A Phase 2 interventional study of Enoxaparin in Venous Thromboembolism, Deep Vein Thrombosis and Pulmonary Embolus, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by University of Utah · Phase 2, Interventional, and Other
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.
Exclusion Criteria:
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.
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.
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
Time frame: 90 days
Number of Participants With Bleeding Events
Bleeding events requiring alteration in the course of care within 90 days of surgery
Time frame: 90 days
| Milestone | Enoxaparin Metabolism |
|---|---|
| Started | 80 |
| Completed | 80 |
| Not completed | 0 |
Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery
| Participants | Enoxaparin Metabolism |
|---|---|
| Number of Participants With Venous Thromboembolism Events | 1 |
Bleeding events requiring alteration in the course of care within 90 days of surgery
| Participants | Enoxaparin Metabolism |
|---|---|
| Number of Participants With Bleeding Events | 1 |
Collected over Adverse Events were collected from post-operative day one or two while admitted to the hospital and 90 days post-operative.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enoxaparin Metabolism | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) |
| Event | Enoxaparin Metabolism |
|---|---|
| Splenic EmbolizationSurgical and medical procedures | 1/80 |
| Age, Categorical(Participants) | Enoxaparin Metabolism |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 57 |
| >=65 years | 23 |
| Sex: Female, Male(Participants) | Enoxaparin Metabolism |
|---|---|
| Female | 36 |
| Male | 44 |
| Race (NIH/OMB)(Participants) | Enoxaparin Metabolism |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 80 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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University of Utah