Overview

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

Status:
Withdrawn
Trial end date:
2023-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Washington University School of Medicine
Collaborator:
Medical Compression Systems
Treatments:
Aspirin
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:

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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