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.

Study Overview

• Status: Completed
• Conditions: Autoimmune Diseases; Oncologic Disorders; Renal Disorders; Hematologic Disorders
• Intervention / Treatment: Device: Therapeutic plasma exchange

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School of Medicine
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • BloodCenter of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AMICUS Therapeutic plasma exchange, TPE; Patients are randomized to either TPE on AMICUS or Spectra.	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.; Other Names: TPE
Active Comparator: Spectra Therapeutic plasma exchange, TPE; Patients are randomized to either TPE on AMICUS or Spectra.	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.; Other Names: TPE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange 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	After completion of the TPE procedure.

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety Measured by Adverse Events During the TPE Procedure	Adverse events were collected during each TPE procedure.

Collaborators and Investigators

• Sponsor: Fenwal, Inc.
• Investigators: Study Chair: Peyton Metzel, PhD, Fenwal, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: September 26, 2010
• First Submitted That Met QC Criteria: September 27, 2010
• First Posted (Estimate): September 28, 2010

Study Record Updates

• Last Update Posted (Estimate): September 23, 2013
• Last Update Submitted That Met QC Criteria: September 20, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Kidney transplant; Autoimmune diseases; Therapeutic plasma exchange; Hematologic disorders; Monoclonal gammopathy; Neurologic disorders
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Disease; Hematologic Diseases; Autoimmune Diseases
• Other Study ID Numbers: FCRP- 0210