Clinical trial NCT04169269: Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban
Official title: Patient Adherence to Venous Thromboembolism Prophylaxis in Orthopaedic Trauma Patients: A Randomized, Controlled Trial Comparing Subcutaneous Enoxaparin & Oral Rivaroxaban
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Deep Vein Thrombosis
Venous Thromboembolism
Lead sponsor: Florida Orthopaedic Institute
Sponsor class: NETWORK
Collaborators: name: Orthopaedic Trauma Association
First posted: 2019-11-19
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to one of two medications.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

  * Patients being discharged directly to home.

Exclusion Criteria:

* • Patients being discharged to a rehabilitation center or a skilled nursing facility.

  * 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

Primary outcomes:
measure: adherence to medication regimen
timeFrame: 2 weeks
measure: adherence to medication regimen
timeFrame: 6 weeks
measure: patient satisfaction with treatment regimen
timeFrame: 2 weeks
measure: patient satisfaction with treatment regimen
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of participants with a bleeding event
timeFrame: 2 weeks
measure: Number of participants with a bleeding event
timeFrame: 6 weeks
measure: Number of participants with a bleeding event
timeFrame: 3 months
measure: Number of participants with a clotting event
timeFrame: 2 weeks
measure: Number of participants with a clotting event
timeFrame: 6 weeks
measure: Number of participants with a clotting event
timeFrame: 3 months weeks
measure: treatment cost
timeFrame: 3 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
Study officials:
affiliation: Florida Orthopaedic Institute
name: Hassan Mir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.