Autoimmune Diseases Clinical Trial
Official title:
Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device
This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma Exchange (TPE) is prescribed by their physicians.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label
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