Thromboprophylaxis in Patients Undergoing Orthopedic Surgeries; Comparison Between Rivaroxaban and Enoxaparin

• Status: Unknown status
• Trial end date: 2018-03-30
• Target enrollment: 0
• Participant gender: All

Summary

The main objective is to reduce the incidence of venous thromboembolism (VTE) in orthopedic postoperative patients based on the potential benefit of using rivaroxaban as a monotherapy.

It is around efficacy and safety evaluation of using rivaroxaban as a monotherapy prophylactic agent in patients undergoing orthopedic surgeries taking into the account the reliable selection of patients most benefit.

Answering questions about additional cost benefit from the perceptive of the cost-effective analysis on extrapolating the results emerged to our university teaching hospital setting are going to be evaluating as well.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ahmed AbdelMoneim Hassan Ali
• Collaborators: Beni Suef school of pharmacy; Beni Suef University Teaching Hospital; Beni-Suef University
• Treatments: Enoxaparin; Rivaroxaban

Criteria

Inclusion Criteria:

1. Undergo Orthopedic Surgery

2. Thromboprophylaxis Decision Taken

3. At least 18 years of age

Exclusion Criteria:

1. Planned intermittent pneumatic compression

2. A requirement for anticoagulant therapy that could not be stopped

3. Severe hypersensitivity reaction (eg, anaphylaxis) to rivaroxaban or enoxaparin.

4. Received another anticoagulant for more than 24 hours

5. Active bleeding or a high risk of bleeding

6. Thrombocytopenia associated with a positive test for antiplatelet antibody.

7. Warfarin associated international normalized ratio (INR) more than 1.5 on the day of the surgery

8. Conditions preventing bilateral venography

9. Intensive care unit (ICU) stay after surgery

10. Pregnant or breast-feeding

11. Creatinine clearance less than 30 ml per minute or acute renal failure before the surgery or at any point during the study period.

12. Moderate or Severe (Child Pugh B or C) hepatic Impairment or in patients with any hepatic disease associated with coagulopathy.

13. Concomitant use of drugs that are both P--glycoprotein inhibitors and moderate to strong cyp3a4 (ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir/ritonavir & conivaptan)

14. Creatinine clearance (CrCl) 15 to 80 mL/min and concurrent use of P-glycoprotein inhibitors or moderate CYP3A4 inhibitors (eg, abiraterone acetate, diltiazem, dronedarone, erythromycin, verapamil)