VTE Prevention Following Total Hip and Knee Arthroplasty

Launched by SUDEEP SHIVAKUMAR · Aug 29, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at ways to prevent a serious condition called venous thromboembolism (VTE), which can happen after surgeries like total hip and total knee replacements. In this study, patients who are having these surgeries will be randomly assigned to take either aspirin alone or a combination of aspirin and another medication called rivaroxaban. The goal is to see which approach is more effective at preventing VTE.

To participate in this study, you need to be between the ages of 65 and 74 and scheduled for elective hip or knee surgery. You also need to provide written consent to be part of the trial. However, if you have a history of certain health issues, like previous blood clots, major bleeding problems, or specific types of cancer, you may not be eligible. If you join the study, you'll receive either of the two treatments and will be monitored for any side effects or improvements in your condition. This research is important because it aims to find better ways to keep patients safe after their surgeries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients undergoing elective THA/TKA at the participating institutions will be potentially eligible for this study
• • 2. Written informed consent in accordance with federal, local and institutional guidelines
• Exclusion Criteria:
• • 1. Previous documented VTE (proximal DVT or any PE)
• • 2. Hip or lower limb fracture in the previous three months, not related to present surgery
• • 3. Metastatic cancer
• • 4. Life expectancy less than 6 months
• • 5. History of major bleeding that in the judgment of the investigator precludes use of anticoagulant prophylaxis
• • 6. History of aspirin allergy, active peptic ulcer disease or gastritis that in the judgment of investigator precludes use of aspirin
• • 7. History of significant hepatic disease or any other condition that in the judgment of the investigator precludes the use of rivaroxaban
• • 8. Creatinine clearance less than 15 ml per minute
• • 9. Pre-operative platelet count less than 100 x 109 /L
• • 10. Need for long-term anticoagulation due to a pre-existing co-morbid condition or due to the development of VTE following surgery but prior to randomization
• • 11. Received anticoagulation post operatively
• • 12. Bilateral THA/TKA or simultaneous hip and knee arthroplasty
• • 13. Major surgical procedure within the previous 3 months
• • 14. Requirement for major surgery post arthroplasty within a 90 day period
• • 15. Chronic daily aspirin use with dose greater than 100 mg a day
• • 16. Women of childbearing potential who are not abstinent or do not use effective contraception or are breast-feeding throughout the study drug period
• • 17. Unwilling or unable to give consent
• • 18. Previous participation in the EPCAT III study
• • 19. Under 18 years of age
• • 20. Concomitant use of drugs that are strong inhibitors of P-gp AND CYP3A4 (e.g., systemic treatment with ketoconazole, itraconazole, or ritonavir) or strong inducers of P-gp AND CYP3A4 (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's Wort)
• • 21. Known allergy to food dye