<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/NCT03027167</url>
  </required_header>
  <id_info>
    <org_study_id>201608075</org_study_id>
    <nct_id>NCT03027167</nct_id>
  </id_info>
  <brief_title>Outcomes Study in Patients Receiving Aspirin With Mechanical Compression Devices Versus Aspirin Alone Following Knee and Hip Arthroplasty</brief_title>
  <acronym>PDAS</acronym>
  <official_title>Outcomes Study to Determine the Incidence of Symptomatic DVT/PE in Patients Receiving Aspirin With Mechanical Compression Devices Versus Aspirin Alone Following Knee and Hip Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Compression Systems</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Purpose is to compare the safety and efficacy of the use of aspirin(ASA) with medical&#xD;
      compression devices versus aspirin alone for venous thromboprophylaxis following knee and hip&#xD;
      arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary&#xD;
      embolism (PE), is the most common complication occurring in association with knee and hip&#xD;
      arthroplasty procedures due to an activation of the clotting cascade during bone and&#xD;
      intramedullary canal preparation.DVT rates ranging from 4% to 15 % and PE rates ranging from&#xD;
      0.83% to 3% have been reported, with fatal PE rates reduced with the use of postoperative&#xD;
      anticoagulation. The high risk of thromboembolic disease has led to recommendations that&#xD;
      pharmacoprophylaxis be considered routinely. • The combination of short duration outpatient&#xD;
      anticoagulation, early mobilization, and mechanical prophylaxis has recently been studied at&#xD;
      our institution (Barnes-Jewish Hospital) and has been effective in prophylaxis against VTE.&#xD;
      Current American College of Chest Physician (ACCP) guidelines recommend that a longer&#xD;
      duration of outpatient anticoagulation following TKA / THA surgery may further reduce the&#xD;
      risk of VTE.&#xD;
&#xD;
      Shorter patient hospitalizations and earlier discharge require an outpatient VTE prophylaxis&#xD;
      regimen that is simple, effective, easy to monitor, predictable, and has a high patient&#xD;
      compliance. Currently, &quot;routine&quot; risk patients receive a combination of ASA 325mg BID (twice&#xD;
      daily) for a period of 6 weeks, and portable, mobile pneumatic compression devices (MCDs) for&#xD;
      a period of 10 days post- surgery.The study is testing to see whether the use of ASA alone&#xD;
      can be equally effective versus the use of ASA with MCDs in &quot;routine&quot; risk patients following&#xD;
      total joint arthroplasty.Patients are enrolled fpr 6 months following surgery, and data&#xD;
      collection occurs pre-surgery, 14 days after surgery, at the 4-8 wk visit and finally, at 6&#xD;
      months post surgery. We are evaluating the stated outcomes over this 6 month period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2023</completion_date>
  <primary_completion_date type="Anticipated">January 2019</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VTE/PE</measure>
    <time_frame>6 months</time_frame>
    <description>Using the MCS (Mobile Compression Systems) Mobile Pumps system for 10 days after surgery from hospital combined with 6 weeks of aspirin will prove superior to the use of 6 weeks of aspirin in the prophylaxis of VTE/PE in standard risk joint arthroplasty patients. Efficacy will be measured in relation to previously published clinical trials with these agents and with previous patient cohorts at our institution.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cessation of anticoagulation therapy for any reason</measure>
    <time_frame>6 months</time_frame>
    <description>Patient reported data will be collected to capture this information.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission to the hospital for any VTE event or surgical site complication in relation to VTE prophylaxis therapy</measure>
    <time_frame>6 months</time_frame>
    <description>Electronic Medical Records will be reviewed and patient reported data will be collected</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>DVT - Deep Vein Thrombosis</condition>
  <condition>PE - Pulmonary Thromboembolism</condition>
  <arm_group>
    <arm_group_label>Aspirin and MCDs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ASA with MCDs- Patients will receive MCDs intraoperatively and during the immediate post-operative recovery period, and will receive MCDs for a period of 10 days post-surgery. ASA 325mg BID will be prescribed for a period of 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aspirin only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ASA only- Patients will receive MCDs intraoperatively and during the immediate post-operative recovery period, and will NOT receive MCDs after being discharged from hospital. ASA 325mg BID will be prescribed for a period of 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <arm_group_label>Aspirin and MCDs</arm_group_label>
    <arm_group_label>Aspirin only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>(Post- discharge) Mechanical Compression Device</intervention_name>
    <arm_group_label>Aspirin and MCDs</arm_group_label>
    <other_name>MCD, compression pump, mobile pumps</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All total knee arthroplasty (TKA), unicompartmental knee arthroplasty (UKA), total hip&#xD;
             arthroplasty (THA), and surface replacement arthroplasty (SRA) patients age 18 or&#xD;
             older and undergoing an elective primary or revision procedure will be eligible to&#xD;
             participate in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded if they are on chronic Coumadin therapy, require prolonged&#xD;
        immobilization (i.e. cast/knee immobilizer; inability to be full weight-bearing and out of&#xD;
        bed on postoperative day 1), and are scheduled to have multiple surgeries in close&#xD;
        proximity to one another. Based on our institution's risk stratification protocol, all&#xD;
        patients deemed &quot;high risk&quot; and meeting one of the following criteria will also be excluded&#xD;
        as they would receive Coumadin for VTE prophylaxis:&#xD;
&#xD;
          1. Patients will be excluded if they are on chronic Coumadin therapy&#xD;
&#xD;
          2. History of DVT/PE&#xD;
&#xD;
          3. Active Cancer&#xD;
&#xD;
          4. Hypercoaguable States (Protein C, Protein S, Factor V Leiden, etc.)&#xD;
&#xD;
          5. Family history of thrombosis -note: we may remove this criteria after further&#xD;
             discussion&#xD;
&#xD;
          6. Patients requiring prolonged immobilization (i.e. cast/knee immobilizer),&#xD;
&#xD;
          7. Patients having multiple surgeries in close proximity to one another.&#xD;
&#xD;
          8. Patients with known allergy or hypersensitivity to Aspirin or Platelet count &lt; 60, 000&#xD;
&#xD;
          9. Patients receiving bilateral joint replacement&#xD;
&#xD;
        Patients who consent to the study and cancel/do not have a surgery scheduled within six&#xD;
        months of signing the consent form will not be included. immobilization (i.e. cast/knee&#xD;
        immobilizer; inability to be full weight-bearing and out of bed on postoperative day 1),&#xD;
        and are scheduled to have multiple surgeries in close proximity to one another. Based on&#xD;
        our institution's risk stratification protocol, all patients deemed &quot;high risk&quot; and meeting&#xD;
        one of the following criteria will also be excluded as they would receive Coumadin for VTE&#xD;
        prophylaxis:&#xD;
&#xD;
          1. Patients will be excluded if they are on chronic Coumadin therapy&#xD;
&#xD;
          2. History of DVT/PE&#xD;
&#xD;
          3. Active Cancer&#xD;
&#xD;
          4. Hypercoaguable States (Protein C, Protein S, Factor V Leiden, etc.)&#xD;
&#xD;
          5. Family history of thrombosis -note: we may remove this criteria after further&#xD;
             discussion&#xD;
&#xD;
          6. Patients requiring prolonged immobilization (i.e. cast/knee immobilizer),&#xD;
&#xD;
          7. Patients having multiple surgeries in close proximity to one another.&#xD;
&#xD;
          8. Patients with known allergy or hypersensitivity to Aspirin or Platelet count &lt; 60, 000&#xD;
&#xD;
          9. Patients receiving bilateral joint replacement&#xD;
&#xD;
        Patients who consent to the study and cancel/do not have a surgery scheduled within six&#xD;
        months of signing the consent form will not be included. (Note: The surgery does not have&#xD;
        to occur within six months of signing the consent form but must be scheduled/re-scheduled&#xD;
        within six months of signing the consent form.) If these patients decide to schedule&#xD;
        surgery after the six months has passed, they will be re-consented at the time they&#xD;
        schedule surgery.&#xD;
&#xD;
        Patients who are not willing to participate will also be excluded from the study.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>May 10, 2017</last_update_submitted>
  <last_update_submitted_qc>May 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03027167
org study id: 201608075
nct id: NCT03027167
lead sponsor: 
collaborator: 
has dmc: No
The Purpose is to compare the safety and efficacy of the use of aspirin(ASA) with medical
      compression devices versus aspirin alone for venous thromboprophylaxis following knee and hip
      arthroplasty.
Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary
      embolism (PE), is the most common complication occurring in association with knee and hip
      arthroplasty procedures due to an activation of the clotting cascade during bone and
      intramedullary canal preparation.DVT rates ranging from 4% to 15 % and PE rates ranging from
      0.83% to 3% have been reported, with fatal PE rates reduced with the use of postoperative
      anticoagulation. The high risk of thromboembolic disease has led to recommendations that
      pharmacoprophylaxis be considered routinely. • The combination of short duration outpatient
      anticoagulation, early mobilization, and mechanical prophylaxis has recently been studied at
      our institution (Barnes-Jewish Hospital) and has been effective in prophylaxis against VTE.
      Current American College of Chest Physician (ACCP) guidelines recommend that a longer
      duration of outpatient anticoagulation following TKA / THA surgery may further reduce the
      risk of VTE.

      Shorter patient hospitalizations and earlier discharge require an outpatient VTE prophylaxis
      regimen that is simple, effective, easy to monitor, predictable, and has a high patient
      compliance. Currently, "routine" risk patients receive a combination of ASA 325mg BID (twice
      daily) for a period of 6 weeks, and portable, mobile pneumatic compression devices (MCDs) for
      a period of 10 days post- surgery.The study is testing to see whether the use of ASA alone
      can be equally effective versus the use of ASA with MCDs in "routine" risk patients following
      total joint arthroplasty.Patients are enrolled fpr 6 months following surgery, and data
      collection occurs pre-surgery, 14 days after surgery, at the 4-8 wk visit and finally, at 6
      months post surgery. We are evaluating the stated outcomes over this 6 month period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: VTE/PE
time frame: 6 months
description: Using the MCS (Mobile Compression Systems) Mobile Pumps system for 10 days after surgery from hospital combined with 6 weeks of aspirin will prove superior to the use of 6 weeks of aspirin in the prophylaxis of VTE/PE in standard risk joint arthroplasty patients. Efficacy will be measured in relation to previously published clinical trials with these agents and with previous patient cohorts at our institution.
measure: Cessation of anticoagulation therapy for any reason
time frame: 6 months
description: Patient reported data will be collected to capture this information.
measure: Readmission to the hospital for any VTE event or surgical site complication in relation to VTE prophylaxis therapy
time frame: 6 months
description: Electronic Medical Records will be reviewed and patient reported data will be collected
arm group label: Aspirin and MCDs
arm group type: Active Comparator
description: ASA with MCDs- Patients will receive MCDs intraoperatively and during the immediate post-operative recovery period, and will receive MCDs for a period of 10 days post-surgery. ASA 325mg BID will be prescribed for a period of 6 weeks.
arm group label: Aspirin only
arm group type: Experimental
description: ASA only- Patients will receive MCDs intraoperatively and during the immediate post-operative recovery period, and will NOT receive MCDs after being discharged from hospital. ASA 325mg BID will be prescribed for a period of 6 weeks.
intervention type: Drug
intervention name: Aspirin
arm group label: Aspirin and MCDs
arm group label: Aspirin only
intervention type: Device
intervention name: (Post- discharge) Mechanical Compression Device
arm group label: Aspirin and MCDs
other name: MCD, compression pump, mobile pumps
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Pulmonary Embolism
mesh term: Thrombosis
mesh term: Thromboembolism
mesh term: Venous Thrombosis
mesh term: Aspirin
sharing ipd: Undecided