Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For VTE Following Total Joint Arthroplasty

Study Overview
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Brief Summary
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This research study is attempting to answer the question of whether 81 mg aspirin once daily is as effective as 81 mg aspirin twice daily in preventing blood clots after total joint replacement surgery.

Official Title
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Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For Venous Thromboembolism (VTE) Following Total Joint Arthroplasty - A Multi-center Prospective Randomized Control Trial.

Conditions
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Venous Thromboembolism

Intervention / Treatment
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* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: > 18 years of age Planning to undergo a primary total hip or knee arthroplasty Exclusion Criteria: High risk patients for VTE as defined by: History of venous thromboembolism Active malignancy Known pro thrombotic condition BMI > 40 Patients requiring anticoagulation for pre-existing conditions Patients with the contraindication for use of aspirin or nonsteroidal antiinflammatory drugs for reasons such as peptic ulcer disease, intolerance, others. Patients not fluent in the language of the informed consent form Prisoners Pregnancy Reported to have mental illness or belonging to a vulnerable population

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Once Daily<br>Participant receives 81 mg aspirin taken once daily beginning the night before surgery and up to 28 days post surgery. | Drug: Aspirin<br>* Non-enteric coated 81 mg Aspirin tablet.<br>|
| Active Comparator: Treatment Twice Daily<br>Participant receives 81 mg aspirin taken twice daily (one in the morning and one at night) beginning at the night before surgery and up to 28 days post surgery. | Drug: Aspirin<br>* Non-enteric coated 81 mg Aspirin tablet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic thromboembolic events | Efficacy of prophylaxis will be reported as the number of reported incidence of symptomatic Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT). | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of specific adverse events | Efficacy of prophylaxis will be reported as the number of reported incidence of specific adverse events including gastrointestinal (GI) complications, post-operative hematoma, bleeding and wound complications and infections. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemoprophylaxis, Hip Surgery, Knee Surgery