Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban
NCT ID: NCT04169269
Last Updated: 2020-01-18
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
PHASE4
128 participants
INTERVENTIONAL
2020-01-13
2021-12-31
Brief Summary
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Detailed Description
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All patients included in the study would be treated with the standard enoxaparin 40 milligram injection while an inpatient. Upon hospital discharge, those requiring extended venous thromboembolism event chemoprophylaxis will be randomized to receive 20 days of either self-injected enoxaparin 40 milligrams or oral rivaroxaban,10 milligrams, a non-vitamin K oral anticoagulant. Both groups will then receive our current standard of care, aspirin 81 milligrams once daily for the remaining 3 weeks, for a total of 6 weeks of venous thromboembolism event chemoprophylaxis. Routine postoperative care will be provided by the treating surgeon.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Enoxaparin
enoxaparin injectable, 40 milligram subcutaneous injection daily for 20 days
Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters
anticoagulant, subcutaneous injection
Rivaroxaban
rivaroxaban oral 10 milligram tablet daily for 20 days
Rivaroxaban 10 milligram Oral Tablet
anticoagulant, oral
Interventions
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Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters
anticoagulant, subcutaneous injection
Rivaroxaban 10 milligram Oral Tablet
anticoagulant, oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients being discharged directly to home.
Exclusion Criteria
* A contraindication to anticoagulation such as traumatic or other hemorrhage, as determined by the treating surgeon and/or consulting services.
* Ongoing venous thromboembolism treatment or extended prophylaxis (i.e. past history of multiple deep vein thrombosis/pulmonary embolism) for current or recent deep vein thrombosis, pulmonary embolism or other coagulopathic disorder
* Chronic anticoagulation for atrial fibrillation or other medical disorder requiring chronic anticoagulation therapy.
* Perceived low-risk patients requiring only aspirin or no pharmacological venous thromboembolism prophylaxis.
* Pregnant, prisoner, under 18 years old, or do not speak English
18 Years
ALL
No
Sponsors
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Orthopaedic Trauma Association
OTHER
Florida Orthopaedic Institute
NETWORK
Responsible Party
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Barbara Steverson
Director of Research, Orthopaedic Trauma Service
Principal Investigators
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Hassan Mir, MD
Role: PRINCIPAL_INVESTIGATOR
Florida Orthopaedic Institute
Locations
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Florida Orthopaedic Institute
Tampa, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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References
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John MP 2nd, Streufert BD, Downes K, Chase CB, Mir HR. A Prospective Randomized Controlled Trial Comparing Enoxaparin & Rivaroxaban for Venous Thromboembolism Prophylaxis in Orthopaedic Trauma. J Orthop Trauma. 2022 Dec 1;36(12):615-622. doi: 10.1097/BOT.0000000000002454.
Other Identifiers
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20192684
Identifier Type: -
Identifier Source: org_study_id
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