Status:
UNKNOWN
Thromboprophylaxis in Patients Undergoing Orthopedic Surgeries; Using Propensity Score Matching
Lead Sponsor:
Hanoi Medical University
Collaborating Sponsors:
Bach Mai Hospital
Conditions:
Thrombosis
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Brief Summary
Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common post-operative complication. The necessity for anticoagulant therapy after orthopedic surger...
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 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2018
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT03483181
Start Date
January 1 2018
End Date
December 31 2018
Last Update
March 30 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hanoi Medical University
Hanoi, Vietnam, 10000