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

This study has been completed.
Sponsor:
Information provided by:
Fenwal, Inc.
ClinicalTrials.gov Identifier:
NCT01210716
First received: September 26, 2010
Last updated: June 23, 2011
Last verified: June 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Patients Prescribed TPE by the Treating Physician.
 Procedure: Therapeutic plasma exchange
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device

Further study details as provided by Fenwal, Inc.:

Primary Outcome Measures:
  • Percent efficiency of plasma removal during the therapeutic plasma exchange procedure [ Time Frame: Day 1 for outcome of first procedure, Week 5 for outcome of second procedure ] [ Designated as safety issue: No ]
    The calcuation is based on the amount of plasma that was processed through the machine compared to the amount of plasma that was actually removed by the machine during the procedure.


Secondary Outcome Measures:
  • Safety measured by Adverse Events During the TPE Procedure [ Time Frame: Day 1 during the TPE procedure and up to 5 weeks during the second TPE procedure ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: September 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMICUS TPE Procedure: Therapeutic plasma exchange
Therapeutic plasma exchange procedures.
Active Comparator: TPE on current device Procedure: Therapeutic plasma exchange
Therapeutic plasma exchange procedures.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01210716

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.
  More Information

No publications provided

Responsible Party: Peyton Metzel, PhD, Vice President Scientific, Clinical and Regulatory Affairs, Fenwal, Inc.
ClinicalTrials.gov Identifier: NCT01210716     History of Changes
Other Study ID Numbers: FCRP- 0210
Study First Received: September 26, 2010
Last Updated: June 23, 2011
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 21, 2013