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临床试验/NCT00774748
NCT00774748已完成不适用

Once Weekly Subcutaneous Ports for the Administration of Anticoagulants - A Prospective Pharmacokinetic and Clinical Utilization Study

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Average Subcutaneous Anti-Xa Blood Levels

研究概览

简要总结

The purpose of this study is to ascertain whether subcutaneous ports are an effective and reliable way to administer the low molecular weight heparin (LMWH) enoxaparin to patients for the prevention or treatment of venous thromboembolism.

详细描述

Subcutaneous ports have recently been used to administer Low Molecular Weight Heparin (LMWH) to patients for the prevention or treatment of venous thromboembolism; however, no studies have been performed to evaluate the ports' reliability in delivering this type of drug. Hence, it is not known whether absorption of the drug is constant over the seven-day lifespan of the port. Although the use of subcutaneous ports is not currently the standard of care, health care providers are more frequently using this as an alternative method to direct injection of LMWH, particularly in pediatric patients.

The main advantage of subcutaneous ports is the decreased number of needle sticks when using the ports to administer the medication. However, it is possible that, due to potential repeated bleeding into the subcutaneous space at the port site or other factors, drug absorption may decrease over the seven day lifespan of the port, resulting in a decrease of plasma drug level. Subtherapeutic LMWH levels and, hence, ineffective anticoagulation may result. This study's aim is to determine if the current use of subcutaneous ports is a safe, effective and reliable way of administering LMWH for the purpose of anticoagulation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

入选标准

  • Subjects receiving once or twice daily dosing of therapeutic doses of subcutaneous Enoxaparin.
  • Subject has been on the same dose of Enoxaparin for at least one week.
  • Anticipated length of Enoxaparin treatment at least 4 weeks.
  • Age ≥ 18 years.
  • Subject demonstration of proper subcutaneous catheter care during one education session with the investigator.

排除标准

  • Chronic renal insufficiency with glomerular filtration rate < 30 mL/min.
  • Pregnancy
  • Venous thromboembolism within the last 4 weeks.

结局指标

主要结局

Average Subcutaneous Anti-Xa Blood Levels

时间窗: approximately 3 months

Blood levels taken from the first and last visits (when available) were combined to get an average. The anti-Xa test reports the low molecular weight heparin concentration in the blood.

次要结局

  • Percent Difference of Each Participant's Anti-Xa Levels Without Port and Day One of Using the Port(approximately 3 months)
  • Percent Difference of Each Participant's Anti-Xa Blood Levels Between Day 1 and Day 7(7 days)
  • Percent Difference of Each Participant's Subcutaneous Anti-Xa Levels(6 time points (for each participant) in approximately 3 months)
  • Standard Deviation of Participant's Own Glomerular Filtration Rate (GFR)(6 time points in approximately 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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