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

This study has been completed.

Sponsor:

Information provided by:

Fenwal, Inc.

ClinicalTrials.gov Identifier:

NCT01210716

First received: September 26, 2010

Last updated: June 23, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 26, 2010
Last Updated Date	June 23, 2011
Start Date ^ICMJE	September 2010
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 27, 2010)	Percent efficiency of plasma removal during the therapeutic plasma exchange procedure [ Time Frame: Day 1 for outcome of first procedure, Week 5 for outcome of second procedure ] [ Designated as safety issue: No ] The calcuation is based on the amount of plasma that was processed through the machine compared to the amount of plasma that was actually removed by the machine during the procedure.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01210716 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 27, 2010)	Safety measured by Adverse Events During the TPE Procedure [ Time Frame: Day 1 during the TPE procedure and up to 5 weeks during the second TPE procedure ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device
Official Title ^ICMJE	Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device
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 Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label
Condition ^ICMJE	Patients Prescribed TPE by the Treating Physician.
Intervention ^ICMJE	Procedure: Therapeutic plasma exchange Therapeutic plasma exchange procedures.
Study Arm (s)	Experimental: AMICUS TPE Intervention: Procedure: Therapeutic plasma exchange Active Comparator: TPE on current device Intervention: Procedure: Therapeutic plasma exchange
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	37
Completion Date	May 2011
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Medically stable patients undergoing more than one TPE procedure who have provided signed informed consent prior to participation. A physician's prescription for TPE for various non-emergent conditions. Test and Control TPE procedures that would be expected to be completed within approximately five weeks. Exclusion Criteria: Patients under 18 years old. Patients on an ACE inhibitor medication should discontinue use of this medication in accordance with institutional practices. Patients with altered mental status that would prohibit the giving and understanding of informed consent. Patients who have experienced a serious adverse event associated with the first TPE clinical study procedure.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01210716
Other Study ID Numbers ^ICMJE	FCRP- 0210
Has Data Monitoring Committee	No
Responsible Party	Peyton Metzel, PhD, Vice President Scientific, Clinical and Regulatory Affairs, Fenwal, Inc.
Study Sponsor ^ICMJE	Fenwal, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Fenwal, Inc.
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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