Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device
NCT ID: NCT01210716
Last Updated: 2013-09-23
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
37 participants
INTERVENTIONAL
2010-09-30
2011-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AMICUS Therapeutic plasma exchange, TPE
Patients are randomized to either TPE on AMICUS or Spectra.
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.
Spectra Therapeutic plasma exchange, TPE
Patients are randomized to either TPE on AMICUS or Spectra.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fenwal, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peyton Metzel, PhD
Role: STUDY_CHAIR
Fenwal, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FCRP- 0210
Identifier Type: -
Identifier Source: org_study_id