Recruiting

Enoxaparin vs. Rivaroxaban

Sponsor:

Florida Orthopaedic Institute

Code:

NCT04169269

Conditions

Deep Vein Thrombosis

Venous Thromboembolism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters

Rivaroxaban 10 milligram Oral Tablet

Study Details

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.

Conditions

Deep Vein Thrombosis

Venous Thromboembolism

Study ID

NCT04169269

Start date

Jan 13, 2020

Status verified date

Jan, 2020

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Enoxaparin

enoxaparin injectable, 40 milligram subcutaneous injection daily for 20 days

active comparator: Rivaroxaban

rivaroxaban oral 10 milligram tablet daily for 20 days

Interventions

Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters

anticoagulant, subcutaneous injection

Rivaroxaban 10 milligram Oral Tablet

anticoagulant, oral

Primary outcome measure

  • adherence to medication regimen [ Time Frame: 2 weeks ]
  • adherence to medication regimen [ Time Frame: 6 weeks ]
  • patient satisfaction with treatment regimen [ Time Frame: 2 weeks ]
  • patient satisfaction with treatment regimen [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Barbara Steverson, MHA

8132532068bsteverson@floridaortho.com

Randi Alexander, MPH

8132532068bsteverson@floridaortho.com

Locations

Florida Orthopaedic Institute

Recruiting

Tampa, Florida, United States, 33606

Contacts

Barbara Steverson, MHA

813-253-2068bsteverson@floridaortho.com

Randi Alexander, MPH

8132532068ralexander@floridaortho.com

Principal Investigator:

Hassan Mir, MD

More Information

Sponsor

Florida Orthopaedic Institute

Last update posted

Jan 18, 2020

Last verified

Jan, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Florida Orthopaedic Institute on 2020-01-18.