Status:
UNKNOWN
Thromboprophylaxis in Patients Undergoing Orthopedic Surgeries; Comparison Between Rivaroxaban and Enoxaparin
Lead Sponsor:
Ahmed AbdelMoneim Hassan Ali
Collaborating Sponsors:
Beni-Suef University
Conditions:
Thromboses, Deep Vein
Surgery--Complications
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 e...
Detailed Description
There is a Today consensus that patients undergoing high-risk surgery should receive prophylaxis against postoperative venous thromboembolism (VTE). A good example of that could be orthopedic surgerie...
Eligibility Criteria
Inclusion
- Undergo Orthopedic Surgery
- Thromboprophylaxis Decision Taken
- At least 18 years of age
Exclusion
- Planned intermittent pneumatic compression
- A requirement for anticoagulant therapy that could not be stopped
- Severe hypersensitivity reaction (eg, anaphylaxis) to rivaroxaban or enoxaparin.
- Received another anticoagulant for more than 24 hours
- Active bleeding or a high risk of bleeding
- Thrombocytopenia associated with a positive test for antiplatelet antibody.
- Warfarin associated international normalized ratio (INR) more than 1.5 on the day of the surgery
- Conditions preventing bilateral venography
- Intensive care unit (ICU) stay after surgery
- Pregnant or breast-feeding
- Creatinine clearance less than 30 ml per minute or acute renal failure before the surgery or at any point during the study period.
- Moderate or Severe (Child Pugh B or C) hepatic Impairment or in patients with any hepatic disease associated with coagulopathy.
- Concomitant use of drugs that are both P--glycoprotein inhibitors and moderate to strong cyp3a4 (ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir/ritonavir \& conivaptan)
- 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)
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03299296
Start Date
January 1 2017
End Date
March 30 2018
Last Update
October 17 2017
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