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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01210716
Other study ID # FCRP- 0210
Secondary ID
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 ADSOLĀ® 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


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
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