Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Blood samples to measure specific Arixtra® concentration
研究概览
简要总结
The purpose of this study is to determine a preventative dose of study drug, Arixtra® for patients with kidney disease. We will measure the blood levels of Arixtra® in patients with kidney disease and develop guidelines for dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Inpatients who are 18 years or older
- •estimated creatinine clearances between 20-50 ml/min
- •current hospitalization for a cancer-related abdominal, breast surgery or elective orthopedic surgery
- •able to give informed consent
- •need for prophylactic anticoagulant therapy for increased risk of a thrombotic episode
排除标准
- •Use of the following
- •clopidogrel, aspirin, or NSAID usage,(usage is prohibited while patients are participating in the study)
- •body weight < 50 kg
- •anticoagulation therapy for thrombosis or other indication
- •pregnant or breast-feeding
- •hypersensitivity to Arixtra®
- •thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of Arixtra®
- •bacterial endocarditis
- •brain malignancy
- •increased risk of bleeding.
研究组 & 干预措施
Arixtra
干预措施: fondaparinux sodium injection (Drug)
结局指标
主要结局
Blood samples to measure specific Arixtra® concentration
时间窗: • Three blood samples for PK analyses will be obtained within the 24 hour period immediately following either the third or fourth consecutive dose of Arixtra
peak level will be collected 2-3 hours after the dose interval level will be collected between peak and midpoint midpoint level will be collected 12 hours after the dose interval level will be collected midpoint and trough trough level will be collected just prior to the next scheduled dose
次要结局
- Frequency of bleeding events and new thrombotic events(Daily assessments will be made for bleeding and thrombosis)