Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban

  • STATUS
    Recruiting
  • End date
    Dec 23, 2021
  • participants needed
    128
  • sponsor
    Florida Orthopaedic Institute
Updated on 23 January 2021
thrombosis
clot
rivaroxaban
enoxaparin
venous thromboembolism
deep vein thrombosis
thromboembolism
venous thrombosis
deep venous thrombosis of lower extremity
thromboembolism prophylaxis
thrombosis prophylaxis

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.

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.

Details
Condition Venous Thrombosis, Venous Thromboembolism, Thromboembolism, Thrombosis, Blood Clots, Deep Vein Thrombosis, deep venous thrombosis of lower extremity, deep venous thrombosis
Treatment Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters, Rivaroxaban 10 milligram Oral Tablet
Clinical Study IdentifierNCT04169269
SponsorFlorida Orthopaedic Institute
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Venous Thrombosis or Venous Thromboembolism or Blood Clots or Thromboembolism or Deep Vein Thrombosis or Thrombosis?
Do you have any of these conditions: Deep Vein Thrombosis or Venous Thrombosis or Thromboembolism or Blood Clots or deep venous thrombosis of lower extremity or deep venous thrombosis or ...?
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note