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OpenTrials
Completed

NCT Number: NCT03339349

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enoxaparin

Drug

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 outcomes

  1. Number of Participants With Venous Thromboembolism Events

    Time frame: 90 days

    Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery

  2. Number of Participants With Bleeding Events

    Time frame: 90 days

    Bleeding events requiring alteration in the course of care within 90 days of surgery

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 13, 2017
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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