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| Name | Class |
|---|---|
| Orthopaedic Trauma Association | OTHER |
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The objective of this study is to compare oral rivaroxaban with injectable enoxaparin in orthopaedic trauma patients to determine if orally administered rivaroxaban once daily carries greater compliance and overall satisfaction than enoxaparin self-administered by subcutaneous injection once daily.
This study is a randomized, controlled trial of orthopaedic trauma patients presenting to a single academic level one trauma center that require an extended course of venous thromboembolism event chemoprophylaxis. The goal is to compare oral rivaroxaban with our standard-of-care, injectable enoxaparin in orthopaedic trauma patients to determine if orally administered rivaroxaban once daily carries greater compliance and overall satisfaction than enoxaparin self-administered by subcutaneous injection once daily.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enoxaparin | Active Comparator | enoxaparin injectable, 40 milligram subcutaneous injection daily for 20 days |
|
| Rivaroxaban | Active Comparator | rivaroxaban oral 10 milligram tablet daily for 20 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters | Drug | anticoagulant, subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| adherence to medication regimen | measured with Morisky Medication Adherence Scale instrument; Score range is 0-8, 0 = low adherence to medication regimen, 8 = jigh adherence to medication regimen | 2 weeks |
| adherence to medication regimen | measured with Morisky Medication Adherence Scale instrument; Score range is 0-8, 0 = low adherence to medication regimen, 8 = jigh adherence to medication regimen | 6 weeks |
| patient satisfaction with treatment regimen | measured with Treatment Satisfaction Questionnaire for Medication (TSQM-9) instrument. TSQM-9 scores have a range of 0 to 100, with higher scores indicating higher satisfaction. | 2 weeks |
| patient satisfaction with treatment regimen | measured with Treatment Satisfaction Questionnaire for Medication (TSQM-9) instrument. TSQM-9 scores have a range of 0 to 100, with higher scores indicating higher satisfaction. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with a bleeding event | measured through record review and participant reporting | 2 weeks |
| Number of participants with a bleeding event | measured through record review and participant reporting |
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Inclusion Criteria:
• Orthopaedic trauma patients deemed by the attending, treating surgeon to require an extended duration of venous thromboembolism chemoprophylaxis beyond that provided as an inpatient.
Exclusion Criteria:
• Patients being discharged to a rehabilitation center or a skilled nursing facility.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbara Steverson, MHA | Contact | 8132532068 | bsteverson@floridaortho.com | |
| Randi Alexander, MPH | Contact | 8132532068 | bsteverson@floridaortho.com |
| Name | Affiliation | Role |
|---|---|---|
| Hassan Mir, MD | Florida Orthopaedic Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Orthopaedic Institute | Recruiting | Tampa | Florida | 33606 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36399673 | Derived | 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. |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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Participants are randomized to one of two medications.
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| Rivaroxaban 10 milligram Oral Tablet | Drug | anticoagulant, oral |
|
|
| 6 weeks |
| Number of participants with a bleeding event | measured through record review and participant reporting | 3 months |
| Number of participants with a clotting event | measured through record review and participant reporting | 2 weeks |
| Number of participants with a clotting event | measured through record review and participant reporting | 6 weeks |
| Number of participants with a clotting event | measured through record review and participant reporting | 3 months weeks |
| treatment cost | cost in U.S. dollars for 20 days of treatment drug | 3 months |
| D013923 |
| Thromboembolism |
| D002241 |
| Carbohydrates |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |