Phase 2
N=80
Weight-Based Enoxaparin Dosing and Real-Time Dose Adjustment in Orthopaedic Trauma
Venous Thromboembolism · Deep Vein Thrombosis · Pulmonary Embolus
Bottom Line
View on ClinicalTrials.gov: NCT03339349 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Number of Participants With Venous Thromboembolism Events — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Enoxaparin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Venous Thromboembolism Events |
1 | — |
| PRIMARY Number of Participants With Bleeding Events |
1 | — |
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.
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 1.6 mg/dL
Data sourced from ClinicalTrials.gov (NCT03339349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.