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Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban

Primary Purpose

Deep Vein Thrombosis, Venous Thromboembolism

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters
Rivaroxaban 10 milligram Oral Tablet
Sponsored by
Florida Orthopaedic Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Deep Vein Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Florida Orthopaedic InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Enoxaparin

Rivaroxaban

Arm Description

enoxaparin injectable, 40 milligram subcutaneous injection daily for 20 days

rivaroxaban oral 10 milligram tablet daily for 20 days

Outcomes

Primary Outcome Measures

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
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
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.
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.

Secondary Outcome Measures

Number of participants with a bleeding event
measured through record review and participant reporting
Number of participants with a bleeding event
measured through record review and participant reporting
Number of participants with a bleeding event
measured through record review and participant reporting
Number of participants with a clotting event
measured through record review and participant reporting
Number of participants with a clotting event
measured through record review and participant reporting
Number of participants with a clotting event
measured through record review and participant reporting
treatment cost
cost in U.S. dollars for 20 days of treatment drug

Full Information

First Posted
November 15, 2019
Last Updated
January 15, 2020
Sponsor
Florida Orthopaedic Institute
Collaborators
Orthopaedic Trauma Association
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1. Study Identification

Unique Protocol Identification Number
NCT04169269
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida Orthopaedic Institute
Collaborators
Orthopaedic Trauma Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Venous Thromboembolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized to one of two medications.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enoxaparin
Arm Type
Active Comparator
Arm Description
enoxaparin injectable, 40 milligram subcutaneous injection daily for 20 days
Arm Title
Rivaroxaban
Arm Type
Active Comparator
Arm Description
rivaroxaban oral 10 milligram tablet daily for 20 days
Intervention Type
Drug
Intervention Name(s)
Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters
Other Intervention Name(s)
Lovenox
Intervention Description
anticoagulant, subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban 10 milligram Oral Tablet
Other Intervention Name(s)
Xarelto
Intervention Description
anticoagulant, oral
Primary Outcome Measure Information:
Title
adherence to medication regimen
Description
measured with Morisky Medication Adherence Scale instrument; Score range is 0-8, 0 = low adherence to medication regimen, 8 = jigh adherence to medication regimen
Time Frame
2 weeks
Title
adherence to medication regimen
Description
measured with Morisky Medication Adherence Scale instrument; Score range is 0-8, 0 = low adherence to medication regimen, 8 = jigh adherence to medication regimen
Time Frame
6 weeks
Title
patient satisfaction with treatment regimen
Description
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.
Time Frame
2 weeks
Title
patient satisfaction with treatment regimen
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Number of participants with a bleeding event
Description
measured through record review and participant reporting
Time Frame
2 weeks
Title
Number of participants with a bleeding event
Description
measured through record review and participant reporting
Time Frame
6 weeks
Title
Number of participants with a bleeding event
Description
measured through record review and participant reporting
Time Frame
3 months
Title
Number of participants with a clotting event
Description
measured through record review and participant reporting
Time Frame
2 weeks
Title
Number of participants with a clotting event
Description
measured through record review and participant reporting
Time Frame
6 weeks
Title
Number of participants with a clotting event
Description
measured through record review and participant reporting
Time Frame
3 months weeks
Title
treatment cost
Description
cost in U.S. dollars for 20 days of treatment drug
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Steverson, MHA
Phone
8132532068
Email
bsteverson@floridaortho.com
First Name & Middle Initial & Last Name or Official Title & Degree
Randi Alexander, MPH
Phone
8132532068
Email
bsteverson@floridaortho.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Mir, MD
Organizational Affiliation
Florida Orthopaedic Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Orthopaedic Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Steverson, MHA
Phone
813-253-2068
Email
bsteverson@floridaortho.com
First Name & Middle Initial & Last Name & Degree
Randi Alexander, MPH
Phone
8132532068
Email
ralexander@floridaortho.com
First Name & Middle Initial & Last Name & Degree
Hassan Mir, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36399673
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.
Results Reference
derived

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Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban

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