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

Fenwal, Inc.

Status and phase: Completed; Phase 3

Conditions: Hematologic Disorders; Renal Disorders; Autoimmune Diseases; Oncologic Disorders

Treatments: Device: Therapeutic plasma exchange

Study type: Interventional

Funder types: Industry

Identifiers

NCT01210716

FCRP- 0210

Details and patient eligibility

About

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

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Medically stable patients undergoing more than one TPE procedure who have provided signed informed consent prior to participation.
2. A physician's prescription for TPE for various non-emergent conditions.
3. Test and Control TPE procedures that would be expected to be completed within approximately five weeks.

Exclusion criteria

1. Patients under 18 years old.
2. Patients on an ACE inhibitor medication should discontinue use of this medication in accordance with institutional practices.
3. Patients with altered mental status that would prohibit the giving and understanding of informed consent.
4. Patients who have experienced a serious adverse event associated with the first TPE clinical study procedure.

Trial design

37 participants in 2 patient groups

AMICUS Therapeutic plasma exchange, TPE

Experimental group

Description:

Patients are randomized to either TPE on AMICUS or Spectra.

Treatment:

Device: Therapeutic plasma exchange

Spectra Therapeutic plasma exchange, TPE

Active Comparator group

Description:

Patients are randomized to either TPE on AMICUS or Spectra.

Treatment:

Device: Therapeutic plasma exchange