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

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ClinicalTrials.gov Identifier: NCT01210716
Recruitment Status : Completed
First Posted : September 28, 2010
Results First Posted : September 23, 2013
Last Update Posted : September 23, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Autoimmune Diseases Renal Disorders Hematologic Disorders Oncologic Disorders Device: Therapeutic plasma exchange Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device
Study Start Date : September 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011


Arm Intervention/treatment
Experimental: AMICUS Therapeutic plasma exchange, TPE
Patients are randomized to either TPE on AMICUS or Spectra.
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.
Other Name: TPE

Active Comparator: Spectra Therapeutic plasma exchange, TPE
Patients are randomized to either TPE on AMICUS or Spectra.
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.
Other Name: TPE




Primary Outcome Measures :
  1. Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure [ Time Frame: 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 :
  1. Safety Measured by Adverse Events During the TPE Procedure [ Time Frame: Adverse events were collected during each TPE procedure. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210716


Locations
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United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
United States, Wisconsin
BloodCenter of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Fenwal, Inc.
Investigators
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Study Chair: Peyton Metzel, PhD Fenwal, Inc.
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Responsible Party: Fenwal, Inc.
ClinicalTrials.gov Identifier: NCT01210716    
Other Study ID Numbers: FCRP- 0210
First Posted: September 28, 2010    Key Record Dates
Results First Posted: September 23, 2013
Last Update Posted: September 23, 2013
Last Verified: September 2013
Keywords provided by Fenwal, Inc.:
Therapeutic plasma exchange
Autoimmune diseases
Kidney transplant
Hematologic disorders
Monoclonal gammopathy
Neurologic disorders
Additional relevant MeSH terms:
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Hematologic Diseases
Autoimmune Diseases
Disease
Pathologic Processes
Immune System Diseases