Trial Outcomes & Findings for Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device (NCT NCT01210716)
NCT ID: NCT01210716
Last Updated: 2013-09-23
Results Overview
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
COMPLETED
PHASE3
37 participants
After completion of the TPE procedure.
2013-09-23
Participant Flow
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.
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.
Participant milestones
| Measure |
Spectra First, Then AMICUS
Patients randomized to Control (Spectra) procedure first. Second procedure performed was Test (AMICUS).
|
AMICUS First, Then Spectra
Patients randomized to Test (AMICUS) procedure first. Second procedure performed was Control (Spectra).
|
|---|---|---|
|
First TPE Procedure
STARTED
|
20
|
17
|
|
First TPE Procedure
COMPLETED
|
18
|
15
|
|
First TPE Procedure
NOT COMPLETED
|
2
|
2
|
|
Second TPE Procedure
STARTED
|
18
|
15
|
|
Second TPE Procedure
COMPLETED
|
15
|
15
|
|
Second TPE Procedure
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=30 Participants
Includes groups randomized to receive Spectra first and AMICUS first.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age Continuous
|
50.7 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
AMICUS (Test)
n=30 Participants
Each evaluable patient underwent one complete TPE procedure on the AMICUS separator.
|
Spectra (Control)
n=30 Participants
Each evaluable patient underwent one complete TPE procedure on the COBE Spectra separator.
|
|---|---|---|
|
Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure
|
81.9 percentage of plasma removal efficiency
Interval 68.0 to 96.0
|
75.2 percentage of plasma removal efficiency
Interval 61.0 to 88.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
AMICUS (Test)
n=37 Participants
Each evaluable patient underwent one complete TPE procedure on the AMICUS separator.
|
Spectra (Control)
Each evaluable patient underwent one complete TPE procedure on the COBE Spectra separator.
|
|---|---|---|
|
Safety Measured by Adverse Events During the TPE Procedure
|
7 participants
Interval 61.0 to 88.0
|
—
|
Adverse Events
Overall Study Population
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Overall Study Population
n=37 participants at risk
Includes groups randomized to receive Spectra first and AMICUS first.
|
|---|---|
|
Nervous system disorders
Dizzy/Light-Headed
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
2.7%
1/37 • Number of events 1
|
|
General disorders
Fatigue
|
2.7%
1/37 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Infiltration
|
2.7%
1/37 • Number of events 1
|
|
Nervous system disorders
Chills
|
2.7%
1/37 • Number of events 1
|
|
Nervous system disorders
Headache
|
2.7%
1/37 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rigors
|
2.7%
1/37 • Number of events 1
|
|
Nervous system disorders
Paresthesia
|
8.1%
3/37 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of data and/or information derived from the study requires prior review and approval by Sponsor.
- Publication restrictions are in place
Restriction type: OTHER