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Not Recruiting
Trial ID: NCT02810704
Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement: Balancing Safety and Effectiveness
Boswell Chair of Orthopaedics
Inclusion Criteria:
1. 21 years of age or older;
2. Undergoing elective primary, revision or second stage re-implantation total hip/knee
replacement or uni-compartmental knee replacement or hip resurfacing arthroplasty;
3. Has necessary mental capacity to participate and is able to comply with study protocol
requirements;
4. Eligible for randomization to at least two of the three study regimens;
5. Is not pregnant on the day of surgery;
6. Has signed the consent form; and
7. Is willing to be randomized and participate in the study.
Exclusion Criteria:
1. Undergoing bilateral hip or knee replacement;
2. Has been previously enrolled;
3. Is pregnant or breastfeeding;
4. Is on chronic anticoagulation other than antiplatelet medications;
5. Concurrently enrolled in another active interventional clinical trial testing a drug
or intervention known or believed to interact with aspirin, warfarin, or rivaroxaban;
6. Has documented gastrointestinal, cerebral, or other hemorrhage within 3 months;
7. Has a known diagnosis of defective hemostasis and past history of clinical bleeding
requiring transfusion and treatment;
8. Has had an operative procedure involving the eye, ear, or central nervous system
within one month;
9. Has uncontrolled hypertension with systolic BP > 220mmHg or diastolic BP > 120mmHg;
10. Body weight of less than 41 kilograms at baseline visit;
11. Member of a vulnerable patient population.
drug: Enteric Coated Aspirin
drug: Warfarin
drug: Rivaroxaban
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
William Maloney