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Outcomes Study in Patients Receiving Aspirin With Mechanical Compression Devices Versus Aspirin Alone Following Knee and Hip Arthroplasty (PDAS)

Primary Purpose

DVT - Deep Vein Thrombosis, PE - Pulmonary Thromboembolism

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Aspirin
(Post- discharge) Mechanical Compression Device
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for DVT - Deep Vein Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All total knee arthroplasty (TKA), unicompartmental knee arthroplasty (UKA), total hip arthroplasty (THA), and surface replacement arthroplasty (SRA) patients age 18 or older and undergoing an elective primary or revision procedure will be eligible to participate in this study.

Exclusion Criteria:

Patients will be excluded if they are on chronic Coumadin therapy, require prolonged immobilization (i.e. cast/knee immobilizer; inability to be full weight-bearing and out of bed on postoperative day 1), and are scheduled to have multiple surgeries in close proximity to one another. Based on our institution's risk stratification protocol, all patients deemed "high risk" and meeting one of the following criteria will also be excluded as they would receive Coumadin for VTE prophylaxis:

  1. Patients will be excluded if they are on chronic Coumadin therapy
  2. History of DVT/PE
  3. Active Cancer
  4. Hypercoaguable States (Protein C, Protein S, Factor V Leiden, etc.)
  5. Family history of thrombosis -note: we may remove this criteria after further discussion
  6. Patients requiring prolonged immobilization (i.e. cast/knee immobilizer),
  7. Patients having multiple surgeries in close proximity to one another.
  8. Patients with known allergy or hypersensitivity to Aspirin or Platelet count < 60, 000
  9. Patients receiving bilateral joint replacement

Patients who consent to the study and cancel/do not have a surgery scheduled within six months of signing the consent form will not be included. immobilization (i.e. cast/knee immobilizer; inability to be full weight-bearing and out of bed on postoperative day 1), and are scheduled to have multiple surgeries in close proximity to one another. Based on our institution's risk stratification protocol, all patients deemed "high risk" and meeting one of the following criteria will also be excluded as they would receive Coumadin for VTE prophylaxis:

  1. Patients will be excluded if they are on chronic Coumadin therapy
  2. History of DVT/PE
  3. Active Cancer
  4. Hypercoaguable States (Protein C, Protein S, Factor V Leiden, etc.)
  5. Family history of thrombosis -note: we may remove this criteria after further discussion
  6. Patients requiring prolonged immobilization (i.e. cast/knee immobilizer),
  7. Patients having multiple surgeries in close proximity to one another.
  8. Patients with known allergy or hypersensitivity to Aspirin or Platelet count < 60, 000
  9. Patients receiving bilateral joint replacement

Patients who consent to the study and cancel/do not have a surgery scheduled within six months of signing the consent form will not be included. (Note: The surgery does not have to occur within six months of signing the consent form but must be scheduled/re-scheduled within six months of signing the consent form.) If these patients decide to schedule surgery after the six months has passed, they will be re-consented at the time they schedule surgery.

Patients who are not willing to participate will also be excluded from the study.

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Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Aspirin and MCDs

    Aspirin only

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    VTE/PE
    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.

    Secondary Outcome Measures

    Cessation of anticoagulation therapy for any reason
    Patient reported data will be collected to capture this information.
    Readmission to the hospital for any VTE event or surgical site complication in relation to VTE prophylaxis therapy
    Electronic Medical Records will be reviewed and patient reported data will be collected

    Full Information

    First Posted
    January 3, 2017
    Last Updated
    May 10, 2017
    Sponsor
    Washington University School of Medicine
    Collaborators
    Medical Compression Systems
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03027167
    Brief Title
    Outcomes Study in Patients Receiving Aspirin With Mechanical Compression Devices Versus Aspirin Alone Following Knee and Hip Arthroplasty
    Acronym
    PDAS
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    January 2019 (Anticipated)
    Study Completion Date
    January 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Washington University School of Medicine
    Collaborators
    Medical Compression Systems

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    DVT - Deep Vein Thrombosis, PE - Pulmonary Thromboembolism

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Aspirin and MCDs
    Arm Type
    Active Comparator
    Arm 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 Title
    Aspirin only
    Arm Type
    Experimental
    Arm 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(s)
    Aspirin
    Intervention Type
    Device
    Intervention Name(s)
    (Post- discharge) Mechanical Compression Device
    Other Intervention Name(s)
    MCD, compression pump, mobile pumps
    Primary Outcome Measure Information:
    Title
    VTE/PE
    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.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Cessation of anticoagulation therapy for any reason
    Description
    Patient reported data will be collected to capture this information.
    Time Frame
    6 months
    Title
    Readmission to the hospital for any VTE event or surgical site complication in relation to VTE prophylaxis therapy
    Description
    Electronic Medical Records will be reviewed and patient reported data will be collected
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All total knee arthroplasty (TKA), unicompartmental knee arthroplasty (UKA), total hip arthroplasty (THA), and surface replacement arthroplasty (SRA) patients age 18 or older and undergoing an elective primary or revision procedure will be eligible to participate in this study. Exclusion Criteria: Patients will be excluded if they are on chronic Coumadin therapy, require prolonged immobilization (i.e. cast/knee immobilizer; inability to be full weight-bearing and out of bed on postoperative day 1), and are scheduled to have multiple surgeries in close proximity to one another. Based on our institution's risk stratification protocol, all patients deemed "high risk" and meeting one of the following criteria will also be excluded as they would receive Coumadin for VTE prophylaxis: Patients will be excluded if they are on chronic Coumadin therapy History of DVT/PE Active Cancer Hypercoaguable States (Protein C, Protein S, Factor V Leiden, etc.) Family history of thrombosis -note: we may remove this criteria after further discussion Patients requiring prolonged immobilization (i.e. cast/knee immobilizer), Patients having multiple surgeries in close proximity to one another. Patients with known allergy or hypersensitivity to Aspirin or Platelet count < 60, 000 Patients receiving bilateral joint replacement Patients who consent to the study and cancel/do not have a surgery scheduled within six months of signing the consent form will not be included. immobilization (i.e. cast/knee immobilizer; inability to be full weight-bearing and out of bed on postoperative day 1), and are scheduled to have multiple surgeries in close proximity to one another. Based on our institution's risk stratification protocol, all patients deemed "high risk" and meeting one of the following criteria will also be excluded as they would receive Coumadin for VTE prophylaxis: Patients will be excluded if they are on chronic Coumadin therapy History of DVT/PE Active Cancer Hypercoaguable States (Protein C, Protein S, Factor V Leiden, etc.) Family history of thrombosis -note: we may remove this criteria after further discussion Patients requiring prolonged immobilization (i.e. cast/knee immobilizer), Patients having multiple surgeries in close proximity to one another. Patients with known allergy or hypersensitivity to Aspirin or Platelet count < 60, 000 Patients receiving bilateral joint replacement Patients who consent to the study and cancel/do not have a surgery scheduled within six months of signing the consent form will not be included. (Note: The surgery does not have to occur within six months of signing the consent form but must be scheduled/re-scheduled within six months of signing the consent form.) If these patients decide to schedule surgery after the six months has passed, they will be re-consented at the time they schedule surgery. Patients who are not willing to participate will also be excluded from the study. -

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Outcomes Study in Patients Receiving Aspirin With Mechanical Compression Devices Versus Aspirin Alone Following Knee and Hip Arthroplasty

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