Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device
Study Details
Study Description
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 |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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 Names:
|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Safety Measured by Adverse Events During the TPE Procedure [Adverse events were collected during each TPE procedure.]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale University School of Medicine | New Haven | Connecticut | United States | 06520 |
| 2 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 3 | University of Virginia | Charlottesville | Virginia | United States | 22903 |
| 4 | BloodCenter of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Fenwal, Inc.
Investigators
- Study Chair: Peyton Metzel, PhD, Fenwal, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FCRP- 0210
Study Results
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 Detail | 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. |
| Arm/Group Title | Spectra First, Then AMICUS | AMICUS First, Then Spectra |
|---|---|---|
| Arm/Group Description | Patients randomized to Control (Spectra) procedure first. Second procedure performed was Test (AMICUS). | Patients randomized to Test (AMICUS) procedure first. Second procedure performed was Control (Spectra). |
| Period Title: First TPE Procedure | ||
| STARTED | 20 | 17 |
| COMPLETED | 18 | 15 |
| NOT COMPLETED | 2 | 2 |
| Period Title: First TPE Procedure | ||
| STARTED | 18 | 15 |
| COMPLETED | 15 | 15 |
| NOT COMPLETED | 3 | 0 |
Baseline Characteristics
| Arm/Group Title | Overall Study Population |
|---|---|
| Arm/Group Description | Includes groups randomized to receive Spectra first and AMICUS first. |
| Overall Participants | 30 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
25
83.3%
|
| >=65 years |
5
16.7%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
50.7
(13.7)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
15
50%
|
| Male |
15
50%
|
| Region of Enrollment (participants) [Number] | |
| United States |
30
100%
|
Outcome Measures
| Title | Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | AMICUS (Test) | Spectra (Control) |
|---|---|---|
| Arm/Group Description | Each evaluable patient underwent one complete TPE procedure on the AMICUS separator. | Each evaluable patient underwent one complete TPE procedure on the COBE Spectra separator. |
| Measure Participants | 30 | 30 |
| Mean (Full Range) [percentage of plasma removal efficiency] |
81.9
|
75.2
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | AMICUS (Test), Spectra (Control) |
|---|---|---|
| Comments | 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. | |
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | If the lower 97.5% confidence limit on the mean of the paired differences is greater than -15% of the Control group mean (i.e., p-value <=0.05), then the Test group will be considered non-inferior in the primary efficacy parameter to Control at the margin of 15%. | |
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | paired t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 6.69 | |
| Confidence Interval |
(1-Sided) 95% 4.0 to |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 6.970 |
|
| Estimation Comments | ||
| Title | Safety Measured by Adverse Events During the TPE Procedure |
|---|---|
| Description | |
| Time Frame | Adverse events were collected during each TPE procedure. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Overall Study Population |
|---|---|
| Arm/Group Description | Includes groups randomized to receive Spectra first and AMICUS first. |
| Measure Participants | 37 |
| Number [participants] |
7
23.3%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Overall Study Population | |
| Arm/Group Description | Includes groups randomized to receive Spectra first and AMICUS first. | |
All Cause Mortality |
||
| Overall Study Population | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Overall Study Population | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/37 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Overall Study Population | ||
| Affected / at Risk (%) | # Events | |
| Total | 7/37 (18.9%) | |
| Gastrointestinal disorders | ||
| Nausea | 1/37 (2.7%) | 1 |
| General disorders | ||
| Fatigue | 1/37 (2.7%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Rigors | 1/37 (2.7%) | 1 |
| Nervous system disorders | ||
| Dizzy/Light-Headed | 2/37 (5.4%) | 2 |
| Chills | 1/37 (2.7%) | 1 |
| Headache | 1/37 (2.7%) | 1 |
| Paresthesia | 3/37 (8.1%) | 4 |
| Skin and subcutaneous tissue disorders | ||
| Infiltration | 1/37 (2.7%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Publication of data and/or information derived from the study requires prior review and approval by Sponsor.
Results Point of Contact
| Name/Title | Sr. Mgr. Clinical Affairs |
|---|---|
| Organization | Fenwal, Inc |
| Phone | 847-550-5620 |
| carrie.pineda@fenwalinc.com |
- FCRP- 0210