Weight-Based Enoxaparin Dosing and Real-Time Dose Adjustment in Orthopaedic Trauma
Primary Purpose
Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolus
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enoxaparin
Sponsored by
About this trial
This is an interventional other trial for Venous Thromboembolism
Eligibility Criteria
Inclusion Criteria:
- Receiving orthopedic trauma surgery
- Able to have enoxaparin initiated within 36 hours after procedure
Exclusion Criteria:
- Intracranial bleeding/stroke
- bleeding disorder
- heparin-induced thrombocytopenia
- creatinine clearance < 30 mL/minute
- epidural catheter
- serum creatinine > 1.6 mg/dL
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Enoxaparin Metabolism
Arm Description
Eligible patients will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.2-0.4 IU/mL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
Outcomes
Primary Outcome Measures
Number of Participants with Venous Thromboembolism Events
Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery
Number of Participants with Bleeding Events
Bleeding events requiring alteration in the course of care within 90 days of surgery
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03339349
Brief Title
Weight-Based Enoxaparin Dosing and Real-Time Dose Adjustment in Orthopaedic Trauma
Official Title
Weight-Based Enoxaparin Dosing and Real-Time Dose Adjustment in Orthopaedic Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
October 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The rates of Venous thromboembolism (VTE) after orthopedic surgery are as high as 40-60% without prophylactic measures. Enoxaparin, a low-molecular-weight heparin, produces an anticoagulant effect by binding antithrombin, thereby accelerating antithrombin's inactivation of coagulation factor Xa (FXa), thus decreasing the likelihood of clot formation. Despite standard dosing enoxaparin prophylaxis, VTE rates in post-operative orthopedic trauma patients remain as high as 12.2%.The investigators will examine enoxaparin pharmacokinetics and test whether a clinical protocol for real-time enoxaparin dose adjustment can favorably alter the proportion of patients with in-range anti-Factor Xa (aFXa) levels. Outcomes will include peak and trough steady-state aFXa levels in response to standard and escalated doses of enoxaparin and the incidence of venous thromboembolism and bleeding events post-surgery. In the trauma and orthopaedic populations, patients with low initial aFXa levels are significantly more likely to develop deep venous thrombosis. Thus, this study has important implications for appropriate enoxaparin dose magnitude and frequency, and may ultimately help to decrease the substantial morbidity and mortality associated with post-operative VTE.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolus
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enoxaparin Metabolism
Arm Type
Experimental
Arm Description
Eligible patients will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.2-0.4 IU/mL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
Enrolled patients will receive real-time monitoring of peak and trough steady state anti-Xa levels. Out-of-range patients will receive real time dose adjustment of Enoxaparin using a clinical protocol developed with our inpatient pharmacists.
Primary Outcome Measure Information:
Title
Number of Participants with Venous Thromboembolism Events
Description
Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery
Time Frame
90 days
Title
Number of Participants with Bleeding Events
Description
Bleeding events requiring alteration in the course of care within 90 days of surgery
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Receiving orthopedic trauma surgery
Able to have enoxaparin initiated within 36 hours after procedure
Exclusion Criteria:
Intracranial bleeding/stroke
bleeding disorder
heparin-induced thrombocytopenia
creatinine clearance < 30 mL/minute
epidural catheter
serum creatinine > 1.6 mg/dL
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Weight-Based Enoxaparin Dosing and Real-Time Dose Adjustment in Orthopaedic Trauma
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