Phase 3
N=37
Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device
Autoimmune Diseases · Renal Disorders · Hematologic Disorders · Oncologic Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01210716 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure — 81.9; 75.2 percentage of plasma removal efficiency — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Therapeutic plasma exchange (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fenwal, Inc.
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure |
81.9; 75.2 | <0.001 sig |
| SECONDARY Safety Measured by Adverse Events During the TPE Procedure |
7 | — |
Summary
This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma Exchange (TPE) is prescribed by their physicians.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01210716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.