a DVT rate (P1) not more than the DVT rate of the LMWH+PCD treatment group (P0) using a one sided test for these two proportions. Statistical significance will be defined as p < 0.05.
measure: Pulmonary Embolism Rate
time frame: Up to 3 months
measure: Development of Other Complications (Including Bleeding Complications)
time frame: Up to 3 months
measure: Readmission Rate to Hopsital
time frame: Up to 3 months
measure: Hematoma Formation
time frame: Up to 3 months
measure: Excessive Wound Drainage
time frame: Up to 3 months
measure: Death Rate
time frame: Up to 3 months
arm group label: Arm I (acetylsalicylic acid and PCD)
arm group type: Experimental
description: Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.
arm group label: Arm II (enoxaparin and PCD)
arm group type: Experimental
description: Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.
intervention type: Drug
intervention name: acetylsalicylic acid
description: 325 mg twice a day
arm group label: Arm I (acetylsalicylic acid and PCD)
other name: ASA
other name: Ecotrin
other name: Empirin
other name: Extren
intervention type: Drug
intervention name: enoxaparin
description: 40 mg once daily
arm group label: Arm II (enoxaparin and PCD)
other name: Enoxaparin Sodium
other name: Lovenox
intervention type: Device
intervention name: PCD
description: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.
arm group label: Arm I (acetylsalicylic acid and PCD)
arm group label: Arm II (enoxaparin and PCD)
other name: thromboembolism prophylaxis
other name: Flowtron calf compression
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joel Mayerson, MD
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
url: http://cancer.osu.edu
description: Jamesline
responsible party type: Principal Investigator
investigator affiliation: Ohio State University Comprehensive Cancer Center
investigator full name: Joel Mayerson
investigator title: Principal Investigator
mesh term: Sarcoma
mesh term: Thromboembolism
mesh term: Aspirin
mesh term: Enoxaparin
mesh term: Enoxaparin sodium
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Overall patient compliance for the study was low
point of contact: 