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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Once Daily | Experimental | Participant receives 81 mg aspirin taken once daily beginning the night before surgery and up to 28 days post surgery. |
|
| Treatment Twice Daily | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Non-enteric coated 81 mg Aspirin tablet. |
|
| 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 |
| 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 |
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Inclusion criteria:
Exclusion Criteria:
High risk patients for VTE as defined by:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ramakanth Yakkanti, MD | Contact | 502-689-3127 | ramakanth.yakkanti@jhsmiami.org |
| Name | Affiliation | Role |
|---|---|---|
| Victor Hernandez, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Hospital | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |