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

Autoimmune Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01210716
• Other study ID #: FCRP- 0210
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2010
• Last updated: September 20, 2013
• Start date: September 2010
• Est. completion date: May 2011

Study information

• Verified date: September 2013
• Source: Fenwal, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Autoimmune Diseases
• Disease
• Hematologic Diseases
• Hematologic Disorders
• Kidney Diseases
• Oncologic Disorders
• Renal Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	BloodCenter of Wisconsin	Milwaukee	Wisconsin
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Fenwal, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	After completion of the TPE procedure.	No
Secondary	Safety Measured by Adverse Events During the TPE Procedure		Adverse events were collected during each TPE procedure.	Yes