Autoimmune Diseases, Hematologic Disorders, Oncologic Disorders, Renal Disorders
Conditions
Keywords
Therapeutic plasma exchange, Autoimmune diseases, Kidney transplant, Hematologic disorders, Monoclonal gammopathy, Neurologic disorders
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.
Interventions
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.
Sponsors
Fenwal, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure | 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
| Measure | Time frame |
|---|---|
| Safety Measured by Adverse Events During the TPE Procedure | Adverse events were collected during each TPE procedure. |
Countries
United States
Participant flow
Recruitment details
The study opened enrollment on Sept 2010 at three hospitals-Yale New Haven Hospital, Mayo Clinic and University of Virginia Health System. A 4th site, BloodCenter of Wisconsin opened enrollment April,2011.
Pre-assignment details
Patients were required to complete two (2) procedures. First procedure was randomized to either Therapeutic plasma exchange on active comparator (AMICUS) or current device (Spectra). The second procedure was completed within approximately 5 weeks on the other device per physician prescription.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Population Includes groups randomized to receive Spectra first and AMICUS first. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Overall Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age Continuous | 50.7 years STANDARD_DEVIATION 13.7 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 37 |
| serious Total, serious adverse events | 0 / 37 |
Outcome results
Primary
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
Time frame: After completion of the TPE procedure.
Population: A total of 37 patients who consented and enrolled started the 1st procedure. Of these 37 patients, 33 patients completed the 1st procedure and started a 2nd procedure. Three patients did not complete the second procedure resulting in 30 patients with completed paired Test and Control procedures.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AMICUS (Test) | Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure | 81.9 percentage of plasma removal efficiency |
| Spectra (Control) | Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure | 75.2 percentage of plasma removal efficiency |
Comparison: A one-sample t-test on the mean of paired differences was used to evaluate the primary objective. Sample size was determined using historical data and the 95% chi-square upper confidence limit on the observed standard deviation of the paired differences. A minimum sample of 27 pairs was required to demonstrate the AMICUS procedure to be non-inferior to Spectra with a mean efficiency of plasma removal with a non-inferiority margin of 15% with at least 97.5% (one-sided) confidence and 90% power.p-value: <0.001paired t-test
Secondary
Safety Measured by Adverse Events During the TPE Procedure
Time frame: Adverse events were collected during each TPE procedure.
Population: Adverse events were summarized for enrolled subjects per protocol. 7 out of 37 enrolled subjects experienced adverse events during the study with a total of 12 adverse events reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AMICUS (Test) | Safety Measured by Adverse Events During the TPE Procedure | 7 participants |