Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban

Florida Orthopaedic Institute

Status and phase: Unknown; Phase 4

Conditions: Venous Thromboembolism; Deep Vein Thrombosis

Treatments: Drug: Rivaroxaban 10 milligram Oral Tablet; Drug: Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT04169269

20192684

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Enoxaparin

Active Comparator group

Description:

enoxaparin injectable, 40 milligram subcutaneous injection daily for 20 days

Treatment:

Drug: Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters

Rivaroxaban

Active Comparator group

Description:

rivaroxaban oral 10 milligram tablet daily for 20 days

Treatment:

Drug: Rivaroxaban 10 milligram Oral Tablet