Weight-Based Enoxaparin Dosing and Real-Time Dose Adjustment in Orthopaedic Trauma

Venous Thromboembolism Clinical Trial

Official title:

Weight-Based Enoxaparin Dosing and Real-Time Dose Adjustment in Orthopaedic Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03339349
• Other study ID #: 102526
• Status: Completed
• Phase: Phase 2
• Start date: November 15, 2017
• Est. completion date: October 29, 2019

Study information

• Verified date: January 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 29, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Pulmonary Embolism
• Pulmonary Embolus
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Drug:
• Enoxaparin
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.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	90 days
Primary	Number of Participants With Bleeding Events	Bleeding events requiring alteration in the course of care within 90 days of surgery	90 days