A Phase II Trial Using Fondaparinux in Patients With Confirmed or Suspected Heparin-Induced Thrombocytopenia (HIT)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Participants Showing Clinically Significant Bleeding
研究概览
简要总结
The purpose of this study is to determine how safe and effective fondaparinux is in treating patients with suspected or confirmed heparin-induced thrombocytopenia (HIT).
详细描述
Currently, standard treatment of HIT involves the transition from a direct thrombin inhibitor (a type of anticoagulant or "blood thinner") to warfarin, a different type of anticoagulant. Direct thrombin inhibitors (DTIs) require IV administration and frequent blood draws for dose adjustments, which can lead to prolonged hospitalization. DTIs also affect blood test measurements, making it difficult to determine proper dosages of warfarin.
Fondaparinux is a drug that is approved by the FDA for the treatment of blood clots in deep veins and in the lungs. Fondaparinux is not FDA approved for the treatment of HIT. However, an increasing number of doctors are using fondaparinux instead of DTIs to treat HIT. Although fondaparinux appears to be more convenient and predictable than DTI medications, more research is needed to support its use as a treatment for HIT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •high risk for HIT based on "Four Ts score" of 6 or more
排除标准
- •pulmonary emboli at the time of enrollment
- •arterial thrombosis at the time of enrollment
- •limb threatening phlegmasia cerulea dolens at the time of enrollment
- •Calculated Creatinin Clearance less than 50 ml/hr
- •platelet count less than 50
- •Weight less than 50 kg
- •pregnancy
- •allergy to fondaparinux
- •bacterial endocarditis
- •history of neuraxial anesthesia and post-operative indwelling epidural catheter
- •active major bleeding (hemodynamically significant or requiring transfusions)
- •inability to give informed consent
研究组 & 干预措施
Fondaparinux
daily subcutaneous injection of fondaparinux (7.5-10 mg)
干预措施: fondaparinux (Drug)
Fondaparinux
daily subcutaneous injection of fondaparinux (7.5-10 mg)
干预措施: warfarin (Drug)
结局指标
主要结局
Number of Participants Showing Clinically Significant Bleeding
时间窗: 4 weeks after INR reaches 2 or more
Clinically significant bleed is defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux
次要结局
- the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux(4 weeks after INR reaches 2 or more)
研究者
Goetz Kloecker
Associate Professor
University of Louisville