Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Fenwal, Inc.
- 入组人数
- 37
- 试验地点
- 8
- 主要终点
- Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure
研究概览
简要总结
This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma Exchange (TPE) is prescribed by their physicians.
详细描述
Therapeutic plasma exchange (TPE) is intended for efficient removal of circulating plasma, with the return of replacement fluids to the patient. In the majority of cases, the treatment goal is to selectively remove the substance directly responsible for the patient's disease process.
Fenwal's AMICUS separator platform is a centrifuge-based apheresis system which collects the blood components of interest and returns the remaining blood components along with saline back to a donor/patient. The device has been cleared for the following:
- The collection of platelets and plasma in Japan, Europe and the US (BK960005), 1996.
- The collection of mononuclear cells (MNCs) in the US (BK000047), 2002.
- The collection of a concurrent red blood cell (cRBC) product collected in ACD-A anticoagulant and stored in ADSOL® Preservation Solution (BK000039), 2002.
Fenwal has developed a new protocol on the AMICUS separator that enables the device to perform TPE procedures. The procedure is similar to the FDA cleared platelet and concurrent plasma collections, except that in TPE procedures the majority of plasma is retained and the red blood cells (RBCs), white blood cells (WBC) and the majority of the platelets are returned to the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Medically stable patients undergoing more than one TPE procedure who have provided signed informed consent prior to participation.
- •A physician's prescription for TPE for various non-emergent conditions.
- •Test and Control TPE procedures that would be expected to be completed within approximately five weeks.
排除标准
- •Patients under 18 years old.
- •Patients on an ACE inhibitor medication should discontinue use of this medication in accordance with institutional practices.
- •Patients with altered mental status that would prohibit the giving and understanding of informed consent.
- •Patients who have experienced a serious adverse event associated with the first TPE clinical study procedure.
结局指标
主要结局
Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure
时间窗: After completion of the TPE procedure.
The calculation is based on the volume of plasma that was processed through the machine compared to the volume of patient plasma that was actually removed during the procedure. Plasma Efficiency = (plasma removed/plasma processed)\*100
次要结局
- Safety Measured by Adverse Events During the TPE Procedure(Adverse events were collected during each TPE procedure.)