Thromboprophylaxis in Patients Undergoing Orthopedic Surgeries; Using Propensity Score Matching
NCT ID: NCT03483181
Last Updated: 2018-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
4000 participants
OBSERVATIONAL
2018-01-01
2018-12-31
Brief Summary
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The main objective of this study is to perform a comparative effectiveness review examining the benefits and harms associated with venous thromboembolism prophylaxis in patients undergoing orthopedic surgeries.
It is around efficacy and safety evaluation of using anticoagulant for thromboprophylaxis in patients undergoing orthopedic surgeries taking into the account the reliable selection of patients most benefit.
The aims of this study is to analyze patient records in teaching hospitals database of our country (including: Hanoi Medical University, Bach Mai Hospital, Cho Ray Hospital, Viet Duc University Hospital) and compare the outcomes and costs between different types of anticoagulant medications that were prescribed for the prevention of VTE following orthopedic surgeries. This analysis will assess and quantify the outcomes, resource utilization, and cost of care for patients receiving rivaroxaban or enoxaparin. The outcomes of interest include the occurence of DVT and PE, rates of major bleeds, medical resource utilization, and total costs (medical plus pharmacy).
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Orthopedic surgery patient records
Medical records from patients aged 18 years or older with orthopedic surgeries during the hospitalization
Xarelto (rivaroxaban)
An oral anticoagulant medication for the prevention of VTE (Venous thromboembolism) related to orthopedic surgery. Patients received rivaroxaban during one day prior to or two days after orthopedic surgery during the hospitalization.
Lovenox (enoxaparin)
An injectable anticoagulant medication for the prevention of VTE (Venous thromboembolism) related to orthopedic surgery. Patients received enoxaparin during one day prior to or two days after orthopedic surgeries during the hospitalization.
Interventions
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Xarelto (rivaroxaban)
An oral anticoagulant medication for the prevention of VTE (Venous thromboembolism) related to orthopedic surgery. Patients received rivaroxaban during one day prior to or two days after orthopedic surgery during the hospitalization.
Lovenox (enoxaparin)
An injectable anticoagulant medication for the prevention of VTE (Venous thromboembolism) related to orthopedic surgery. Patients received enoxaparin during one day prior to or two days after orthopedic surgeries during the hospitalization.
Eligibility Criteria
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Inclusion Criteria
* Thromboprophylaxis Decision Taken
* At least 18 years of age
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Bach Mai Hospital
OTHER
Hanoi Medical University
OTHER
Responsible Party
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Bui My Hanh
Director, Science Research and International Cooperation Unit
Locations
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Hanoi Medical University
Hanoi, , Vietnam
Countries
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Central Contacts
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Facility Contacts
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Bui My Hanh, MD
Role: primary
Nguyen Hoang Hiep, BSc
Role: backup
Other Identifiers
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ĐTĐL.CN.53/16
Identifier Type: -
Identifier Source: org_study_id