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

Fenwal, Inc.37 enrolled

Overview

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

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

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Autoimmune Diseases Renal Disorders Hematologic Disorders Oncologic Disorders

Interventions

Therapeutic plasma exchangeDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Yale University School of Medicine

New Haven, Connecticut, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Virginia

Charlottesville, Virginia, United States

BloodCenter of Wisconsin

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

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

Time frame: After completion of the TPE procedure.

Secondary Outcomes

Safety Measured by Adverse Events During the TPE Procedure

Time frame: Adverse events were collected during each TPE procedure.

Data from ClinicalTrials.gov

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