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

Phase 3

Completed

• Conditions: Autoimmune Diseases; Renal Disorders; Hematologic Disorders; Oncologic Disorders
• Interventions: Device: Therapeutic plasma exchange

• Registration Number: NCT01210716
• Lead Sponsor: Fenwal, Inc.

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-26
• Study First Submitted QC: 2010-09-27
• Study First Posted: 2010-09-28
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2012-03-13
• Status Verified: 2013-09
• Results First Submitted QC: 2013-09-20
• Last Update Submitted: 2013-09-20
• Results First Posted: 2013-09-23
• Last Update Posted: 2013-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AMICUS Therapeutic plasma exchange, TPE	Therapeutic plasma exchange	Patients are randomized to either TPE on AMICUS or Spectra.
Spectra Therapeutic plasma exchange, TPE	Therapeutic plasma exchange	Patients are randomized to either TPE on AMICUS or Spectra.

Primary Outcome Measures

Name	Time	Method
Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure	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

Name	Time	Method
Safety Measured by Adverse Events During the TPE Procedure	Adverse events were collected during each TPE procedure.

Trial Locations

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