NCT01210716

Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Fenwal, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma Exchange (TPE) is prescribed by their physicians.

Detailed description

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.

Conditions

• Autoimmune Diseases
• Renal Disorders
• Hematologic Disorders
• Oncologic Disorders

Interventions

Type	Name	Description
DEVICE	Therapeutic plasma exchange	Patients are randomized to either Therapeutic plasma exchange procedures on AMICUS or Spectra first. The second procedure (based on time interval determined by physician) will be completed on the other instrument.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2010-09-28
• Last updated: 2013-09-23
• Results posted: 2013-09-23

Locations

4 sites across 1 country: United States