Clinical trial NCT01210716: Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device
Official title: Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Autoimmune Diseases
Renal Disorders
Hematologic Disorders
Oncologic Disorders
Keywords: Therapeutic plasma exchange
Autoimmune diseases
Kidney transplant
Hematologic disorders
Monoclonal gammopathy
Neurologic disorders
Lead sponsor: Fenwal, Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-28
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure
timeFrame: After completion of the TPE procedure.
Secondary outcomes:
measure: Safety Measured by Adverse Events During the TPE Procedure
timeFrame: Adverse events were collected during each TPE procedure.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Milwaukee
country: United States
facility: BloodCenter of Wisconsin
state: Wisconsin
Study officials:
affiliation: Fenwal, Inc.
name: Peyton Metzel, PhD
role: STUDY_CHAIR
References: