Fixed Versus Weight-Based Enoxaparin Dosing in Thoracic Surgery Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Number of Patients With in Range Initial Peak Xa Level
研究概览
简要总结
The aim of this research is to better understand how patient-level factors can be used to predict the appropriate enoxaparin dose to maximize venous thromboembolism (VTE) risk reduction and minimize bleeding.
详细描述
VTE encompasses deep venous thrombosis and pulmonary embolus and is the proximate cause of death in over 100,000 hospitalized patients per year 4,5. To put this in better context, VTE kills more people each year than the annual morbidity from motor vehicle crashes and breast cancer combined-and one third of these deaths are known to occur after surgical procedures 34. "Breakthrough" VTE events occur in patients despite the receipt of guideline-compliant chemical prophylaxis. These events can be frustrating for surgeons, can represent a resource and financial burden for hospital systems, and most importantly, can be life or limb threatening for patients.
Existing data from our group and others suggests that inadequate enoxaparin dosing, quantified by aFXa levels, represents a plausible explanatory mechanism for "breakthrough" VTE events that occur among thoracic surgery patients. This project will examine the pharmacodynamics of fixed dose enoxaparin (40mg/day) after VATS-this dose and frequency were the most commonly prescribed VTE chemical prophylaxis strategy in a recent survey of thoracic surgeons 35. If inadequate aFXa levels are observed with fixed enoxaparin dosing, the study will design, implement and test a weight-based dosing approach to optimize aFXa levels. The study will also examine how alteration of enoxaparin dose magnitude affects peak aFXa levels and risk for VTE and major bleeding events.
Aim 1: To evaluate peak steady-state aFXa levels in response to a fixed dose of enoxaparin prophylaxis (40mg once daily) in VATS patients.
Rationale: Over 12% of thoracic surgery patients have "breakthrough" VTE events despite receipt of fixed dose chemical prophylaxis 29. Fixed dose enoxaparin prophylaxis has been shown to be inadequate for the majority of patients in other surgical subspecialties.
Hypothesis: Peak steady state aFXa levels will be within the accepted range (0.3-0.5 IU/mL) in 40% of patients after VATS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •receiving Video-Assisted Thoracoscopic Surgery
- •able to have Enoxaparin initiated within 8 hours after procedure
排除标准
- •Contraindication to use of enoxaparin
- •Intracranial bleeding/stroke
- •Hematoma or bleeding disorder
- •Heparin-induced thrombocytopenia positive
- •Creatinine clearance less than or equal to 30 mL/min
- •Serum creatinine greater than 1.6 mg/dL
- •Epidural catheter
研究组 & 干预措施
Fixed Dose Enoxaparin
Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose.
干预措施: Fixed Dose Enoxaparin (Drug)
Variable Dose Enoxaparin
Eligible patients will be administered 0.5 mg/kg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose.
干预措施: Variable Dose Enoxaparin (Drug)
结局指标
主要结局
Number of Patients With in Range Initial Peak Xa Level
时间窗: 36 hours
Number of patients with in range initial peak Xa level
次要结局
- Number of Participants With Venous Thromboembolism Events or Death(90 days)
- Number of Participants With Bleeding Events(90 days)
研究者
Christopher Pannucci
Assistant Professor
University of Utah