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

Phase 2

Completed

• Conditions: Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolus
• Interventions: Drug: Enoxaparin

• Registration Number: NCT03339349
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-07
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-13
• Study Start: 2017-11-15
• Primary Completion: 2019-06-30
• Study Completion: 2019-10-29
• Results First Submitted: 2020-09-15
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-03
• Last Update Submitted: 2024-01-03
• Results First Posted: 2024-01-31
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enoxaparin Metabolism	Enoxaparin	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Venous Thromboembolism Events	90 days	Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery
Number of Participants With Bleeding Events	90 days	Bleeding events requiring alteration in the course of care within 90 days of surgery

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States