Twice Daily Enoxaparin Prophylaxis in Reconstructive Surgery Patients
Optimization of Enoxaparin Prophylaxis Using Real-time Anti-Factor Xa Levels in Major Reconstructive Surgery Patients
Blood clots that form in the extremities (deep venous thrombosis) and lungs (pulmonary embolus) are feared complications of reconstructive surgery. One in ten patients with symptomatic pulmonary embolus will be dead in 60 minutes. Patients with deep venous thrombosis can develop the post-thrombotic syndrome, known to be a major driver of poor quality of life. These phenomena, broadly known as venous thromboembolism (VTE), have substantial downstream ramifications, and the US Surgeon General and the American Society of Plastic Surgeons (ASPS), among others, have underscored the importance of VTE prevention in surgical patients. Reconstructive surgery, most commonly performed to fix traumatic injuries or defects after cancer excision, often involves borrowing tissue from adjacent or distant areas on the body; reconstructive surgery patients can routinely have surgical injury involving 20% or more of their total body surface area. Injury and resultant inflammation are known to increase metabolism of certain drugs, including those used to prevent VTE after surgery.
Enoxaparin is a blood-thinning medication that decreases likelihood of blood clot formation. Previous research has shown that reconstructive surgery patients who are given enoxaparin after surgery are less likely to develop VTE. However, despite receiving of a standard dose of enoxaparin, many patients still develop this life-threatening complication. The investigators believe that patients metabolize enoxaparin differently based on the degree of surgical injury created during reconstruction, and seek to critically examine enoxaparin metabolism in reconstructive surgery patients. The proposed research will evaluate how enoxaparin affects the blood based on standard, ASPS-recommended dosing after reconstructive surgeries; the investigators will also examine whether the extent of surgical injury alters metabolism as well. Enoxaparin effectiveness will be tracked using anti-Factor Xa (aFXa) levels. If subtherapeutic aFXa levels are observed, the study will also design, implement and test a clinical enoxaparin dose-adjustment protocol to achieve appropriate post-operative aFXa levels. Further research based on these data will examine reduction in VTE risk when aFXa-driven enoxaparin dosing is used.
研究概览
地位
详细说明
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
Utah
-
Salt Lake City、Utah、美国、84132
- University of Utah Hospitals
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria:
- Adult patients having plastic and reconstructive surgery who are placed on twice daily enoxaparin prophylaxis after surgery.
Exclusion criteria:
- Contraindication to use of enoxaparin.
- Intracranial bleeding/stroke, hematoma or bleeding disorder.
- Known heparin-induced thrombocytopenia
- Creatinine clearance ≤30mL/min
- Serum creatinine >1.6mg/dL
- Epidural anesthesia.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Enoxaparin prophylaxis
All enrolled patients will receive twice daily enoxaparin prophylaxis.
Patients with identified out of range peak anti-Xa levels will receive real time dose adjustment and will be considered as the experimental arm.
|
Patients will have peak and trough steady state anti-Xa levels drawn.
For patients with out of range peak levels, real time enoxaparin dose adjustment using a clinical protocol will be performed.
Repeat steady state levels will be checked.
其他名称:
|
实验性的:Real time dose adjustment
Patients with identified out of range peak anti-Xa levels will receive real time enoxaparin dose adjustment
|
Patients will have peak and trough steady state anti-Xa levels drawn.
For patients with out of range peak levels, real time enoxaparin dose adjustment using a clinical protocol will be performed.
Repeat steady state levels will be checked.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of patients with a 90-day VTE (either a 90-day DVT or 90-day PE)
大体时间:90 days
|
Outcome measure number one will be deep venous thrombosis or pulmonary embolus confirmed with imaging within 90 days of the initial surgery.
|
90 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of patients with a 90-day re-operative hematoma
大体时间:90 days
|
Outcome number two will be bleeding (hematoma) requiring return to the operating room within 90 days of the initial operation.
|
90 days
|
合作者和调查者
调查人员
- 首席研究员:Christopher Pannucci, MD MS、University Of Utah
出版物和有用的链接
一般刊物
- Pannucci CJ, Fleming KI, Agarwal J, Rockwell WB, Prazak AM, Momeni A. The Impact of Once- versus Twice-Daily Enoxaparin Prophylaxis on Risk for Venous Thromboembolism and Clinically Relevant Bleeding. Plast Reconstr Surg. 2018 Jul;142(1):239-249. doi: 10.1097/PRS.0000000000004517.
- Pannucci CJ, Fleming KI, Momeni A, Prazak AM, Agarwal J, Rockwell WB. Twice-Daily Enoxaparin among Plastic Surgery Inpatients: An Examination of Pharmacodynamics, 90-Day Venous Thromboembolism, and 90-Day Bleeding. Plast Reconstr Surg. 2018 Jun;141(6):1580-1590. doi: 10.1097/PRS.0000000000004379.
- Pannucci CJ, Fleming KI. Comparison of face-to-face interaction and the electronic medical record for venous thromboembolism risk stratification using the 2005 Caprini score. J Vasc Surg Venous Lymphat Disord. 2018 May;6(3):304-311. doi: 10.1016/j.jvsv.2017.10.016. Epub 2018 Feb 13.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 86052
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 统计分析计划 (SAP)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.