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

• ClinicalTrials.gov Identifier: NCT01210716
• Recruitment Status: Completed
• First Posted: September 28, 2010
• Results First Posted: September 23, 2013
• Last Update Posted: September 23, 2013
• Sponsor: Fenwal, Inc.
• Information provided by (Responsible Party): Fenwal, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Autoimmune Diseases; Renal Disorders; Hematologic Disorders; Oncologic Disorders	Device: Therapeutic plasma exchange	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device
• Study Start Date: September 2010
• Actual Primary Completion Date: May 2011
• Actual Study Completion Date: May 2011

Arms and Interventions

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 Name: 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 Name: TPE

Outcome Measures

Primary Outcome Measures :

1. Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure [ Time Frame: 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

Secondary Outcome Measures :

1. Safety Measured by Adverse Events During the TPE Procedure [ Time Frame: Adverse events were collected during each TPE procedure. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Connecticut

Yale University School of Medicine

New Haven, Connecticut, United States, 06520

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22903

United States, Wisconsin

BloodCenter of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Fenwal, Inc.

Investigators

• Study Chair: Peyton Metzel, PhD; Fenwal, Inc.

More Information

• Responsible Party: Fenwal, Inc.
• ClinicalTrials.gov Identifier: NCT01210716
• Other Study ID Numbers: FCRP- 0210
• First Posted: September 28, 2010
• Results First Posted: September 23, 2013
• Last Update Posted: September 23, 2013
• Last Verified: September 2013

Keywords provided by Fenwal, Inc.:

Therapeutic plasma exchange; Autoimmune diseases; Kidney transplant; Hematologic disorders; Monoclonal gammopathy; Neurologic disorders

Additional relevant MeSH terms:

Hematologic Diseases; Autoimmune Diseases; Disease; Pathologic Processes; Immune System Diseases