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

Study Overview
=================
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.

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

Conditions
-----------------
Autoimmune Diseases, Renal Disorders, Hematologic Disorders, Oncologic Disorders

Intervention / Treatment
-----------------
* Device: Therapeutic plasma exchange


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMICUS Therapeutic plasma exchange, TPE<br>Patients are randomized to either TPE on AMICUS or Spectra. | Device: Therapeutic plasma exchange<br>* 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.<br>* Other names: TPE;|
| Active Comparator: Spectra Therapeutic plasma exchange, TPE<br>Patients are randomized to either TPE on AMICUS or Spectra. | Device: Therapeutic plasma exchange<br>* 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.<br>* Other names: TPE;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Measured by Adverse Events During the TPE Procedure |  | Adverse events were collected during each TPE procedure. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Therapeutic plasma exchange, Autoimmune diseases, Kidney transplant, Hematologic disorders, Monoclonal gammopathy, Neurologic disorders